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Jacobs Journal of Physical Rehabilitation Medicine

Influence of a Custom-made Dynamic Ankle-Foot Orthosis with a Reciprocant Ankle Joint System called Neuroswing on Walking Spatio-Temporal Parameters in Patients affected by a Neurological Gait Schema: A Comparative Investigational StudyMaurizio Falso1*, Md, Eleonora Cattaneo1 Psy, Marco Zucchini2 Orth, Franco Zucchini2 Orth

1Section of Neurological Rehabilitation, Clinical Institute Città di Brescia, Brescia, Italy²Il Podologo S.r.l., Brescia Italy

*Corresponding author: Dr. Maurizio Falso (MD), Physical Medicine and Rehabilitation. Section of Neurological Rehabilitation – Clinical

Institute Città di Brescia – Via Gualla 15, 25128, Brescia, Italy, Tel: 349.4971729; Email: falsomaurizio@libero.it

Received: 10-31-2018

Accepted: 11-15-2018

Published: 11-19-2018

Copyright: © 2018 Maurizio Falso

Comparative Investigational Study

Cite this article: Maurizio Falso. Influence of a Custom-made Dynamic Ankle-Foot Orthosis with a Reciprocant Ankle Joint System called Neuroswing on Walking Spatio-Temporal Parameters in Patients affected by a Neurological Gait Schema: A Comparative Investigational Study. J J Physical Rehab Med. 2018, 4(2): 028.

Abstract

Background

Orthoses need to support physiotherapy as well as surgical treatment. Related to patient’s pathological gait, physician’s requirements and the rehabilitative goals, orthotists must produce an orthoses that using an adjustable ankle joint system with preloaded disc springs can store the energy brought in by the body weight and produce a tuning effect on patient’s gait and sense of balance. Many studies established the functional value of common and well-known ankle foot orthoses (AFOs) by developing pathological gait. Solid AFOs (SAFOs) do not allow any ankle movements and are used for patients with spasticity. The so-called Floor Reaction AFO (FRAFO) is a ventral shell orthoses that blocks any ankle joint movement, enables the knee extension in terminal stance, but is controindicated in patients with an hyperextended knee. HAFO or classical hinged AFO are designed with elastomer spring joints without any spring effect or any dorsal stop that blocks any plantar flexion and enables a dorsiflexion with defined pivot point in the anatomical ankle joint. PLS-AFOs or posterior leaf spring AFOs, have commonly a high carbon spring effect but do neither have a pivot point, a defined or adjustable range of movement nor an adjustable alignment.

Aim

To perform a comparative spatio-temporal gait evaluation by using SAFO or solid AFO (Codivilla spring) and FRAFO or so-called floor reaction AFO (Toe-Off) vs an innovative dynamic hinged Ankle-Foot-Orthoses designed with an innovative ankle joint system called Neuroswing (DAFONS) on patients affected by different pathological gait patterns secondary to different central nervous system damages.

Study design

Comparative investigational study.

Setting

A rehabilitation institute for the treatment of neurological gait disorders.

Population

Five patients affected by different neurological gait pattern were recruited for the aim of this study in line with an informed consent and simple inclusion (cooperating patient, evidence of pathological gait pattern, bearer of a DAFONS) and exclusion (not

cooperating patient, evidence of a physiological gait pattern, not bearer of a DAFONS) criteria.

Methods

In line with a personalized operating flow-chart, each patient underwent to a:

a. visual gait analysis (VGA), focusing attention on orthostatic and orthodynamic trunk attitude, core stability and hip range of movement in stance and swing, knee and ankle stability and movement attitude in stance and swing, analytical and global movement attitude of the trunk-hip-lower limb unit, biomechanical movement profile of the ankle during the stance and swing phase of gait

b. spatio-temporal BTS-G Walk sensor gait analysis, focusing attention on the average value of the Test duration (sec), Gait speed (m/sec), Gait cadence (steps/min), N° of step cycle on the left side, N° of step cycle on the right side, Stride lenght on the left and on the right (% cycle lenght), Stance phase duration on the left and on the right (% cycle), Swing phase duration on the left and on the right (% cycle), Double gait support duration on the left and on the right (% cycle).

Patient’s observational and instrumental evaluation was performed under 4 conditions: 1) without AFO or in free walk; 2) wearing a Codivilla spring; 3) wearing a FRAFO (Toe-Off); and 4) wearing a DAFONS.

Main outcomes and results

A task-specific evaluation was made at time T0 (clinical and functional outpatient evaluation), time T1 (1 week from T1, planning stage of DAFONS manufacturing), time T2 (3 days from T1, DAFONS custom-made manufacturing and orthoses proof before delivery), and time T3 (10 days from T2, delivery and evaluation of DAFONS approriateness) using: a. objective gait analysis (VGA), b. spatio-temporal BTS-G Walk sensor gait analysis by using a wireless device consisting of a triaxial accelerometer and gyroscope with a magnetometer inside. After our comprehensive evaluation we observed at time T3:

• an amelioration of gait quality (increase of patient’s trunk and hip dynamic stability, amelioration of the knee and ankle orthostatic and orthodynamic control on the affected and unaffected side) with the use of DAFONS in all those patients (P1, P3 and P5) who showed a neurocognitive competence with a related functional grade of neurorehabilitative re-learning attitude of the physiological gait pattern and with a compromised perceptive control of gait and core stability;

• a different trend of spatio-temporal raw data in each patient in our study conditions;

