CTRI Number |
CTRI/2021/06/034305 [Registered on: 18/06/2021] Trial Registered Prospectively |
Last Modified On: |
09/05/2022 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Physiotherapy (Not Including YOGA) |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
A study to test whether mobile-based applications (apps) used along with home exercises taught to stroke patients after their discharge from hospital is effective or not |
Scientific Title of Study
|
EFFECTIVENESS OF HOME EXERCISE PROGRAM WITH MOBILE-HEALTH APPLICATIONS (APPS) IN THE FUNCTIONAL RECOVERY OF POST-DISCHARGE STROKE SURVIVORS- A RANDOMIZED CONTROLLED TRIAL |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Sushmita Jayaram Shenoy |
Designation |
Postgraduate student |
Affiliation |
KMC Mangalore, Manipal Academy of Higher Education |
Address |
Department of Physiotherapy Centre for Basic Sciences Kasturba Medical College Bejai Mangalore
Dakshina Kannada KARNATAKA 575004 India |
Phone |
9096211832 |
Fax |
|
Email |
sushmita.shenoy1@learner.manipal.edu |
|
Details of Contact Person Scientific Query
|
Name |
Dr Vijay Kumar |
Designation |
Associate Professor |
Affiliation |
KMC Mangalore,Manipal Academy of Higher Education |
Address |
Department of Physiotherapy Centre for Basic Sciences Kasturba Medical College Bejai Mangalore
Dakshina Kannada KARNATAKA 575004 India |
Phone |
9980189597 |
Fax |
|
Email |
vijay.kk@manipal.edu |
|
Details of Contact Person Public Query
|
Name |
Dr Vijay Kumar |
Designation |
Associate Professor |
Affiliation |
KMC Mangalore, Manipal Academy of Higher Education |
Address |
Department of Physiotherapy Centre for Basic Sciences Kasturba Medical College Bejai Mangalore
Dakshina Kannada KARNATAKA 575004 India |
Phone |
9980189597 |
Fax |
|
Email |
vijay.kk@manipal.edu |
|
Source of Monetary or Material Support
|
Manipal Academy of Higher Education |
|
Primary Sponsor
|
Name |
Manipal Academy of Higher Education |
Address |
Light house, Hill road, Mangalore 575001 |
Type of Sponsor |
Private medical college |
|
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 |
Sushmita Shenoy |
KMC Mangalore |
Department of physiotherapy, 2nd floor, KMC hospital, Attavar, Mangalore
Department of physiotherapy, 5th floor, KMC hospital, Jyothi, Mangalore Dakshina Kannada KARNATAKA |
9096211832
sushmita.shenoy1@learner.manipal.edu |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee, Kasturba Medical College, Mangalore |
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 |
Intervention |
MHealth care group |
In addition to the prescribed usual home exercise program, participants will also be asked to use a mobile app according to their level of disability |
Comparator Agent |
Usual care group |
Participants will receive a prescribed home exercise program based on their level of disability |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
80.00 Year(s) |
Gender |
Both |
Details |
Adults (> 18 years of age) diagnosed with primary ischemic/hemorrhagic stroke with
hemiplegia/hemiparesis
Acute stroke survivors who have completed early in-patient rehabilitation and planning
for discharge
Participants should have at least one android smartphone with good internet connectivity
Should be able to follow and understand the English language.
|
|
ExclusionCriteria |
Details |
Severe cognitive problems (a score of >1 in the cognition component of the NIH Stroke
Scale)
Severe communication problems (a score of >1 in the language component of the NIH
Stroke Scale)
Severe comorbidities and other musculoskeletal or cardiopulmonary conditions which
limits the delivery of home exercise program
Participant functionally dependent due to other pre-existing illnesses
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Simplified-Stroke Rehabilitation Assessment of Movement
Modified Barthel Index
Stroke Specific Quality of Life Scale
|
Baseline at time of discharge.
Follow up after 4 weeks |
|
Secondary Outcome
|
Outcome |
TimePoints |
Stroke-Specific Measure of Adherence to Home-based Exercises
|
4 weeks after recruitment |
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
Phase of Trial
|
Phase 1/ Phase 2 |
Date of First Enrollment (India)
|
24/05/2022 |
Date of Study Completion (India) |
Date Missing |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Post-stroke participants undergoing inpatient physiotherapy rehabilitation will be approached. The purpose of the study will be explained to interested participants and the informed consent will be taken from willing participants Considering the inclusion and exclusion criteria, eligible participants will be selected. Participants will be screened. Eligible participants will be allotted into two groups by block randomization.
Usual care group: The Home Exercise Program will be prescribed based on their level of disability using the Modified Rankin Scale (MRS scores). The primary investigator will demonstrate with appropriate instructions and will train the stroke survivors/caregivers to follow the home exercise program. The participants will be asked to follow one session of these exercises at home for at least 5 days a week, for a minimum duration of 45 minutes per day. The home exercise program will be progressed by increasing the number of sets and repetitions every week.
MHealth care group: In addition to the prescribed home exercise program, the participants will be instructed and trained by the primary investigator in the use of mobile apps for at least three to four sessions. Two or more attempts to retrieve any function from the mobile app without any errors will be considered as successful instruction. The participants can directly contact the primary investigator for any queries regarding mobile apps.
Baseline measurement of all outcome measures will be taken by a blinded therapist at the time of discharge following inpatient rehabilitation. Once every week, the primary investigator will have a telephonic communication with all the participants to maintain the complaints of the prescribed home exercise program. Both groups will be instructed to maintain a logbook to assess adherence to the program. After 4 weeks, an appointment with the primary investigator will be scheduled for a follow-up review and the study related outcome measures for all the participants will be taken by the same blinded therapist.
|