| CTRI Number |
CTRI/2021/09/036139 [Registered on: 01/09/2021] Trial Registered Prospectively |
| Last Modified On: |
17/03/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Mixed methods |
| Study Design |
Other |
|
Public Title of Study
|
Development of a tool to measure User-satisfaction with Game-based Treatment in Stroke |
|
Scientific Title of Study
|
Development and Validation of Patient Reported Outcome Measure to assess User-satisfaction with Game-based Rehabilitation in Stroke |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
G Shivani |
| Designation |
Postgraduate student |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Physiotherapy,
Manipal College of Health Professionals, Manipal Academy of Higher Education,
Manipal
Udupi
KARNATAKA
576104.
India |
| Phone |
8106456772 |
| Fax |
|
| Email |
shivani.gollamudi@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSenthil Kumaran D |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Physiotherapy,
Manipal College of Health Professions,
Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
09986910303 |
| Fax |
|
| Email |
senthil.kumaran@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr John Solomon M |
| Designation |
Associate Professor Senior Scale, Coordinator- CCSRR |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Physiotherapy,
Manipal College of Health Professions,
Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9945670671 |
| Fax |
|
| Email |
john.solomon@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of physiotherapy
Manipal College of Health Professions
Manipal Academy of Higher Education
Manipal-576104 |
|
|
Primary Sponsor
|
| Name |
G Shivani |
| Address |
Department of Physiotherapy, Manipal College of Health Professionals,
Manipal Academy of Higher Education,
Manipal - 576104.
|
| Type of Sponsor |
Other [self] |
|
|
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 |
| G Shivani |
Kasturba Hospital,Manipal |
Neuro physiotherapy OPD,
Department of physiotherapy Madhav Nagar, Tiger
circle, Manipal-576104
Udupi KARNATAKA
Udupi
KARNATAKA
Udupi
KARNATAKA |
8106456772
shivani.gollamudi@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I633||Cerebral infarction due to thrombosis of cerebral arteries, (2) ICD-10 Condition: I639||Cerebral infarction, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
(a) Patients :-
1. Patients who are clinically diagnosed with stroke
2. Patients must have undergone game-based rehabilitation intervention for at least five sessions.
3. Patients should understand simple commands
(b) Experts included would be physiotherapists; occupational therapists (one-year experience in the field of game-based rehabilitation); game developers and clinical psychologist (experienced with stroke patients).
|
|
| ExclusionCriteria |
| Details |
Aphasic stroke patient |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Validation of the Patient Reported Outcome Measure |
1 time |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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 3 |
|
Date of First Enrollment (India)
|
10/09/2021 |
| 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="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study’s objective is to analyse the components of patient’s satisfaction along with the factors that would affect the satisfaction with game-based rehabilitation in stroke population. And to develop and then validate the Patient Reported Outcome Measure (PROM) that would assess the user satisfaction after a Game-based Rehabilitation in Stroke patients. The project if divided into 2 phases, phase 1 would be have a literature review would be conducted to gather all the items in the tools used to assess user-satisfaction in neurological rehabilitation, interview with the patient and questions from an interview guide related to their satisfaction of using game-based rehabilitation and the interview would be audio recorded. The audio would then be transcribed and analyzed, next a focus group discussion would be conducted among experts. A PROM will be drafted (PROM draft 1) based on the results obtained from the literature review, patient interview, focus group discussion. An appropriate scoring system would be decided for the PROM draft 1. The second phase would be the content validation of the PROM by physiotherapist and occupational therapists. The changes suggested by the professionals would be incorporated and a PROM draft 2 followed by pilot study, Patients would be instructed to fill it based on their satisfaction with the game-based rehabilitation. Any difficulties to understand any item would be noted the necessary changes would be made in the final version of the measure. |