Exercising Wrist muscles assisted with robotic hand and brain stimulation therapy in hospital set up

Phase 2/3

Recruiting

Conditions: Hemiplegia, unspecified,

Registration Number: CTRI/2020/05/024992

Lead Sponsor: Ministry of Defense

Brief Summary: Stroke is one of the leading causes of mortality andmorbidity worldwide including India. Upper extremity complications are mostcommon and may be seriously debilitating, affecting the quality of life.Robotic devices offer a unique training environment that may enhance outcomesbeyond what is possible with conventional means but are limited to proximaljoints and are highly expensive. We have developed an exoskeleton for distaljoints rehabilitation (wrist and fingers) in consultation with expxerts from Department of Neurology, AIIMS. This study aims totest the robotic exoskeleton on stroke patients synchronized with brainstimulation. The study aims to linkthe exoskeleton with a mobile app to monitor the operation of exoskeleton andassess the clinical improvement of patients over the therapy sessions. All devicerelated further developmental work and analysis of data will be performed byBiomedical Engineering, IIT Delhi. Patient recruitment and therapy will be doneat site Department of Neurology AIIMS, New Delhi.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 120

Inclusion Criteria

Single lesion Chronic stroke(3-120months) cortical/subcortical Ischemic/Hemmorhagic Stroke Modified Ashworth Scale (1 1+ 2 3) Brunnstorm Stage (3-5) 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	Clinical Scales of Rehabilitation and \| NeuroPhyiological Signals will be taken at 2 time points, 1 at time of enrollment and 2 at end of intervention at 4weeks
fMRI changes	Clinical Scales of Rehabilitation and \| NeuroPhyiological Signals will be taken at 2 time points, 1 at time of enrollment and 2 at end of intervention at 4weeks
Ashworth Scale, Brunnstorn Stage,	Clinical Scales of Rehabilitation and \| NeuroPhyiological Signals will be taken at 2 time points, 1 at time of enrollment and 2 at end of intervention at 4weeks
Motor Evoked Potential Changes,	Clinical Scales of Rehabilitation and \| NeuroPhyiological Signals will be taken at 2 time points, 1 at time of enrollment and 2 at end of intervention at 4weeks
Electromyography changes,	Clinical Scales of Rehabilitation and \| NeuroPhyiological Signals will be taken at 2 time points, 1 at time of enrollment and 2 at end of intervention at 4weeks
Cortical Excitability,	Clinical Scales of Rehabilitation and \| NeuroPhyiological Signals will be taken at 2 time points, 1 at time of enrollment and 2 at end of intervention at 4weeks

Secondary Outcome Measures

Name	Time	Method
Barthel Index (BI), Modified Rankin Scale, Motor Assessment Scale(MoAS), FMA, Edinburg Laterality index, Stroke rehabilitation Motivation Scale	Clinical Scales of Rehabilitation will be taken at 2

Trial Locations

Locations (1): All Indian Institute of Medical Sciences
🇮🇳
South, DELHI, India
All Indian Institute of Medical Sciences
🇮🇳South, DELHI, India
Dr M V Padma Srivastava
Principal investigator
011-26594794
vasanthapadma123@gmail.com