| CTRI Number |
CTRI/2019/03/018100 [Registered on: 15/03/2019] Trial Registered Prospectively |
| Last Modified On: |
21/02/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA)
Other (Specify) [Robotic Exoskeleton Assistive Device ] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Exercising muscles of hand with help of a robotic device at home |
|
Scientific Title of Study
|
Robotic Exoskeleton Therapy for Home-based Rehabilitation:A Pilot Randomized Clinical Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amit Mehndiratta |
| Designation |
Assistant Professor |
| Affiliation |
Indian Institute of Technology |
| Address |
Centre for Biomedical Engineering
Indian Institute of Technology Delhi
Hauz Khas
New Delhi
DELHI
110016
India |
| Phone |
011-26596230 |
| Fax |
|
| Email |
amitvmehndiratta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Mehndiratta |
| Designation |
Assistant Professor |
| Affiliation |
Indian Institute of Technology |
| Address |
Centre for Biomedical Engineering
Indian Institute of Technology Delhi
Hauz Khas
New Delhi
DELHI
110016
India |
| Phone |
011-26596230 |
| Fax |
|
| Email |
amitvmehndiratta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amit Mehndiratta |
| Designation |
Assistant Professor |
| Affiliation |
Indian Institute of Technology |
| Address |
Centre for Biomedical Engineering
Indian Institute of Technology Delhi
Hauz Khas
New Delhi
DELHI
110016
India |
| Phone |
011-26596230 |
| Fax |
|
| Email |
amitvmehndiratta@gmail.com |
|
|
Source of Monetary or Material Support
|
| IIT Delhi and AIIMS New Delhi - Multi Institutional Faculty Interdisciplinary Research Project (MIFIRP) |
|
|
Primary Sponsor
|
| Name |
IIT Delhi IRD Unit |
| Address |
IRD Unit, IIT Delhi, Hauz Khas, New Delhi 110016 |
| Type of Sponsor |
Other [Education and Research Autonomous Institution ] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr M V Padma Srivastava |
All Indian Institute of Medical Sciences |
Department of Neurology
New Delhi
DELHI |
26594794
vasanthapadma123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, All Indian Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G819||Hemiplegia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Physiotherapy for rehabilitation |
Patient will be asked to do clinical physiotherapy as prescribed by the therapist either at home or hospital |
| Intervention |
Robotic Exoskeleton Assistive therapy for home based rehabilitation |
Patient will be asked to do robotic assistive rehabilitation therapy at home, for 45 minutes a day, for 5 days a week for 4 consecutive weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
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) |
|
| ExclusionCriteria |
| Details |
Contraindications to TMS,progressive neurological or cognitive disorders impringing with assessment scales |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Clinical Scales of Rehabilitation: Modified Ashworth Scale, Brunnstorn Stage;
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
|
| Outcome |
TimePoints |
| 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). |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/04/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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. |