| CTRI Number |
CTRI/2020/05/024992 [Registered on: 04/05/2020] 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 Synchronized Brain Stimulation] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Exercising Wrist muscles assisted with robotic hand and brain stimulation therapy in hospital set up |
|
Scientific Title of Study
|
Brain Computer Interface for Facilitated Neuroplasticity: Upper Limb Rehabilitation with EMG Triggered Exoskeletal Robotic Device Synchronized with Brain Stimulation |
| 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 Delhi |
| Address |
Centre for Biomedical Engineering Indian Institute of Technology
Delhi Hauz Khas
South
DELHI
110016
India |
| Phone |
|
| Fax |
|
| Email |
amitvmehndiratta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amit Mehndiratta |
| Designation |
Assistant Professor |
| Affiliation |
Indian Institute of Technology Delhi |
| Address |
Centre for Biomedical Engineering Indian Institute of Technology
Delhi Hauz Khas
DELHI
110016
India |
| Phone |
|
| Fax |
|
| Email |
amitvmehndiratta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amit Mehndiratta |
| Designation |
Assistant Professor |
| Affiliation |
Indian Institute of Technology Delhi |
| Address |
Centre for Biomedical Engineering Indian Institute of Technology
Delhi Hauz Khas
DELHI
110016
India |
| Phone |
|
| Fax |
|
| Email |
amitvmehndiratta@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ministry of Defense, Government of India, Indian Institute of Technology Delhi |
|
|
Primary Sponsor
|
| Name |
Ministry of Defense |
| Address |
Joint Advanced Technology Center (JATC), DRDO, Block-V,Room 418, IIT Delhi, Hauz Khas, New Delhi 110016 |
| Type of Sponsor |
Government funding agency |
|
|
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
South
DELHI |
011-26594794
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
|
Patient will be asked to do
robotic assistive rehabilitation
therapy, for 45 minutes
a day, for 5 days a week for 20 sessions |
| Intervention |
TMS integrated with Robotic exoskeleton device |
Patient will be asked to undergo
TMS and robotic assisted therapy
therapy at hospital, for 45 minutes
a day, for 5 days a week for 20 sessions |
| Intervention |
TMS therapy at hospital |
Patient will be asked to undergo
TMS
therapy at hospital, for 45 minutes
a day, for 5 days a week for 20 sessions
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
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)
|
|
| 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,
Electromyography changes,
Cortical Excitability,
Motor Evoked Potential Changes,
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 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 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
time points, 1 at time of enrollment and 2 at end of intervention (4weeks) |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
04/05/2020 |
| 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="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
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 offer a unique training environment that may enhance outcomes
beyond what is possible with conventional means but are limited to proximal
joints and are highly expensive. We have developed an exoskeleton for distal
joints rehabilitation (wrist and fingers) in consultation with expxerts from Department of Neurology, AIIMS. This study aims to
test the robotic exoskeleton on stroke patients synchronized with brain
stimulation. The study aims to link
the exoskeleton with a mobile app to monitor the operation of exoskeleton and
assess the clinical improvement of patients over the therapy sessions. 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. |