Volume 70, Number 1 (Suppl.)Printed in the U.S.A.

(ISSN 0148-9I6X)

INTERNATIONAL JOURNAL OF LEPROSY

Prevention of Disabilities and Rehabilitation

1. IntroductionLeprosy results in a wide range of im-

pairments, the most important of which isdamage to peripheral nerves. Damage toperipheral nerves causes loss of sensory,motor and autonomic nerve function to theaffected region, leading in turn to defor-mity, secondary deformity resulting fromrepeated trauma to as well as dryness andcracking of the skin, and inability to per-form important activities of daily living.These consequences of nerve damage havean impact on the quality of life of those af-fected by the disease and also generatestigma. Societal attitudes towards those af-fected by leprosy, often based on religious,traditional and cultural beliefs, may limitparticipation of people affected by leprosyin their own communities. Prevention ofimpairment is therefore a high priority inthe management of leprosy. Prevention ofnerve damage and the management of im-pairments are important components of anyleprosy program. Rehabilitation in leprosyshould be fully integrated within existingcommunity-based rehabilitation programson an equal basis as those with disabilitiesdue to other causes.

1.1 Prevention of DisabilityApproaches to prevention and treatment

of nerve damage, as well as to limiting sec-ondary effects, such as the increasing defor-mity caused by trauma, are now a standardpart of all leprosy programs. Guidance onthe prevention of impairments and manage-ment of nerve damage is included in pub-lications from the World Health Organiza-tion (I' 2) and ILEP (3-'), and in most na-tional guidelines on leprosy control. Thecomponents of prevention of impairmentsin leprosy programs include measurementof impairment, detection and treatment ofreactions, self-care, footwear and eye-care.The most commonly used measurement ofimpairments is the WHO Disability Index(6), which has been in use for severaldecades. It is robust and simple to use as anindicator of early case-detection. However,it is not responsive to change over time, and

has limited value in monitoring the progressof individual patients. Ball-point pens arefrequently used in the field by health work-ers to assess sensation. Other approaches toassessment of nerve function, based on vol-untary motor testing (7) and sensory testingusing monofilaments (8), are more appropri-ate for monitoring the progress of individ-ual patients. Most guidelines describe howto detect and treat reactions.

Detection of reactions is based on acutechanges of the skin lesions and deteriorationof nerve function; reactions are treated byfixed-dose steroid regimens. Self-care rou-tines are taught, and patients are empoweredto develop daily routines for inspection oflimbs with sensory and motor impairmentfor signs of injury or infection, treatment ofinjuries, active and passive exercises to pre-vention joint stiffness, and soaking and oil-ing to minimize drying of the skin. Instruc-tion on protective clothing, adapted tools,and the use of footwear is also provided.Recommendations on footwear are pro-vided, aimed usually at individuals withsensory impairment of the plantar surface ofthe foot. Earlier documents stressed the de-sign and characteristics of specializedfootwear with cushioned insoles; however,more recent recommendations are for cheap,available and locally acceptable footwear.The sensory and motor impairments that af-fect the eyes, combined with the inflamma-tory processes of iridocyclytis, render theeye potentially vulnerable in leprosy. Exam-ination of the eyes is recommended, as wellas protection and lubrication.

1.2 RehabilitationSurgery plays an important role in the

correction of deformities and in recon-structive procedures to improve function.Surgical correction of foot-drop and lag-ophthalmos can prevent secondary impair-ments such as ulceration and deformity ofthe foot and corneal scarring. Case-selec-tion for reconstructive surgery is very im-portant. Physiotherapy support is essentialboth pre- and post-surgery, as are facilitiesfor occupational retraining. In the past, re-

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S40 International Journal of Leprosy 2002

habilitation in leprosy has tended to bephysically oriented and isolated from gen-eral and community-based approaches torehabilitation. This is now changing, asmore integrated approaches are adopted,and better linkages to existing community-based and community-oriented rehabilita-tion are established. More recently, socialand economic rehabilitation have been ad-vocated.

2. The Evidence-basis for Prevention ofImpairments and Rehabilitation

Guidelines for preventing and managingnerve function impairments (NFI) and forrehabilitation have been based largely onthe experiences of individuals and pro-grams. This section focuses on a systematicreview and critical appraisal of the evidencefor the effectiveness of specific aspects ofprevention and treatment of impairments,and rehabilitation. The following four keyquestions, which were selected by discus-sion within the organizing group and byconsultation with those in the field, areidentified as priorities:

• Is early detection of leprosy, followed byprompt initiation of MDT, effective inprevention of impairments?

• Does early detection and treatment of re-actions and new nerve damage preventimpairments? If so, what are the bestmethods of detection and the thresholdsfor treatment?

• Does steroid prophylaxis prevent impair-ment?