• a decrease of test duration by using DAFONS that cannot be

Jacobs Publishers 2observed in the other study conditions in all patients;

• an increase of test duration in patient P1 and P5 (> in P5) compared to patients P2, P3 and P4 by using Toe-Off orthosis that cannot be observed by using Codivilla spring and DAFONS;

• in line with the non parametric Friedman test, a statistical significant difference [Χ2(3)=9; p=0,029] in the test duration (sec) by using Toe-Off orthosis vs DAFONS (76,62 vs 51,04) (Z=-2,023; p<0,05) and by using Codivilla spring vs Toe-Off orthosis (57,44 vs 76,62 (Z=-2,023; p<0,05);

• no statistical significant differences in the comparative BTS spatio-temporal analysis of the other study conditions (FW vs Codivilla, FW vs Toe-Off, FW vs DAFONS and Codivilla vs DAFONS).

Conclusions

In line with our observational gait analysis (VGA), we observed that by correcting the static alignment and physisological range of movement of patient’s ankle joint with the use of DAFONS we can influence and modulate the static and dynamic knee attitude and patient’s postural stability during gait. We also concluded that fine tuning to an individual patient can be achieved by adjusting the degree of AFO’s exoskeleton hardness through a specific carbon structure or by changing three mechanical properties of our ankle joint: a. orthosis ankle joint alignment, b. spring force, c. ankle joint range of motion (ROM).

Keywords: Ankle Foot Orthoses; Neurological Gait Pattern; Kinematic Gait Analysis

Abbreviations:

ROM :Range of Movement; AFO : Ankle Foot Orthoses; SAFOs : Solid AFOs; FRAFO : Floor Reaction AFO; HAFO : Hinged AFO; PLS-AFO : Posterior Leaf Spring AFO; DAFONS : Dynamic Hinged Ankle Foot Orthoses with Neuroswing; EMG : Electromyography; SEMG : Surface EMG; CNS : Central Nervous System; PNS : Peripheral Nervous System; VGA : Visual Gait analysis

Introduction

Walking is one of the most important activities for people to engage in their environment [1]. When people are unable to walk, this limits a persons’ freedom, with a negative impact on the quality of life and a related increase of the hospitalization

risk. We can analyze the dynamic balance during ambulation with the acquisition of instrumental spatio-temporal parameters, as the stright lenght, gait cadence and gait velocity (etc.) defined by Fritz S. et al. [2] as “the sixth sense of life morbility and mortality”. In the last years many gait labs used innovative technical devices for the computerized movement analysis in patients affected by neurological gait schema: Elite, stabilometric platforms, surface elektromyography (SEMG) and wireless devices as the so-called BTS G-Walk sensor [3]. Similarly, clinicians and physioterapists made use of different types of ankle foot orthoses (AFO) in the short or long-term rehabilitative treatment of mechanical or neurological gait disorders [4,5]. From a biomechanical point of view, ankle foot orthoses (AFO) can be divided unappropriately in static ankle foot orthoses (SAFO) or not ankle joint assisted orthoses and dynamic ankle foot orthoses (DAFO) or ankle joint assisted orthoses. As observed by Novacheck et al. [6], a single orthoses cannot satisfy all functional goals that can be assumed in a neuromodulated and assisted treatment of a pathological gait pattern. For this reason, using the right modern materials (carbon, kevlar and other synthetics of hardness grades) and material properties in the right place of an individualized and custom-made orthoses, many technicians tried to propose ergonomic and individualized orthotic design in line with patient’s functional needs [7].

Recent studies described the usefullness of AFOs. While some studies compared the usefullness profile of all orthoses [8] a recent study of Zollo et al. [9] defined the functional value of DAFOs (dynamic ankle foot orthoses), compared with SAFOs (solid ankle foot orthoses), on the muscle recruitment pattern of the lower limbs using a typical surface EMG analysis.

The purpose of the current study was to perform a comparative spatio-temporal gait evaluation by using SAFO or solid AFO (Codivilla spring) and FRAFO or so-called floor reaction AFO (Toe-Off) vs an innovative dynamic hinged Ankle-Foot-Orthoses designed with an ankle joint system called Neuroswing (DAFONS) on patients affected by different pathological gait patterns secondary to central nervous system damages.

Materials and Methods

Subjects

Five patients (3 males and 2 females; mean age 33+/- 18yy) affected by different neurological gait pattern were recruited for the aim of this study in line with an informed consent and simple inclusion criteria (cooperating patient, evidence of pathological gait pattern, bearer of a DAFONS) and exclusion criteria (not cooperating patient, evidence of a physiological gait pattern, not bearer of a DAFONS).

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P1 P2 P3 P4 P5 Gender Male Female Male Male Female

Age 26 54 16 49 17 Weight (Kg) 90 70 65 78 42 Height (cm) 182 172 170 178 150

Date of damage event 2011 1992 2013 1998 1999

Damage Peripheral nervous system

Multiple sclerosis

Ischemic spine lesion Stroke PCI

Side affected Right Right Left Right Bilateral Movement disorder Unilateral

hypotonic drop-foot

Monolateral spastic foot supination

Spinal stiff gait with a distal foot

supination

Spastic right hemiparesis

Double spastic-dystonic

hemiplegia Modified Ashworth Scale (MAS) of the affected lower limb

2 3++ 3++ 4++ 4--

Rehabilitative treatment pre-

recruitment

Yes No Yes No No

Botulinum toxin therapy pre-recruitment

No Yes No Yes Yes

Orthoses used before recruitment

Codivilla Codivilla Dyna-Ankle Codivilla SAFO custom made

Table 1. Overview of the study population demographic, etiologic and treatment characteristics at recruitment time.

