EFFECTIVENESS OF HOME EXERCISE PROGRAM WITH MOBILE-HEALTH APPLICATIONS (APPS) IN THE FUNCTIONAL RECOVERY OF POST-DISCHARGE STROKE SURVIVORS- A RANDOMIZED CONTROLLED TRIAL
Trial Snapshot
- Phase
- Phase 1/2
- Status
- Completed
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Simplified-Stroke Rehabilitation Assessment of Movement
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 80.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Simplified-Stroke Rehabilitation Assessment of Movement
Time Frame: Baseline at time of discharge. | Follow up after 4 weeks
Modified Barthel Index
Time Frame: Baseline at time of discharge. | Follow up after 4 weeks
Stroke Specific Quality of Life Scale
Time Frame: Baseline at time of discharge. | Follow up after 4 weeks
Secondary Outcomes
- Stroke-Specific Measure of Adherence to Home-based Exercises