Otto Bock Neurostimulation
1
www.ottobock.com
ActiGait®
Implantable drop foot stimulator
FES Education DayUniversity Hospital, Coventry
25 November 2010
2© Otto Bock HealthCare
Contents
�Company background
�ActiGait®
� Indications
� product description
�Clinical evidence
� Patient videos
� Patient testimonials
�Functional Electrotherapy – STIWELL med4
�Live demonstration
3© Otto Bock HealthCare
Otto Bock: Who are we?
• Started 1919
• 4218 employees, 40 direct rep, 140 countries
• €30m annually for research and development
Prof. H.G. Näder,
Owner and CEO
Family business in 3rd
generation
Otto Bock Foundation
Otto Bock Science Centre for Medical
Technology, BerlinOtto Bock Academy
Headquarters
Duderstadt, Germany
4© Otto Bock HealthCare
Otto Bock UK: Who are we?
� Headquarters in Egham, Surrey
� 27 years
� Clinical service, production, sales, education and training
�4 divisions: Neurostimulation, Prosthetics, Orthotics, and
Mobility
Orthotic Service Fabrication,
Birmingham
Special Seating
Leeds
UK HQ
Egham offices
5© Otto Bock HealthCare
� Upper extremities
� Lower extremities
� Socket Technologies
� Materials
� Osseointegration
� Modular orthoticsystems
� Braces and Support
� Materials
� Continuous Passive Motion
� Rehband Sport
� Manual wheelchairs
� Powered wheelchairs
� Pediatrics
� Seating & positioning
� Premium Products
Orthobionic®
� FES-Therapy
� Neuroimplants(ActiGait)
Bionicmobility®
Prosthetics OrthoticsMobility
SolutionsNeurostimulation
Strategic Business Segments
� QM – Code of Practice
� Financing Solutions
� Service Fabrication
� Planning & Equipping
� Customized Care
� Otto Bock AcademyBusiness
Services
Business
Services
Patient CarePatient Care Otto Bock Competence Centre and Clinical CentreOtto Bock Competence Centre and Clinical Centre
� IT-systems integration
One company taking each step to recovery with our customer One company taking each step to recovery with our customer
What we cover �What we cover �
6© Otto Bock HealthCare
Patient Flow
Stages
Function
ActiveActive ImplantsImplants
OrthoticsOrthotics
FES / FET
ActiGait®ActiGait®
NeuroStep®NeuroStep®
Walk On®
Neurexa
Line
„STIWELL med4“„STIWELL med4“
MotorMotor RehabilitationRehabilitation afterafter StrokeStroke
Otto Bock Neurostimulation
2
7© Otto Bock HealthCare
Neurostimulation
www.sbg.ac.at
8© Otto Bock HealthCare
Neurostimulation
• Functional Electrical Stimulation
FES
ActiGait®
• Functional Electro Therapy
FET
STIWELL med4
www.ottobock.com
ActiGait®
Product Description
10© Otto Bock HealthCare
ActiGait® implantable drop foot stimulator
External control unit
External antenna
Implanted receiver
Implanted electrode
Heel switch
11© Otto Bock HealthCare
ActiGait® - history & current status
� 1999: First prototypes implanted in
Denmark (Neurodan, Aalborg)
� 2003: Evaluation trial (15 patients
in 3 rehabilitation centres in
Denmark)
� September 2006: CE marking
� ~50 patients in Europe: Germany,
Netherlands, Denmark, Austria,
Luxemburg
� 2010: UK launch
12© Otto Bock HealthCare
ActiGait® - general description & indications
� Stroke patients
� Mobile patient where drop foot is the main problem with gait
� To improve gait (speed, endurance, symmetry)
� Aid patient’s subjective perception of independence, safety, and confidence in walking
� Solution for patients unable to use surface FES (for example due to skin reactions or sensitivity)
� Avoids problems of surface electrode positioning
� Easy to use and cosmetic solution
Otto Bock Neurostimulation
3
13© Otto Bock HealthCare
ActiGait – Indications
� be fully grown-up
� have a single-sided hemiparesis due to a cerebro-vascular accident
� have a passive range of movement of the affected ankle joint of at
least 30 degree
� be able to stand upright with both heels touching the floor while hips