Clinical and functional evaluation of all patients was made at baseline (time T0) by MF in the Spasticity and Movement Disorders Ambyulatory of the Clinical Institute of Città di Brescia. In accordance with the aim of this study, we recruited patients affected by neurological gait disorders who were candidated to use our innovative dynamic hinged Ankle-Foot-Orthoses designed with an innovative ankle joint system called Neuroswing (DAFONS), provided by the Prosthetic and Orthothic Lab – Il Podologo S.r.l (Brescia). In table I we resume the demographic and etiologic characteristics as well as the type of AFO used by the study population. At recruitment time, our patients showed different pathological gait pattern:

- patient 1 (P1): compressive foot trauma with a secondary local neuroalgodystrophy that caused a right foot supination during gait and a related spontaneous distal limb clonus

- patient 2 (P2): multiple sclerosis with a right supination gait pattern and a double bump attitude during walking

- patient 3 (P3): lumbar ischemic spine lesion, with a right knee hyperextension and a flat foot pattern during the stance phase of gait

- patient 4 (P4): left hemisperic brain stroke with a related right hemiplegia, characterized by a distal flexed wrist and flexed elbow on the upper limb and a right knee hyperextension and a toe walking pattern during the stance phase of gait

- patient 5 (P5): cerebral palsy with a double hemiplegic gait pattern related to a flat foot in stance and a related knee recurvatum during walking.

Study design

In line with a personalized operating flow-chart (see figure 1), each patient underwent a task-specific evaluation at time T0, T1, T2 and T3:

a. T0 (baseline), patients underwent a clinical and functional evaluation (made by the Specialist Doctor in Physical Medicine and Rehabilitation);

b. T1 (1 week from baseline T0), after an equipé breefing (medical doctor or MD and Orthotic Technician) with the definition of functional goals and techincal orthotic purposes, a DAFO manufacturing project for each patient was established with the observation of patients’ pathological limb attitude and realizing an ergonomic and individualized custom-made AFO;

c. T2 (3 days from T1), after a distal limb plaster-cast aquisition of each patient recruited, the orthotic technician begin the DAFONS manufacturing that goes on for one week; to optimize the custom-made properties of the manufactured DAFO, each patient was invited to wear the DAFO and, if appropriate, to use it during walking;

d. T3 (10 days from T2), at the end of DAFO manufacturing process, the orthotic technician will analyze the appropriateness and functional profile of the AFOs by a) evaluating patients’ compliance and ergonomic sensation in the use of the AFO manufactured (with eventual structural and functional adaptation made before final orthoses delivery); b) analyzing patients’ individual spatio-temporal gait pattern during, a free walk condition and wearing 3 types of orthoses, by using the BTS G-Walk sensor device (a simple wireless device consisting of a triaxial accelerometer and gyroscope with a magnetometer inside that give us a solution for an accurate and quick measurement of spatio-temporal gait parameters).

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Figure 1

MD (Specialist in Physical Medicine and Rehabilitation)

Orthotic Technician

Clinical and functional evaluation and DAFONS indication Inclusion in our standardized

rehabilitative treatment course

TO T1 T2 T3 T4

Figure 1. Model of our personalized study operating flow-chart design.

After gait analysis, patients recruited were evaluated by the Physioterapist and began a standardized rehabilitative treatment course.

Visual and instrumental gait analysis

Patients underwent a short-term comparative evaluation of the functional effect of three types of AFO (Codivilla spring, Toe-Off and DAFONS) using a:

• Visual gait analysis

At time T3, each patient underwent an off line visual gait analysis (VGA) made by the same MD. VGA does not us any apparatus. It is a simple observational gait evaluation, made by a clinician, focusing attention on specific aspects of patient’s gait pattern; the term “off-line” indicates the indirect evaluation of gait pattern by using a video registration made before. We observed the gait performance in 4 study conditions: in free-walk (without orthoses), with Codivilla spring, with Toe-Off and with a custom-made DAFONS. The visual gait analysis focused on:

• orthostatic and orthodynamic trunk attitude

• core stability and hip movement in stance and swing phase of gait

• knee and ankle stability and movement attitude in stance and swing phase of gait

• analytical and global movement attitude of the trunk-hip-lower limb unit

• ankle movement during stance and swing phase of gait

• Spatio-temporal BTS-G Walk sensor gait analysis

At time T3, we analyzed patients’ individual spatio-temporal gait pattern during a free walk condition (without orthoses) and wearing 3 types of orthoses (Codivilla spring, Toe-Off and DAFONS), by using the BTS G-Walk sensor device. This computerized gait analysis collected the average:

• Test duration (sec)

• Gait speed (m/sec)

• Gait cadence (steps/min)

• N° of step cycle on the left side

• N° of step cycle on the right side

• Stride lenght on the left and on the right (% cycle lenght)

• Stance phase duration on the left and on the right (% cycle)

• Swing phase duration on the left and on the right (% cycle)

• Double gait support duration on the left and on the right (% cycle)

In each study condition, patients were instructed to walk with a self-selected speed along a 10m walkway for three times; during the trial, patients were allowed to use an ambulation aid or were supported by a care-giver.

