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

Phase 1/2

Completed

Conditions: Hemiplegia, unspecified,

Registration Number: CTRI/2021/06/034305

Lead Sponsor: Manipal Academy of Higher Education

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 40

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Simplified-Stroke Rehabilitation Assessment of Movement	Baseline at time of discharge. \| Follow up after 4 weeks
Modified Barthel Index	Baseline at time of discharge. \| Follow up after 4 weeks
Stroke Specific Quality of Life Scale	Baseline at time of discharge. \| Follow up after 4 weeks

Secondary Outcome Measures

Name	Time	Method
Stroke-Specific Measure of Adherence to Home-based Exercises

Trial Locations

Locations (1): KMC Mangalore
🇮🇳
Kannada, KARNATAKA, India
KMC Mangalore
🇮🇳Kannada, KARNATAKA, India
Sushmita Shenoy
Principal investigator
9096211832
sushmita.shenoy1@learner.manipal.edu