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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.




 
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