and knees are in neutral position (without the need of an AFO for
stance control)
� have a reduced speed of walking
� be able to walk 20 meters in less than 2 minutes with or without
walking aid but without the help of another person
Patients must
14© Otto Bock HealthCare
ActiGait – Indications (continued)
have a positive response to surface electrical stimulation of the peroneal nerve – i.e. muscle contraction results in ankle dorsiflexion and improved gait
� Clinical point of view
� Patient point of view
Patients must
15© Otto Bock HealthCare
ActiGait - Contra indications
� peripheral nerve damage in the affected lower extremity
� severe or uncontrolled diabetes mellitus or other diagnosis with
peripheral nerve involvement
� poor skin condition on the affected lower extremity
� a subcutaneous layer of fat on the thigh of more than 3,5 cm
� poorly controlled epilepsy
� inability to walk 100 m without stopping prior to CVA (with or without a
walking aid, but without the help of another person)
Patients having:
16© Otto Bock HealthCare
ActiGait - Contra indications (continued)
� other active neuro-implants such as defibrillators and demand pacemakers
� concomitant medical and psychological conditions which would limit the success of the ActiGait® system
� concomitant medical and psychological conditions which would compromise the safety of the patient in connection with the implantation or use of the ActiGait® system
Patients having:
17© Otto Bock HealthCare
ActiGait - External Components
Control unit
Heel switch
Antenna
Antenna fixation
18© Otto Bock HealthCare
ActiGait - Control Unit and Antenna
1. Control unit housing
2. Antenna
3. Belt clip
4. Display
5. Power switch
6. ‘Intensity Up’ button
7. ‘Intensity Down’ button
8. Charger socket
9. Charger indicator
10. Clinician interface
� Worn on waist and
held by belt clip
123 g; 120x15x45 mm
� Pulse width control
for all channels jointly
� Data logging
number of steps at
each intensity level
� Rechargeable
battery
8-16 hrs (10,000 steps
or 16 hrs depends on
activity); charge time
3.6 hrs
Otto Bock Neurostimulation
4
19© Otto Bock HealthCare
ActiGait - Control Unit display
1. Control Unit Battery Level indicator
2. Stimulation Intensity indicator
3. Stimulator Active indicator
4. Heel switch Battery indicator
Low battery Control unit
Low battery Heel switch
20© Otto Bock HealthCare
ActiGait - Heel switch
1: Housing with battery and radio transmitter
2: Sensor
3: Heel switch sock
� Wireless link to control unit
� Dimensions: 16.7 × 2 cm
� Mass: 22 g (including battery)
� Battery: lithium coin cell type CR2032
� Transmitting range: 2 m
� Life is 4 months @ 8000 steps/day
� Can be used under affected or non-affected side
� Heel switch socks allow use without wearing shoes
3
21© Otto Bock HealthCare
ActiGait - Antenna fixture
� Small hypoallergenic plastic disc
� Attached to the thigh skin surface right above the implanted stimulator
� Clicks onto the inside of the antenna to hold it in place
� Designed to attach to the skin for up to several weeks
� Replace when it loosens enough to be pulled off easily
22© Otto Bock HealthCare
ActiGait - The Implant
Stimulator body
cuff-electrode Sutures
23© Otto Bock HealthCare
� 1 silicone cuff electrode placed around the common peroneal nerve proximal to knee joint
� 22 mm long with 12 platinum/iridium contact discs located on the inside.
� 4 channels (interleaved)
� 5 cuff sizes
� Stimulator body implanted in lateral thigh
� Wireless link between antenna coil & stimulator body
� 15 g; 60 x 30 x 6 mm stimulator body; cable length 25 cm
� 10 years lifetime
ActiGait - The Implant
24© Otto Bock HealthCare
� 1 silicone cuff electrode placed around the common peroneal nerve proximal to knee joint
� 22 mm long with 12 platinum/iridium contact discs located on the inside.
