DOI: http://dx.doi.org/10.18203/2349-3259.ijct20180132

Comparison of the outcomes of home based and supervised individually designed exercise programme amongst the patients in chronic phase after guillain barre syndrome: study protocol for a randomized control trial

Nehal Shah, Manisha Shrivastava, Sanjeev Kumar, Nirendra Rai

Abstract


Background: Guillain barre syndrome (GBS) is an immune mediated polyneuropathy characterized by progressive weakness and variety of symptoms including muscle paralysis, autonomic dysfunction and respiratory involvement that affect one or two persons in 100,000 population. Although immunotherapies including therapeutic plasma exchange (TPE), immunoglobulins (IVIg) and corticosteroids are the available beneficial modes of treatment, the residual symptoms are disabling and long lasting and require long term rehabilitation. Observational studies and RCT on multi-disciplinary care has proven exercises to be an answer to residual long lasting disability. Supervised individually designed exercise prescription after physiotherapy assessment may play a major role in minimizing disability.

Methods: The present study is an open-level, parallel, superiority randomized control trial with blinding of outcome assessors to evaluate the results of the individually designed exercise programme over home based exercise programme. 74 adult referred GBS patients will be recruited and randomize in two groups either to receive 12 weeks individually designed exercise programme or home based exercise programme. The primary outcome shall be assessed as functional independence in activities of daily living and secondary outcomes shall be evaluated in terms of muscle strength, fatigue, pain, and quality of life at baseline, six months and twelve months duration.

Conclusions: This is the first randomized control trial to compare the effect of supervised individually designed exercise over home based exercise programme on pwGBS.

Trial registration: Currently the trial is ethically approved, prospectively registered CTRI/2016/08/007150 and in the process of recruiting its first subjects.


Keywords


Guillain barre syndrome, Superiority randomized control trial, Physiotherapy

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