| CTRI Number |
CTRI/2022/11/047250 [Registered on: 14/11/2022] Trial Registered Prospectively |
| Last Modified On: |
08/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Behavioural |
| Study Design |
Other |
|
Public Title of Study
|
Making and Verifying an Occupational Therapy Home Program at discharge from hospital after Acute Stroke |
|
Scientific Title of Study
|
Development and Validation of an Occupational Therapy Home Program at Discharge from Hospital Following Acute Stroke |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nevita Saha |
| Designation |
Postgraduate Student |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Occupational Therapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9013501838 |
| Fax |
|
| Email |
nevita.saha@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Sebestina Anita Dsouza |
| Designation |
Guide |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Occupational Therapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9448152143 |
| Fax |
|
| Email |
sebestina.dsouza@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Nevita Saha |
| Designation |
Postgraduate Student |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Occupational Therapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Madhav Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9013501838 |
| Fax |
|
| Email |
nevita.saha@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal Academy of Higher Education, Tiger Circle, Madhav Nagar, Manipal, Karnataka, 576104 |
|
|
Primary Sponsor
|
| Name |
Nevita Saha |
| Address |
Manipal College of Health Professions, Manipal Academy of Higher Education, Madhav Nagar, Karnataka, 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 |
| Nevita Saha |
Kasturba Hospital, Manipal |
Neurorehabilitation Room, Department of Occupational Therapy, Baliga Block-Ground Floor, Kasturba Hospital, Madhav Nagar, Karnataka, 576104
Udupi
KARNATAKA |
9013501838
nevita.saha@learner.manipal.edu |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee 2 (Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I639||Cerebral infarction, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Occupational Therapy professionals who have been providing therapy to stroke patients for atleast 1 year.
Stroke patients referred to occupational therapy department. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Qualitative data about perpectives of occupational therapists providing home programs to stroke patients. |
baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="19"
Sample Size from India="19"
Final Enrollment numbers achieved (Total)= "5"
Final Enrollment numbers achieved (India)="5" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/11/2022 |
| Date of Study Completion (India) |
21/04/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
21/04/2023 |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Aim: To develop and validate an Occupational Therapy Home Program for Stroke (OTHP-Stroke) at discharge from hospital following acute stroke.
Objectives: - To understand occupational therapists’ perspectives about the content of home programs to be provided to stroke survivors and caregivers at discharge from hospital following stroke.
- To develop the OTHP-Stroke.
- To validate the OTHP-Stroke.
Justification:
Home programs are a salient component of stroke rehabilitation especially in resource-constrained settings like India. Mobile-based home programs are currently being researched as a viable option and are relatively in nascent phase of development. However, several challenges have been reported such as technical difficulties and the need for caregiver training for using mobile applications. Till these are well established and accessible, conventional home programs continue to be pertinent in India. However currently structured home programs or guidelines are unavailable. This may impact the provision of home programs. For example, therapists may not be able to address all aspects of home programs due to insufficient time, difficulty in personalizing the home program to the stroke survivors and caregivers needs, etc. Similarly, caregivers may have difficulty to follow the home program at home especially if only verbal instructions were provided. This may impact the recovery of the stroke survivor. The current practice of home program provision could be facilitated through a template that provides structure but offers flexibility to tailor according to stroke survivors and caregivers needs. The present study intends to develop such a template. |