� 4 channels (interleaved)
� 5 cuff sizes
� Stimulator body implanted in lateral thigh
� Wireless link between antenna coil & stimulator body
� 15 g; 60 x 30 x 6 mm stimulator body; cable length 25 cm
� 10 years lifetime
ActiGait - The Implant
Otto Bock Neurostimulation
5
25© Otto Bock HealthCare
ActiGait - Surgery
A B C
26© Otto Bock HealthCare
ActiGait - Technical Data
Fixed Settings:
• Pulse shape: Asymmetric bipolar; charge
balanced - exponential discharge (capacitive) for passive phase
• Current amplitude: 1.2 mA
Adjustable Settings:
• Pulse duration: 0 – 300 µs
• Stimulation frequency: 5 – 50 Hz
• Number of active channels: 1 – 4 channels
• Stimulation profile according to heel lift and heel strike
• Position of heel switch on affected or non-affected leg.
27© Otto Bock HealthCare
ActiGait - Activation and device setup
2-3 weeks after surgery;
depends on wound healing.
28© Otto Bock HealthCare
ActiGait - Clinical Station software
� Programming stimulator settings
� Patient database; store all patient settings, such as demographic data, previous sessions settings etc.
� Flexible setting of FES timing and parameters
29© Otto Bock HealthCare
� Flexible setting of FES timing parameters
� Delay 0 – 2 s
� Extension 0 – 2 s
� Ramp up 0 – 2 s
� Ramp down 0 – 2 s
� Intensity can be controlled to increase at heel contact above swing phase stimulation level and before ramp down
ActiGait - Clinical Station Software
30© Otto Bock HealthCare
� Flexible setting of FES parameters
� Number of adjustment steps for patient control of intensity
� Stimulation frequency 5 – 50 Hz
� Heel switch can be used under affected or non-affected side
� Exercise mode (software control on intensity, on/off duration)
ActiGait - Clinical Station Software
Otto Bock Neurostimulation
6
31© Otto Bock HealthCare
� software control for the range & step value change for each channel individually:
� Maximum stimulation
� Minimum stimulation
� Maximum stimulation set by patient
� Normal stimulation
� Minimum stimulation set by patient
� Any combination of the 4 channels can be activated
� 0 – 300 microsec in steps of 0.3 microsec
ActiGait - Clinical Station Software
32© Otto Bock HealthCare
ActiGait implantable drop foot stimulator
www.ottobock.com
ActiGait®
Clinical evidence
34© Otto Bock HealthCare
Functional Electrical Stimulation for drop foot
Liberson et al. 1961
35© Otto Bock HealthCare
• Objectives:
• To evaluate safety, performance, efficacy and subject satisfaction of the ActiGait® dropfoot stimulator system
• Study design:
• Prospective , non-randomised, open label multicenter study, repeated measures over a period of 90 days, 15 months follow-up
• Participants:
• 15 hemiplegic subjects with drop foot, at least 6 months after stroke
• Settings:
• Three Danish Clinical Centres
Danish ActiGait® Clinical Trial
36© Otto Bock HealthCare
Danish ActiGait® Clinical Trial
Otto Bock Neurostimulation
7
37© Otto Bock HealthCare
• Efficacy:
• Statistically significant increase in walking distance and maximal gait speed
• 14 % increase in distance walked in 4 minutes
• 20 % increase in gait speed
Max self-selected gait
speed (m/s)
Distance walked in 4 min
(m)
20%����0,0080.10
14%����0,02816,23
PMean difference
•paired samples t-test, 15 month – baseline (n=13)
Burridge et al.: J. Rehab Medicine 2007, 39;212-218
Danish ActiGait® Clinical Trial
38© Otto Bock HealthCareActiGait® Course
Walking distance and max. speed
Baseline 15 months
(n = 13) NS NS S
Distance
walked (m)
mean (SD)
min to max
126.6 (41.9)
60 to 184
131.4 (51.5)
43 to 203
142.9 (49.3)
59 to 199
Max speed
(m/s)
mean (SD)
min to max
0.55 (0.18)
0.25 to 0.74
0.58 (0.23)
0.18 to 0.87
0.66 (0.22)
0.25 to 0.87
Burridge et al.: J. Rehab Medicine 2007, 39;212-218
van de Port et al.: J. Rehab Medicine 2008, 40;23-27
Support transition from non- or limited community walker
to confident community ambulation
39© Otto Bock HealthCare
ActiGait® Clinical Trial – Patient perceptions
Safety
Confidence
Independence
When I use ActiGait® I am
less likely to trip or fall
more confident in walking
more independent
Strongly agree I agree I disagree Strongly disagree
40© Otto Bock HealthCareActiGait® Course
Subject Satisfaction Questionnaire
How often do you use the system?