Study devices

BTS G-Walk sensor device

BTS G Walk sensor consists in a simple device that allowes an accurate and quick measurement of spatio-temporal gait parameters. From a technical and functional point of view. The BTS G Walk sensor is a wireless device (see figure 2) consisting of:

a. Triaxial accelerometer

b. Triaxial gyroscope

c. Magnetometer

This device is able to communicate with the software of a computer using a bluetooth connection with a range up to a distance of 20m. The spatio-temporal data, automatically acquired with this device, represent the result of a software comparison with normative data well-known and still defined for each gait parameter. During our trial (see figure 3) the device will be positioned on level L5 of patient’s spine and secured by an ergonomic belt allowing free body movement.

AFOs

- SAFO (Solid Ankle Foot Orthoses)

Codivilla spring (see figure 4)

- Univalve orthoses with a posterior leg shell

- Polipropylene plastic material

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Figure 2. BTS G-Walk sensor.

- High flexible orthoses with a low spring control in push-off phase of gait

- Prefabricated AFO

Figure 3. BTS G-Walk sensor body positioning on spinal L5.

Figure 4. Codivilla DAFO

- FRAFO (Floor Reaction Ankle Foot Orthoses)

Toe-Off (see figure 5)

- Univalve orthoses with an anterior leg shell

- Pre-resinated carbon fiber AFO

- Low deformability and medium flexibility AFO; the effect produced during the gait cycle by this kind of orthoses will be the low capability of control of spring effect deriving by the energy brought in by the body weight during the push-off phase of gait.

Jacobs Publishers 6- Low ergonomic orthoses design that offers a very low ankle ROM and cannot be adapted to patient’s pathological foot attitude (equinovarus foot, pronated foot, flat foot, toe walking)”; this property can be explained by the low deformability and medium flexibility offered by the design and material of this kind of orthoses.

- DAFONS (Dynamic Ankle Foot orthoses designed with Neuroswing)

Theoretical premise

- Realizing an orthostatic stability we can increase patient’s sense of balance and core stability by using an individualized plurimodulable distal or proximal/distal leg device (AFO)

- Through an individual regulation and adjustment of ankle alignment in swing we can realize a time and grade modulation of swing phase of gait

- Regulating the swing phase we can optimize the lever control of gait during the so-called heel contact phase

- Regulating the dynamic lever spring force we can modulate, optimize and store the energy brought in by the body weight supporting in this way ankle’s push-off when released and controlling the step lenght

- Resulting a real gait assistance device by modulating patient’s individual gait pattern it can be considered a usefullness energy save system and an individualized:

a. peripheral neuro-facilitation of gait cycle (peripheral perceptive facilitation)

b. neurorehabilitative re-learning device of physiological gait pattern (peripheral assisted neuroplasticity facilitation)

c. device that can increase patient’s motor abilities and quality of life in his personal milieu

Figure 5. Toe-Off DAFO.

• Structural and construction properties of DAFONS

- Bivalve orthoses (see figure 6) with a dorsal or ventral leg component and a foot component, designed with an innovative ankle joint system called Neuroswing;

- Not pre-resinated carbon fiber AFO with a 1/3 anterior plantar aramidic fiber component (KEVLAR) with an high elastic response;

- Task and functional specific custom-made orthosis, with an high ergonomic profile, respect of patient’s ankle joint attitude and with a singular modulable and reciprocant lateral malleolar ankle joint system;

- Dynamism, plasticity and stability as techincal properties of the esoskeletal unit;

Figure 6. HAFONS (by M.Z. – Il Podologo Srl).

- A device that allowes to optimize the lever control of gait during the so called heel contact phase, modulate, optimize and store the energy brought in by the body weight during gait and that can be considered as usefullness energy save system;

Figure 7. Neuroswing ankle joint system (by www.fior-gentz.de)

Neuroswing (see figure 7) represents an innovative ankle joint system, having a plurimodulate regulation of ankle “attitude”, that integrated in the carbon scheleton of an AFO - DAFO or KAFO, can be used in the rehabilitative treatment of pathological gait schema secondary to CNS damage (stroke,

Jacobs Publishers 7PC, several brain or spinal damage) or PNS damage (peripheral nervous deafferentation, neuropathy, etc).

To individualize the interaction between patient’s pathological gait attitude and the functional response given by this plurimodulate joint system, clinicians can (see figure 8 and 9):

1. regulate ankle ROM by using a set screw (max 10 degree in ankle extension and 15 degree in ankle flexion starting from the neutral ankle position);

2. regulate an optimal and defined “pivot point” or grade of tibia inclination (realize an optimal lever effect by regulating tibia inclination in flexion or extension = adaptation to patient’s pathological gait pattern) by using an alignment screw;

3. regulate the spring force in plantar and dorsiflexion by using 5 types of exchangeable spring units which store the energy brought in by the body weight during gait.

Figure 8. Five exchangeable spring units (by www.fior-gentz.de)

Figure 9. Inside structural profile of NS (by www.fior-gentz.de)

• AFOs comparative profile

In the multitude of appliance by using dynamic ankle foot orthoses (DAFO), the introduction of DAFONS allowes us to define (see table 2) an analytical AFO comparative profile that can help clinicians to define the optimal orthotic solution for each patient.

