| CTRI Number |
CTRI/2017/06/008860 [Registered on: 19/06/2017] Trial Registered Retrospectively |
| Last Modified On: |
16/06/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Process of Care Changes |
| Study Design |
Other |
|
Public Title of Study
|
Interactive training devices for people with hand weakness |
|
Scientific Title of Study
|
A system for home-based rehabilitation of the stroke paralyzed hand |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Akhil Mohan |
| Designation |
PG Trainee (Ph.D) |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Department of Bioengineering, Rehabilitation Campus, Bagayam
Vellore
TAMIL NADU
632002
India |
| Phone |
07639168728 |
| Fax |
|
| Email |
akhilmohan@cmcvellore.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Suresh R Devasahayam |
| Designation |
Professor |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Department of Bioengineering, Rehabilitation Campus, Bagayam
Department of Bioengineering, Rehabilitation Campus, Bagayam
Vellore
TAMIL NADU
632002
India |
| Phone |
04162285098 |
| Fax |
|
| Email |
surdev@cmcvellore.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Akhil Mohan |
| Designation |
PG Trainee (Ph.D) |
| Affiliation |
Christian Medical College, Vellore |
| Address |
Department of Bioengineering, Rehabilitation Campus, Bagayam
Vellore
TAMIL NADU
632002
India |
| Phone |
07639168728 |
| Fax |
|
| Email |
akhilmohan@cmcvellore.ac.in |
|
|
Source of Monetary or Material Support
|
| Project Name - Post Graduate Training Programme
Account No - 22D248
Department of Bioengineering Christian Medical College Vellore
Rehabilitation Campus, Bagayam
632002
TamilNadu |
|
|
Primary Sponsor
|
| Name |
Department of Bioengineering Christian Medical College Vellore |
| Address |
Rehabilitation Campus, Christian Medical College, Vellore |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Department of Physical Medicine and Rehabilitation Christian Medical College Vellore |
Rehabilitation Campus, Christian Medical College, Vellore |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Akhil Mohan |
Christian Medical College |
Department of Physical Medicine and Rehabilitation, Rehabilitation Campus, Christian Medical College, Vellore
Vellore
TAMIL NADU |
07639168728
akhilmohan@cmcvellore.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board Christian Medical College Vellore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Stroke, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Interactive games based rehabilitation and standard therapy |
Part 1 :-
The user is encouraged to use the new hand rehabilitation system as much as possible on their own apart from the intervention period. A video camera records the activity performed by the user at the start of the intervention (T0 - 10 minutes of recording on the first session on day 1 and day 3 and includes both the therapist assisted hand exercises and passive new games based hand exercises), mid of the intervention (T1 - 10 minutes of recording on the first session on day 14 and includes both the therapist assisted hand exercises and new games based hand exercises), and at the end of intervention (T2 - 10 minutes of recording on the first session on day 28 and includes both the therapist assisted hand exercises and new games based hand exercises). The primary outcome measures would be the count of movements performed, movement range and quality of movement. These outcome measures from therapist assisted rehabilitation session using video camera will be compared with the new sensor based rehabilitation session.
We would also like to measure the usability of the new rehabilitation devices among the stroke subjects and for the same they will be asked to fill a questionnaire at the end of the study which will be used as a secondary outcome measure[ system usability scale (SUS)].
Part 2:-
Depending upon the count of movements performed, movement range and quality of movement using the new sensorized hand rehabilitation system, a scoring scheme will be designed. This computer based score obtained from the game will be correlated with an existing assessment tool FMA (Fugl-Meyer Assessment of motor recovery after stroke) for comparison. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Stroke patients with Brunstrom stage 3 and above hemiparesis |
|
| ExclusionCriteria |
| Details |
Movement restricted due to musculo-skeletal problems, patients with global aphasia, patients with cognitive deficit and other neurological disorders. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. The primary outcome would be the count of movements performed, movement range and quality of movement. The therapist assisted rehabilitation session will be compared with the new sensor based rehabilitation.
2. FMA (Fugl-Meyer Assessment of motor recovery after stroke)
3. System Usability Scale (SUS) |
Study 1 :-
Four phases of assessment,
Day 1, Day 3, Day 14 and Day 28
SUS will be given only on the last day (28th).
Study 2 :-
One time assessment - Day 1 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1. Clinical assistance provided |
Qualitative measure recorded on a daily basis in study 1 (from day 1 to day 28).
One time measurement - day 1 in study 2 |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 1 |
|
Date of First Enrollment (India)
|
15/05/2017 |
| 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)
|
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 the principal cause of adult disabilities in India and third leading cause of death worldwide [1]. The major outcome of stroke is weakness of one side of the body due to damage of the affected brain region. As a result the control of skills that are necessary for the activities of daily living (ADL) are compromised. Controlled, focused, patient specific rehabilitation treatments have shown positive results on functional recovery after stroke [2]. Rehabilitation treatment in a hospital primarily involves one-to-one interaction of patient with a therapist where the patient is taught to perform different exercises and functional activities that are necessary for ADL. During the first stage of rehabilitation of upper extremity, shoulder and elbow functions are usually restored at least partially. The recovery of the wrist and fingers is the last chronologically. Therapy for the wrist and hand is labour intensive and prolonged and often takes several months. Therefore, once part of the function is regained the patient would prefer to go home and continue therapy with the help of a therapist. But this is not done systematically and leaves the patient with chronic impairments.
The development of portable finger and wrist rehabilitation devices (sensorized glove and instrumented objects) offer an opportunity to continue therapy/exercises at home or community environments taking minimal input from a therapist. Also the devices can work in a more intense, repetitive, time unconstrained manner providing more exercises in the form of interactive, adaptive computer games and thus may facilitate motor recovery in a faster manner.
1. TK Banerjee and SK Das, “Epidemiology of stroke in India,†Neurology Asia, 2006, pp. 1-4. 2. N. Friedman, V. Chan, A.N. Reinkensmeyer, A. Beroukhim, G.J. Zambrano, M. Bachman, D.J. Reinkensmeyer, "Retraining and assessing hand movement after stroke using the MusicGlove: comparison with conventional hand therapy and isometric grip training", J. NeuroEngineering and Rehabilitation, 2014, 11:76. |