• How effective are interventions in self-care, provision of footwear and socio-economic rehabilitation?

2.1 Is early detection of leprosy, followedby prompt initiation of MDT, effective inprevention of impairments?

Many publications assume that early di-agnosis of leprosy and treatment with effec-tive chemotherapy will prevent nerve dam-age (9 That early diagnosis of leprosy,prior to the development of NFI, and treat-ment with effective chemotherapy that in-terrupts the disease process prevents nervedamage appears plausible. However, theprocess of nerve involvement in leprosymay commence long before the disease isclinically manifest. Moreover, NF1 occurs

before diagnosis, during MDT and aftercompletion of MDT (U. 12

), either as a grad-

ual process or as part of a reactionalepisode. Therefore, it is important to ap-praise critically the evidence that early de-tection and MDT is effective in preventingNFI, and to estimate the magnitude of suchan effect.

The evidence may be based only on ob-servational data, because it would be uneth-ical to withhold effective chemotherapy in acontrolled study of intervention. Trials ofchemotherapy regimens could provide anopportunity to examine possible differencesof impact on nerve function; regimens thatinclude clofazimine may result in fewerepisodes of reaction. To date, however, fewchemotherapy trials have included nervefunction as an outcome. Current trials mayinclude nerve function as an outcome, butany difference of effect is likely to be small,compared to the differences between treat-ment and untreated control groups. It is im-portant that trials of different chemothera-pies for leprosy include nerve function asan outcome.

Observational data on the occurrence ofNFI before, during and after MDT havebeen used to estimate the magnitude of thepotential effect of early diagnosis and MDTon NFI. Using such data, a study in Ban-gladesh (12) estimated that early detectionand initiation of MDT could prevent morethan three quarters of impairments, whereasefforts to prevent disability employed dur-ing and after MDT could prevent only onequarter. This estimate is based on a numberof assumptions regarding the effectivenessof MDT and the frequency of impairmentsexpected in untreated leprosy. Nevertheless,the study provided an estimate of the mag-nitude of the effect, and demonstrated that itmay not be possible to prevent all impair-ments by MDT. Failure to achieve early de-tection limits the potential of MDT to pre-vent NFI.

In Ethiopia, it was shown (I') that, as lateas 10 years after MDT, one-third of patientsnever developed impairments. However,this study, which was conducted among agroup of MDT-treated patients, of whom55% were found to have impairments at di-agnosis, raises the question of whether allpatients would develop NFI if left un-treated. There were 39 episodes of neuropa-

70, 1 (Suppl.) Prevention of Disabilities and Rehabilitation S41

thy per 100 person years in the first yearafter commencing MDT in this AMFEScohort (") • In the BANDS cohort inBangladesh 2.6% of PB cases and 37% ofMB cases developed new nerve functionimpairment in the 2 years following detec-tion and MDT treatment (15). A series of es-timates (16) of the potential impact of imple-menting MDT on disability in leprosy havebeen attempted, based on a number of as-sumptions.

Recommendations.

• Early diagnosis of leprosy and treatmentwith MDT are recommended to reducethe frequency of NFI. This recommenda-tion is supported by observational studiesand estimates, and on a number of as-sumptions (such as that untreated caseswould develop NFI).

• It should be noted, however, that MDTwill not prevent all NFI, and that themagnitude of the impact is dependent on"early" case-detection and treatment.

• Nerve function should be included as anoutcome measure in trials of leprosychemotherapy.

2.2 Does early detection and treatmentof reactions and new nerve damageprevent impairments? If so, what are thebest methods of detection and thethresholds for treatment?

A recent review suggests that, overall, 60per cent of patients treated with steroids re-gain nerve function (17), and a number ofstudies that assess the effectiveness ofsteroids in terms of recovery in NFI showrecovery rates of a similar magnitude (18-20).

Surgical inventions such as nerve decom-pression have been considered. Two trialsof steroids vs. steroids plus surgical nervedecompression showed no added benefit ofsurgical intervention (21,22) in terms of nervefunction. Larger, well-designed, controlledstudies of early surgical interventions areindicated.

Defining early detection is difficult:"early" may be considered in terms of theduration of the history of symptoms andsigns. However, studies also consider theseverity of the presenting signs and symp-toms in terms of the magnitude of thechange of nerve function. A study in Nepal,based on a retrospective cohort design,

demonstrated the outcome to be related tothe severity of nerve damage at diagnosis,which may itself be related to timeliness ofdetection (19). A pilot study demonstratedbenefit from steroid therapy even when ad-ministered 6 months after onset of NFIAn important controlled trial that addressesearly detection using monofilaments as partof the TRIPOD trials (24), showed that de-tection of early change in nerve function bymonofilaments did not result in any addi-tional benefit over detection based on care-ful use of a ball-point pen to assess sensorychange.