Data analysis

Spatio-temporal gait analysis was made using the statistical software SPSS (version 22). Friedman non-parametric tests with Wilcoxon post-hoc test were used to realize six comparative analysis of each patient performance: 1) free-walk or without orthosis vs Codivilla spring; 2) free-walk or without orthosis vs Toe-Off; 3) free-walk vs DAFONS; 4) Codivilla spring vs Toe-Off; 5) Codivilla spring vs DAFONS; 6) Toe-Off vs DAFONS. The significance level was set to p < 0.05.

Results

Visual gait analysis

A visual or objective gait analysis was performed in each study condition (free-walk or without orthosis, with Codivilla spring with Toe-Off orthosis and with DAFONS) at time T3 with an analytical acquisition of patient’s gait pattern, reported in table (3).

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Spatio-temporal BTS G-Walk sensor gait analysis

• Objective spatio-temporal data at time T3

A spatio-temporal gait analysis, using the BTS G-Walk sensor device, was performed in each study condition (free-walk or without orthosis, with Codivilla spring, with Toe-Off orthosis and with DAFONS) at time T3 with an analytical acquisition of patient’s raw data (see table 4). An objective intrapersonam spatio-temporal raw data comparison, performed in our 4 study conditions, showed a different trend in each patient recruited. In particular:

- Test duration (sec)(see figure 10)

• all patients showed a decrease of test duration by using DAFONS that cannot be observed in the other study conditions

• patient P1 and P5 (> in P5) showed an increase of test duration compared to patients P2, P3 and P4 by using Toe-Off

Codivilla DAFO Toe-off DAFO DAFONS

Ankle joint assisted NO NO YES

Adjustable device NO NO YES

Defined pivot point NO NO YES

Ankle ROM regulation NO NO YES

Adjustable spring force NO NO YES

High spring force NO YES YES

Soft heel stop NO NO YES

Possible plantar flexion NO NO YES

Table 2. DAFO technical and functional comparative profile (by M.Z. – Il podologo Srl).

Jacobs Publishers 9Table 3

Orthostatic and orthodynamic trunk

attitude

Core stability and hip movement in stance and

swing phase

Knee attitude in stance and swing phase

Global movement attitude of the trunk-hip-lower limb unit

Ankle movement profile in stance and swing

phase

P1 (rl)* Asymmetric (FW)

C = ameliorated TO = worsened NS = normalized

Present with an abnormal up and down and lateral hip tilt in stance

and swing phase (FW)

C = ameliorated with decrease of the abnormal hip ROM TO = worsened NS = normalized

Physiological eccentric right knee control in stance and natural ROM in

swing ipsilaterally (FW)

C = ameliorated TO = worsened NS = normalized

Asymmetric (FW)

C = ameliorated TO = worsened NS = normalized

Persistent varus-supination right ankle attitude during whole gait

cycle with an abnormal and incomplete heel and stance phase control; physiological left ankle

control (overpowered) in stance and swing (FW)

C = fairly good modified TO = worsened NS = normalized

P2 (rl)* Asymmetric (FW)

C = unmodified TO = unmodified NS = normalized

Present with an abnormal “up and down and lateral” hip tilt in stance

and swing phase secondary to a lower limb dysmetry and a related

orthostatic deep disperception (FW)

C = ameliorated with a decrease of the abnormal hip ROM TO = worsened NS = amelioration of the perceptive gait control

Physiological eccentric right knee control in stance and natural ROM in

swing ipsilaterally (FW)

C = ameliorated TO = worsened NS = normalized

Asymmetric (FW)

C = unmodified TO = unmodified NS = normalized

Physiological bilateral ankle attitude in single and double support with an intercurrent

steppage schema on the right lower limb in swing phase (FW)

C = ameliorated with a decrease of the right steppage TO = unmodified NS = normalized

P3 (rl)* Symmetric (FW)

C = fairly good normalized TO = fairly good normalized NS = normalized

Physiological left hip control in stance and swing phase; abnormal increase of the right hip “up and

down” tilt in stance and push-off; core stability present in double

contact (FW)

C = fairly good normalized TO = unmodified NS = normalized

Physiological eccentric right knee control in stance and natural ROM in swing ipsilaterally; intercurrent right knee recurvatum in stance (residual right quadriceps weakness ?!) (FW)

C = fairly good ameliorated TO = fairly good modified NS = normalized

Symmetric (FW)

C = fairly good normalized TO = fairly good normalized NS = normalized

A fairly good hindfoot valgus attitude on the right foot in initial

contact and midstance with a residual physiological gait

excursion in stance and swing phase; prolonged swing phase duration on the right side (FW)

C = fairly good modified TO = worsened NS = normalized

P4 (rl)* Asymmetric (FW)

C = unmodified TO = unmodified NS = unmodified

Abnormal proximal right hip vaulting to compensate the search

of a distal ankle clearence in swing; proximal right hip retroversion secondary to a proximal muscle

weakness and distal knee recurvatum; physiological left hip control in stance and swing phase; core instability during a long way

gait performance (FW)

C = unmodified TO = fairly good modified NS = fairly good normalized

Right knee recurvatum in stance with a physiological left knee control in

double stance (FW)

C = worsened TO = unmodified NS = fairly good modified

Asymmetric (FW)

C = unmodified TO = unmodified NS = fairly good modified

Constant valgus-pronated right ankle attitude in stance with a flat

foot gait schema distally and a related knee recurvatum proximally

during gait (FW)

C = ameliorated TO = unmodified NS = fairly good normalized

P5 (dh)* Asymmetric (FW)

