| CTRI Number |
CTRI/2022/09/045912 [Registered on: 27/09/2022] Trial Registered Prospectively |
| Last Modified On: |
30/08/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Neurorehabilitation for the recovery of hand function in subjects after the stroke. |
|
Scientific Title of Study
|
Neurorehabilitation Of The Hand Post Stroke Using The Myhandtm System In A Sub-Acute Population |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anirudh Chirania |
| Designation |
Consultant physiatrist |
| Affiliation |
Apollo Hospitals |
| Address |
ApoKOS Rehabilitation Hospital
Ground floor (Beside Consultation room no.1)
Apollo health city
Jubilee hills
Hyderabad
Hyderabad
TELANGANA
500096
India |
| Phone |
9674011468 |
| Fax |
|
| Email |
anirudh.chirania@apokos.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anirudh Chiranaia |
| Designation |
Principal Investigator |
| Affiliation |
ApoKOS Rehabilitation Center |
| Address |
ApoKOS Rehabilitation Hospital Ground floor (Beside Consultation room no.1), Apollo health city, Jubilee hills
Hyderabad
TELANGANA
500096
India |
| Phone |
9133336577 |
| Fax |
|
| Email |
anirudh.chirania@apokos.in |
|
Details of Contact Person
Public Query
|
| Name |
G Praveen Kumar |
| Designation |
Clinical trials- Senior Manager |
| Affiliation |
Apollo Research & Innovations, Apollo Hospitals |
| Address |
Apollo Research and Innovations, Department of Clinical trials, 1st Floor, Auditorium Building, Apollo Medical College,
Apollo Hospitals, Jubilee Hills
Hyderabad
TELANGANA
500096
India |
| Phone |
04029882130 |
| Fax |
|
| Email |
praveenkumar@apolloari.com |
|
|
Source of Monetary or Material Support
|
| IRegained Inc.,
1545 Maley Drive
Sudbury, Ontario
Canada, P3A 4R7
|
|
|
Primary Sponsor
|
| Name |
IRegained Inc |
| Address |
IRegained Inc.
c/o Norcat Innovation
1545 Maley Drive
Sudbury
Ontario
Canada
P3A 4R7 |
| Type of Sponsor |
Other [Medical device manufacturer] |
|
|
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 Anirudh Chirania |
Apollo Hospitals |
ApoKOS Rehabilitation Hospital
Ground floor (Beside Consultation room no.1)
Apollo health city
Jubilee hills
Hyderabad
500096
Hyderabad
TELANGANA |
9674011468
anirudh.chirania@apokos.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F||Physical Rehabilitation and Diagnostic Audiology, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hand training using a device |
IRegained MyHandTMSystem to be used in training of hand movements for duration of 3 days per week for 6 weeks. |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Unilateral upper limb impairment caused by a single stroke at least 2 weeks to 6 months prior to the start of the study.
2. Healthy (or corrected-to-normal) vision and hearing abilities to understand the information communicated by the research investigators.
3. Ambulatory, and/or able to travel to research study location.
4. CMSA: Level 3 or greater for hand function, and Shoulder pain
5. MMSE score ≥ 24
6. Capacity to consent is established
|
|
| ExclusionCriteria |
| Details |
1. Diagnosis of a neurological disorder other than stroke that can impede in hand function therapy (e.g. peripheral neuropathy, myopathies, Parkinson’s disease etc.)
2. Participants suffering from osteoarthritis or other musculoskeletal or neuromuscular disorders that affect hand function.
3. Participants with severe systemic disease that has an impact on hand function
4. Participants with severe spasticity or contractures, that has a limiting impact on hand function therapy. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Efficacy of the IRegained MyHandTM System and assessment of objective & subjective changes as a result of the hand function training |
16 to 18 sessions of training |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe objective and subjective changes in hand function as a result of hand-function training |
16 to 18 sessions of training |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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
|
N/A |
|
Date of First Enrollment (India)
|
05/10/2022 |
| 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="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not yet decided |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
IRegained aims to train stroke survivor participant’s hands using the IRegained MyHandTM System with the objective of improving hand and finger function. The system provides passive resistance and allows participants to perform targeted grasp functions at varying resistances as per their ability. The training will involve exercises to train individual finger function, and grasping tasks such as the pinch, tripod, quadripod and spherical grasp. To improve motor function, the training will target both the intrinsic and extrinsic musculature of the hand. Consented participants will undergo hand function training 3 days per week over a 6-week period, with each participating patient receiving 18 sessions of hand function training (minumum of 16 sessions).
The project will investigate a) the efficacy of the IRegained MyHandTM System in training hand function in individuals post stroke and b) observe objective and subjective changes in hand function as a result of hand-function training. |