Exercising muscles of hand with help of a robotic device at home

Phase 2/3

Recruiting

Conditions: Hemiplegia, unspecified,

Registration Number: CTRI/2019/03/018100

Lead Sponsor: IIT Delhi IRD Unit

Brief Summary: Stroke is one of the leading causes of mortality and morbidity worldwide including India. Upper extremity complications are most common and may be seriously debilitating, affecting the quality of life. Robotic devices based assistive rehabilitation might offer a unique training environment that may enhance clinical rehabilitation outcomes beyond what is possible with conventional therapy such as physiotherapy. We have developed an exoskeleton for distal joints rehabilitation (wrist and fingers) in consultation with experts from Department of Neurology, AIIMS. This proposed pilot clinical study aims to evaluate the robotic exoskeleton assistive rehabilitation therapy on stroke patients at home against the comparator clinical physiotherapy which is the current standard of clinical care. The developmental work for device has been done at Biomedical Engineering, IIT Delhi which is a joint department of IIT Delhi and AIIMS. All device related further developmental work and analysis of data will be performed by Biomedical Engineering, IIT Delhi. Patient recruitment and therapy will be done at site Department of Neurology AIIMS, New Delhi.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 20

Inclusion Criteria

Single lesion Chronic stroke(3-24months) cortical/subcortical Ischemic/Hemmorhagic Stroke Modified Ashworth Scale (1 1+ 2) Brunnstorm Stage (2-5) Wrist extension EMG activity present Able to give informed consent and follow instructions to execute training task Mini Mental State Examination(24-30).

Exclusion Criteria

Contraindications to TMS,progressive neurological or cognitive disorders impringing with assessment scales.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical Scales of Rehabilitation: Modified Ashworth Scale, Brunnstorn Stage;	Clinical Scales of Rehabilitation & NeuroPhyiological Signals: will be taken at 2 time points, 1 at time of enrollment and 2 at end of intervention (4weeks).
Clinical NeuroPhyiological Signals: Electromyography changes; fMRI changes; Motor Evoked Potential Changes	Clinical Scales of Rehabilitation & NeuroPhyiological Signals: will be taken at 2 time points, 1 at time of enrollment and 2 at end of intervention (4weeks).

Secondary Outcome Measures

Name	Time	Method
Modified Barthel Scale; Barthel Index, Wolf Motor Function Test; Fugl Meyer Scale	Clinical Scales of Rehabilitation will be taken at 2 time points, 1 at time of enrollment and 2 at end of intervention (4weeks).

Trial Locations

Locations (1): All Indian Institute of Medical Sciences
🇮🇳
Delhi, DELHI, India
All Indian Institute of Medical Sciences
🇮🇳Delhi, DELHI, India
Dr M V Padma Srivastava
Principal investigator
vasanthapadma123@gmail.com