C = unmodified TO = worsened NS = normalized and no care giving need

Abnormal hip antiversion in stance with an evident core instability and

an high care-giving need during gait; a fairly good hip control in

swing phase with a related abnormal up and down and lateral

tilt of it, facilitated by a related knee hyperextension in stance (FW)

C = worsened TO = worsened NS = normalized with an increase of global postural orthostatic and orthodynamic hip and trunk control

With an high care-giving need, abnormal eccentric bilateral knee control in stance secondary to the

proximal hip antiversion, the quadriceps weakness and the constant hyperextension lower limb attitude;

fairly good the dynamic knee attitude in swing phase bilaterally (FW)

C = worsened TO = worsened NS = fairly good normalized the knee hyperextension secondary to the orthotic tibialis pivot remodulation of the orthostatic and orthodynamic limb allignment

Asymmetric with a constant proximal limb adduction and a distal abnormal “scissors limb attitude” during the single and

double lever support of gait

C = worsened TO = worsened NS = normalized, no care giving need, remodulation of a correct orthostatic and ortodynamic trunk-hip and lower limb attitude in stance and swing phase

Constant valgus-pronated ankle attitude in stance bilaterally with a flat foot gait schema distally and a

related knee recurvatum proximally during gait (FW)

C = worsened TO = worsened NS = normalized with a physiological recover of the stance feet control during gait performance (1°-2°-3° rocker)

Table 3. Analytical visual gait analysis report in each study condition for each patient.

*rl = right lateralized; dh = double hemiplegia FW = free-walk condition; C = Codivilla spring condition; TO = Toe-Off orthesis condition; NS = DAFO with Neuroswing joint condition.

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Parameter (Unit)

Paziente [T3] Free walk

Codivilla Toe-Off AFOns

Test duration (sec)

1 44,6 56,9 90 45,1 2 35,9 33,7 34,6 31,9 3 31,4 33,8 33,7 30,8 4 74,1 74,5 74,8 73,7 5 107,7 88,3 150 73,7

Gait speed (m/s)

1 0,99 0,95 0,4 0,8 2 1,4 1,46 1,43 1,46 3 1,55 1,5 1,66 1,73 4 0,97 0,95 1,08 1,02 5 0,77 0,8 0,3 0,92

N° of step cycle on the left side

1 24 32 32 21 2 19 19 19 18 3 14 14 14 13 4 57 54 55 56 5 51 44 43 63

N° of step cycle on the right side

1 23 30 28 21 2 19 19 19 18 3 14 14 14 12 4 58 54 55 57 5 49 45 44 60

Gait cadence (steps/min)

1 103,4 93,4 98,3 91,33 2 119,7 122,2 118,7 122,7 3 108,5 106 107,1 112,2 4 121,6 122,6 126,7 128 5 93,6 89,9 90 109,2

Stride lenght on the right side (% cycle)

1 50,5 45,3 43,5 48,7 2 47,86 51,75 51 53,7 3 46,5 46,8 47,6 46,5 4 52 50,8 50,8 50,6 5 50,1 43,4 42,2 50,5

Stride lenght on the left side (% cycle)

1 49,5 54,7 49,7 51,3 2 52,13 48,25 49 46,3 3 53,5 53,2 52,4 53,5 4 48 49 49,2 49,4 5 49,9 49,8 48,1 49,5

Stance phase duration on the right side (% cycle)

1 57,8 58,5 23,3 55 2 56,23 56,95 53,5 55,3 3 79,7 74,9 78,6 71,9 4 74,9 72,1 81,1 80,1 5 68,8 71,7 71,2 73

Stance phase duration on the left side (% cycle)

1 74,1 78,5 77,7 71,1 2 62,7 64,15 45,5 68 3 75,2 72,2 72,3 69,5 4 56,3 60 62,5 63,3 5 64,6 69,2 70,1 72,5

Swing phase duration on the right side (% cycle)

1 42,2 41,5 40,9 44,9 2 43,76 35,85 46,5 44,5 3 20,3 25,1 21,4 28 4 25,1 27,8 18,9 19,9 5 31,2 28,3 28,1 27

Swing phase duration on the left side (% cycle)

1 25,9 21,5 17,2 28,9 2 37,3 35,85 27,5 32,03 3 24,8 27,8 27,7 30,5 4 43,7 40 37,5 36,7 5 35,4 30,8 33,3 27,5

Double gait support duration on the right side

(% cycle)

1 11,2 20,9 19,1 10,3 2 8,76 11,7 14,95 12 3 21,6 15,4 16,8 12,4 4 11,7 13,3 14,2 14,5 5 18,3 21,1 20,7 21

Double gait support duration on the left side

(% cycle)

1 20,3 15,6 20,2 15,7 2 10,1 9,9 11,85 11,4 3 33,3 31,5 33 30,7 4 19,6 18,7 29,5 20 5 15,2 20,5 21,2 23,3

Table 4. Analytical report of patient’s spatio-temporal raw data.

orthosis that we cannot observe by using Codivilla spring and DAFONS

Figure 10. Test duration trend for each patient in different study conditions.

- Gait speed (m/sec)(see figure 11)

• patients P2, P3 and P4 showed a similar gait speed trend in all study conditions

• a selective increase of gait speed was observed for patient P5 by using DAFONS

Figure 11. Gait speed trend for each patient in each study condition.