41© Otto Bock HealthCareActiGait® Course
Subject Satisfaction Questionnaire cont.
When I use ActiGait® I feel more confident in walking
42© Otto Bock HealthCareActiGait® Course
Subject Satisfaction Questionnaire cont.
I prefer to use the ActiGait® to a splint
Otto Bock Neurostimulation
8
43© Otto Bock HealthCareActiGait® Course
Subject Satisfaction Questionnaire cont.
Do you need help to put the ActiGait® on?
www.ottobock.com
ActiGait®
Patient videos
45© Otto Bock HealthCare
• Male aged 55
• CVA 2003
• Right side effected
• Weak activity m. tibialis anterior, none activity m. peronaeus
• Ashworth scale
hamstring muscle group 0
quadriceps muscle group 0
calf muscle group 1
Patient K.P.
46© Otto Bock HealthCare
No stimulation ActiGait
Patient videos – Patient K.P.
• conventional therapy was not successful, the splint generated spasticity in the toes
• “since using the system I have less back pain”
• K.P. is surprised that he is not any longer stumbling when the system is off
47© Otto Bock HealthCare
Patient videos - TM
Without stimulation With stimulation
ActiGait OFF ActiGait ON
48© Otto Bock HealthCare
Patient testimonials
� ‘It has become easier to go shopping and handle daily living’
� ‘I can change shoes faster, walk without shoes and wear sandals’
� ‘My legs are warmer; now I seldom get cramps’
� ‘I don’t care how I walk, but now I can sleep during the night
because my cramps have almost gone’
� ‘I am more motivated for going out – I have been travelling’
� ‘My nose is not pointing downwards any longer’
Otto Bock Neurostimulation
9
49© Otto Bock HealthCare
Neurostimulation
• Functional Electro Therapy
FET
STIWELL med4
• Functional Electrical Stimulation
FES
ActiGait®
50© Otto Bock HealthCare
STIWELL med4 – functional electrotherapy
• 4 stimulation channels
• 2 EMG measurement channels
• EMG-triggered stimulation
• Programmable
• Biofeedback
• Memory for storing treatment data
• Training of coordination, inhibition, myosymmetry
• muscle relaxation
• PC games for biofeedback
• Denervated muscle stimulation
51© Otto Bock HealthCare
STIWELL med4 programs
• Muscle Strenghthening
• Denervated Muscles
• Feedback Programs
• Feedback Display Games
• Feedback PC-Games
• Pain Therapy TENS
• Urology
• Functional Programs
• Sports
• Mid-Frequency
• Individual Programs
52© Otto Bock HealthCare
STIWELL med4
• Muscle strengthening
• Maintaining or improving joint mobility
• Functional task-oriented training
• Increasing blood supply
• Muscle relaxation
• Pain therapy (TENS)
• Re-establishment of movement patterns
With the following indications:� Disease or injury of the CNS/spinal cord (stroke, SCI, incomplete paraplegia)
� Peripheral nerve lesions capable of regeneration
� Neuro-orthopedic functional disorders
� And for additional muscle training and regeneration in sports
Intended Use & Indications
www.ottobock.com© Otto Bock HealthCare
Live demonstration session
www.ottobock.com© Otto Bock HealthCare
Thank you for listening - Any questions?Salim Ghoussayni PhDBusiness Development Manager – Neurostimulation
32, Parsonage Road, Englefield Green, Egham, Surrey. TW20 0LD+44 (0) 1784 744 900 +44 (0) 7969 586550