2.2.1 Methods of early detection. Theneed for early detection and the develop-ment of more sensitive diagnostic methodsfor early detection of neuritis has been rec-ognized (25). Because of a lack of consensuson the best methods, a study was conductedto assess five different methods (26): twoweights of monofilaments, pinprick, tem-perature sensation, and palpation of nervethickness. The study reported that the twobest methods were palpation of nerve thick-ening and the 0.2 mg monofilament.

Predicting NFI and reactions is anotherapproach to early detection. A review of theliterature on type 1 reaction identified asrisk factors BCG, pregnancy, and MDT (27).The review also attempted to estimate theproportion of disability that may be pre-vented by early detection and treatment ofreactions. Facial skin lesions have also beenidentified as a potential risk factor for facialnerve damage, carrying almost a ten-foldgreater risk (28). Previous nerve damage andMB classification were found to be verystrong predictors of nerve damage and reac-tions in a large cohort study in Bangladesh,which suggested a prediction rule that couldbe used in the field (15). Analysis from theAMFES (") cohort in Ethiopia suggestedthat nerve function should be assessed bystandardized methods every month.

Serological tests have also been proposedas a method of predicting nerve damageand reactions. Anti PGL-I antibodies werenot found to be predictive (30), whereasserum levels of neopterin may be an indica-tor ( 3 1). This possibility must be tested inlarge, prospective studies.

2.2.2 Threshold for treatment. Thethreshold for commencing steroid therapyin early reactions or NFI may be based on

S42 International Journal of Leprosy 2002

the magnitude of the change of function orthe duration of the change. NFI is not al-ways associated with skin signs or symp-toms of neuritis, such as pain or tingling inso-called silent neuropathy (32). Thus, re-liance on symptoms and self-reporting isnot sufficient. It must also be recognizedthat there is a degree of variation of nervefunction assessment among methods andamong observers using the same methods(8. 33). A threshold for treatment based onchange of nerve function must be higherthan the expected variation in nerve func-tion assessment.

Recommendations.

• Steroids are recommended to treat reac-tions and nerve function impairments ofrecent onset; the expected recovery ratefor nerve function is approximately 60%.

• MB patients and those with existingnerve function impairments should becarefully monitored for new nerve func-tion loss, as they are the groups at great-est risk.

• Assessment of nerve function using stan-dard methods every month during MDTis recommended.

• Research is recommended to identify theoptimal steroid regimen, to develop alter-native and more effective treatments forreactions and recent nerve function loss,and to determine nerve function changethresholds for treatment.

2.3 Does steroid prophylaxis preventimpairment?

Steroids represent the accepted method(19) of medically treating NFI and reactionsin leprosy. However, would steroids, ifgiven prophylactically along with MDT,prevent NFI and reactions (34)? A number ofstudies that have investigated this questionhave recently been reviewed

The results of two trials of steroid pro-phylaxis have been published. A small (150participants) randomized trial, conducted inIndia and reported (36) in 1985, showed that10 mg of a steroid administered daily alongwith chemotherapy for one month was ef-fective in preventing nerve damage in PBpatients. The second, an open controlledtrial conducted in Bangladesh (35), alsoshowed a significant beneficial effect of 20mg prednisolone daily for 3 months. Both

studies suggest that such an interventionmay prevent NFI and reactions.

A large scale, double-blind trial of low-dose prophylactic steroids, has beenconducted in Bangladesh and Nepal (24.37).The dosage of prednisolone, 20 mg dailyfor the first three months, was tapered dur-ing the fourth month. Patients with previ-ously untreated MB leprosy were randomlyallocated to steroids or placebo along withMDT. The preliminary report ( 3 8) of the re-sults of this trial, presented at the ILA Con-gress in Agra in 2000, confirmed a signifi-cant beneficial effect at 4 months, but theeffect at 12 months follow-up was nolonger statistically significant.

Recommendations. Further research isrecommended on the use of prophylacticsteroids in preventing NFI. It is not onlyimportant to demonstrate, by means of arandomized, double-blind controlled trial,that steroid prophylaxis is effective in pre-venting nerve damage, but also that thebenefits outweigh the costs, includingthose of adverse reactions to steroids. Theresults of the trial should also indicate themagnitude of the effect, and whether theeffect varies among identifiable sub-groups.

2.4 How effective are interventions inself-care and provision of footwear?

Interventions to promote self-care amongpeople with NFL, to provide protectivefootwear, and to stimulate socio-economicrehabilitation have become standard partsof leprosy programs over the last fewdecades. This section provides a review ofthe evidence for the effectiveness of each ofthese components. In practice, the compo-nents are usually delivered in an integratedmanner. Some of the evidence addressessingle components, whereas other evidenceevaluates the effectiveness of packages ofinterventions.