- N° of left step cycles

• similar trend in each study condition for patient P2, P3 and P4

• parameter increase by using Codivilla spring and Toe-Off for patient P1 and by using DAFONS for patient P5

- N° of right step cycles

• similar trend in each study condition for patient P2, P3 and P4

• parameter increase by using Codivilla spring and Toe-Off for patient P1 and by using DAFONS for patient P5

- Gait cadence (steps/min)

• similar trend in each study condition for patient P1, P2, P3 and P4

• parameter increase by using DAFONS for patient P5

- Stride lenght on the right side (% cycle lenght)

• similar trend in each study condition for patient P3 and P4

• parameter increase by using DAFONS compared to Codivilla spring and Toe-Off use with a similar trend in free-walk (FW) condition for patient P1,P2 and P5

- Stride lenght on the left side (% cycle lenght)

• parameter increase by using DAFONS compared to Toe-Off use with a similar for patient P1,P3 and P5

• parameter decrease by using DAFONS compared to Codivilla spring and Toe-Off use for patient P2

- Stance phase duration on the right side (% cycle)(see figure 12)

• parameter increase by using DAFONS for patient P1, P2 and P5

• similar trend in each study condition for patient P3 and P4

Figure 12. Stance phase duration trend on the right side for each patient in each study condition.

- Stance phase duration on the left side (% cycle)(see figure 13)

• parameter increase by using DAFONS for patient P2, P4 and P5

• similar trend in each study condition for patient P1 and P3

- Swing phase duration on the right side (% cycle)

• parameter increase by using DAFONS compared to the other

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study conditions for patient P1 and P3

• parameter decrease by using DAFONS compared to Toe-Off use for patient P2 and P5

- Swing phase duration on the left side (% cycle)

Figure 13. Stance phase duration trend on the left side for each patient in each study condition.

• parameter increase by using DAFONS compared to the other study conditions for patient P1 and P3

• parameter decrease by using DAFONS compared to Toe-Off use for patient P2 and P5

s. Double gait support duration on the right side (% cycle)(see figure 14)

• parameter increase by using DAFONS compared to the other study conditions for patient P4 and P5

• parameter decrease by using DAFONS compared to Codivilla spring and Toe-Off use for patient P1 and P3

Figure 14. Double gait support duration trend on the right side for each patient in each study condition.

- Double gait support duration on the left side (% cycle)(see figure 15)

• parameter increase by using DAFONS compared to the other study conditions for patient P4 and P5

• parameter decrease by using DAFONS compared to Codivilla spring and Toe-Off use for patient P1 and P3.

Figure 15. Double gait support duration trend on the right side for each patient in each study condition.

• Comparative analysis of BTS-G walk sensor spatio-temporal data aquired at time T3

For the aim of this study, we used a Friedman non-parametric tests with Wilcoxon post-hoc test to realize six comparative analysis of each patient performance: 1) free-walk or without orthosis vs Codivilla spring; 2) free-walk or without orthosis vs Toe-Off; 3) free-walk vs DAFONS; 4) Codivilla spring vs Toe-Off; 5) Codivilla spring vs DAFONS; 6) Toe-Off vs DAFONS. In line with the non parametric Friedman test (see table 5), we observed at time T3 a statistical significant difference

Table 5. Mean value (+/- DS) of test duration in our 4 study condition (own elaboration).

[Χ2(3)=9; p=0,029] in the test duration (sec) by using Toe-Off orthosis vs DAFONS (76,62 vs 51,04) (Z=-2,023; p<0,05) and by using Codivilla spring vs Toe-Off orthosis (57,44 vs 76,62 (Z=-2,023; p<0,05) (see figure 16). No statistical

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Table 5

Mean value SD

FW

Codivilla

Toe-Off

Neuroswing

58,74

57,44

76,62

51,04

32,02379

24,32135

47,8925

21,4373

significant differences were observed in the comparative BTS spatio-temporal analysis of the other study conditions (FW vs Codivilla, FW vs Toe-Off, FW vs DAFONS and Codivilla vs DAFONS).

Figure 16. Comparative trend of test duration mean value acquired with BTS device in our 4 study conditions with an evidence of statistical significant differences between Toe-Off vs NS and Codivilla spring vs Toe-Off (own elaboration).

Discussion

In the last years, many clinicians and technicians demonstrated the clinicial and rehabilitative usefulness of common AFOs to influence the gait profile of adults and children affected by central or peripheral nervous system damages [10,11]. Few studies tried to perform a comparative analysis and quantitative evaluation of preformed AFOs (Codivilla spring and Toe-Off) and dynamic custom-made AFOs [12,13]. Slijper and al., [7] evaluated the grade of confidence and compliance by walking with a dynamic individualized ankle foot orthosis (DAFO) and a standardized carbon composite ankle foot orthosis (C-AFO) in a cohort of adults affected by hemiparesis due to stroke. The authors of this study [7] demonstrated an higher confidence by using DAFO, resulting in a longer walking distance and faster stair climbing when compared to walking with a C-AFO. In a recent study, Zollo et al., [9] performed a spatio-temporal, kinematic and SEMG gait analysis in a cohort of post-stroke hemiparetic adults comparing the functional value of Codivilla spring versus a Toe-Off orthosis. With surprise, they found no significant differences among these two ankle foot orthosis on spatio-temporal gait parameters and both produced a reduction of the range of motion of the ankle dorsi-plantar flexion during stance with a respect to the gait profile without AFO. Analyzing the postural and SEMG impact of these two type of orthosis, they also observed a reduction of the asymmetrical gait schema between the hemiparetic and the contralateral limb by using these orthosis and an increase of the co-contraction of the couples of muscles involved in the gait schema by using the Codivilla spring.