2.4.1 Self-care. Self-care is the manage-ment, on a daily basis, of the effects ofnerve function impairment, and is the re-sponsibility of the individual. Many papersdescribe self-care, but do not evaluate itseffectiveness. The role of health-care work-ers is to educate and enable patients in theself-care process. A major survey (4) of self-care activities in ILEP- supported projects

70, 1 (Suppl.) Prevention of Disabilities and Rehabilitation S43

in 1995 revealed that 90 per cent or more ofprojects train patients in self-care and giveadvice on footwear.

Four papers that evaluate self-care and anadditional five that evaluate self-care andfootwear together have been identified.Seven of these studies are based on before-and-after study designs, and two employ acomparison group. The four studies thatevaluate only the self-care component arethe following. First, a study conducted inIndia (39) demonstrated that a self-careintervention for a period of 4 months im-proved the quality of the skin, and consider-ably reduced both hand and plantar ulcera-tion. The second study, a before-and-afterstudy also conducted in India (40), showedphysical, functional and social improve-ment after self-care, as assessed by thepatients themselves. The third study, a con-trolled trial in which two different ap-proaches (patient education and communityeducation) to self-care were compared to acontrol group (4'), also demonstrated bene-fit. Conducted in Nepal, the fourth study(42), which was a comparative trial of a 14-day self-care training program, showed thatthose trained were significantly less likelyto be admitted for an infected plantar ulcerthan were the controls. Each of these fourstudies showed benefit from self-care; thetwo comparative trials, in which the two in-terventions were compared to a controlgroup, provided more robust evidence.

2.4.2 Footwear. The importance of ap-propriate footwear for feet lacking plantarsensation was recognized in the 1950s and1960s. The use of adapted and modifiedfootwear, using both molded shoes and in-soles cushioned with micro-cellular rubber,was advocated. However, this approachwas criticized because such footwear is dif-ficult to produce and because of stigma(43—'5). Treatment centers were unable toproduce sufficient shoes for those whoneeded footwear, and, because the shoeswere fragile, to repair and to replace them.Also, because the shoes were also obvi-ously different from that worn by the rest ofthe community, they became a symbol ofthe disease. During the last decade, this ap-proach has been superseded by one of en-couraging appropriate, locally acceptablefootwear.

Three studies evaluate footwear pro-

grams, five evaluate combined programs ofself-care and footwear, and one evaluatesfootwear and socio-economic rehabilita-tion. The first study, a before-and-after in-vestigation of footwear, was conducted inEthiopia (46). The second, a trial of foot or-thoses in India (42), demonstrated a largedifference in impairments between the in-tervention group and the control group(58% versus 14%). The third trial is a ran-domized, controlled trial of differentfootwear conducted in Ethiopia (") thatalso demonstrated benefit; this studydemonstrated that canvas shoes with cush-ioned insoles were both cost-effective andacceptable.

Recommendations.

• Teaching and empowering patients inself-care is an effective activity, whichshould be part of all leprosy programs.

• Use of locally acceptable, appropriatefootwear is a cost-effective interventionfor those with loss of plantar sensation.

2.5 Socio-economic rehabilitationMany of the earlier initiatives in rehabili-

tation focused on physical approaches. Thatthe importance of social and economic as-pects of rehabilitation is now being empha-sized is evidenced by the recently producedguidelines for socio-economic rehabilita-tion (49 50). Most publications describe ex-amples or case-studies in socio-economicrehabilitation. Two studies that describe anevaluation of such an approach were con-ducted in India. The first reported (5') bene-fits from restoration of social and economicstatus. The second was an evaluation of acommunity-based rehabilitation initiative(52). Both studies stress the importance ofparticipation of the client as well as in-volvement of the family and the commu-nity.

Self-care, footwear and rehabilitation ac-tivities are often combined within a pro-gram. Six published studies, all of whichemployed before-and-after designs, repre-sent evaluations of the effectiveness ofcombined programs, and one considers afootwear and loan program. The six studiesanalyzing self-care and footwear programswere conducted in China ("' 54), India (55),and Senegal (56-58). The footwear and loanproject was based in Chad (59). The two

S44 International Journal of Leprosy 2002

studies in China showed beneficial effects,the study in India showed a 50% reductionof plantar ulcers, and the studies in Senegalshowed improvement of between 33 and 62per cent. The study of loans also reported abeneficial outcome.

Recommendations.

• Socio-economic rehabilitation, which re-quires participation by client, family andthe community, is valuable for selectedpatients.

• Socio-economic rehabilitation for thoseaffected by leprosy are best deliveredthrough general community based reha-bilitation programmes.

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