With respect to these obervations, we proposed an original investigational study with the purpose to perform a comparative spatio-temporal gait evaluation of a non-jointed AFO versus an innovative dynamic jointed Ankle-Foot-Orthoses coupled with the so-called Neuroswing (DAFONS) on patients affected by different neurological gait schema. In line with the spatio-temporal BTS raw data, we demonstrated in each study condition a selective amelioration of our patient’s gait performance by using DAFONS compared to the use of Codivilla spring and Toe-Off orthosis: a. all patients showed a decrease of test duration by using DAFONS that cannot be observed in the other study conditions; b. a selective increase of gait speed was observed for patient P5 by using DAFONS; c. a selective increase of gait cadence was defined by using DAFONS in patient P5; d. an increase of the n° of left and right step cycles was observed by using Codivilla spring and Toe-Off for patient P1 and by using DAFONS for patient P5; e. we defined an increase of the stride lenght on the right and left lower limb by using DAFONS compared to Codivilla spring and Toe-Off use with a similar trend in free-walk (FW) condition for patient P1,P2 and P5; f. an increase of stance phase duration on the right and left body side was defined using DAFONS for patient P1, P2 and P5; g. a decrease of the swing phase duration on the right and left side was observed by using DAFONS compared to the other study conditions for patient P1 and P3 with a parallel decrease of it by using DAFONS compared to Toe-Off use for patient P2 and P5; h. an increase of the double gait support duration on the right and left side was defined by using DAFONS compared to the other study conditions for patient P4 and P5 with a parallel decrease of this parameter by using DAFONS compared to Codivilla spring and Toe-Off use for patient P1 and P3. An analytical evaluation of our spatio-temporal raw data demonstrated the functional efficacy of our dynamic jointed and custom-made ankle foot orthosis but this trend was not uniform in all patients recruited. Different pathological and asimmetrical gait schema required individualized biomechanical joint calibration for each patient with an inevitable different gait response. Moreover, the raw spatio-temporal data defined a stronger similar functional response by using Toe-Off orthosis and DAFONS compared to Codivilla spring use. We are convinced that related to patient’s pathological gait schema, physician’s requirements and the rehabilitative goals, orthotists must produce an orthosis that, designed with an ankle joint system with preloaded disc springs, we can store the energy brought in by the body weight during gait and produce tuning effect on patient’s gait and sense of balance. Using the right modern materials (carbon, kevlar and other synthetics of hardness grades) and material properties in the right place, we realized an orthosis with surprisingly more functions than one would suspect at first. We observed during the last 3 years of our clinical experience in the Clinical Institute of Città di Brescia and with the priority support of our orthotist, that correcting static alignment and function of ankle joint by using a new concept of dynamic mechanical ankle joint system called

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Neuroswing we can influence and modulate the knee joint and the static and dynamic postural stability of selected patients with neurologcial gait pattern. Personalization of esoscheletal design, plurimodulation of the ankle biomechanical properties, task and function specific regulation of the dynamic lever spring force with an optimization and storage of the energy brought in by the body weight which supports in this way ankle’s push-off when released and controls the step lenght on the affected and unaffected limb, defined the uniqueness of our DAFONS that we didn’t fined in other orthotic devices.

To investigate the functional impact of our DAFONS vs other not-jointed DAFO considered in this study, we also developed a comparative analysis of our spatio-temporal data aquired at time T3 using a Friedman non-parametric tests with Wilcoxon post-hoc test to realize six comparative analysis of each patient performance. We observed at time T3 a statistical significant difference in the test duration by using Toe-Off orthosis vs DAFONS and by using Codivilla spring vs Toe-Off orthosis that cannot be observed in the other study conditions. This data demonstrated that DAFONS, realizing an orthostatic stability first at all, can increase patient’s sense of balance and core stability with a secondary increase of gait velocity, gait cadence and a remodulation of stance and swing phase control that produce an inevitable decrease of our BTS test duration that cannot be observed by using Toe-Off and Codivilla spring. Using a simple video off-line revalutation of our patient’s gait schema in each study condition defined (Visual Gait Analysis), we could analyze the specific maladaptive and adaptive functional effect derived from the use of the three types of orthesis considered in this study. Unsurprised, we noted an amelioration of gait quality with the use of DAFONS in all those patients (P1, P3 and P5) who showed a neurocognitive competence with a related functional grade of neurorehabilitative re-learning attitude of the physiological gait pattern and with a compromised perceptive control of gait and core stability.

Conclusion

DAFONS can be considered as an individualized peripheral neuro-facilitation of gait cycle (peripheral perceptive facilitation), a neurorehabilitative re-learning device of physiological gait pattern (peripheral assisted neuroplasticity facilitation) and a device that can increase patient’s motor abilities and quality of life in his personal milieu. For this reason, DAFONS can only be relized by orthotics who are able to combine own technical attitudes with a specific neurofunctional and neurorehabilitative clinical knowledge, defining as their working goal the uniquiness of a multidisciplinary collaboration. Further studies are going on to increase the cohort of patients of our study with the introduction of a related telemetric SEMG analysis for evaluating the specific effect of DAFONS, compared with SAFOs or FRAFOs, on the muscle recruitment EMG gait pattern.

References

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