| Registry | NCT07734818 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, other |
| Enrollment | 20 (Estimated) |
| Sponsor | Lahore University of Biological and Applied Sciences (Other) |
| Conditions | Stroke |
| Interventions | mhealth, Routine Physical Therapy (Device, other) |
| Dates | start 2026-08-15 (estimated), primary completion 2027-02-10 (estimated), completion 2027-02-10 (estimated), first posted 2026-07-29, last updated 2026-07-29 |
| Locations | 2 sites in Pakistan |
Related Papers Related Patents Related Grants Related Experts
All trials for Stroke All trials of mhealth All trials of Routine Physical Therapy
impairments that limit functional independence. This study aims to develop and validate a bilingual (English and Urdu) mobile application to improve upper limb function in stroke survivors through structured, task-oriented exercises. It will be conducted in two phases: app development and validation, followed by a pilot randomized controlled trial. A total of 20 participants will be recruited using convenience sampling and randomly assigned to either a clinical exercise-based group or an app-based training group, with allocation concealment ensured through sealed envelopes. The study will follow a double-blinded design, where both participants and the outcome assessor will be blinded. Outcomes will be measured using the Wolf Motor Function Test (WMFT), Fugl- Meyer Assessment (FMA), and Nine Hole Peg Test (NHPT). The study aims to provide an accessible, evidence-based digital solution to enhance functional recovery and improve quality of life in stroke survivors.
Stroke is a leading cause of long-term disability, often resulting in significant upper limb impairments that affect motor ability, coordination, and independence in daily activities. This study aims to develop and validate a bilingual (English and Urdu) mobile application designed to improve upper limb function in stroke survivors through structured, task-oriented rehabilitation exercises. The application will provide an accessible platform for home-based therapy, promoting patient engagement, continuous monitoring, and functional recovery. The study will be conducted in two phases: the first phase will focus on the development and validation of the mobile application, while the second phase will involve a pilot randomized controlled trial to evaluate its usability and effectiveness. A total of 20 stroke patients will be recruited using a convenience sampling technique. After initial screening, participants will be randomly allocated into two groups: a clinical exercise-based group and an app-based upper extremity training group using an online randomization tool. Allocation concealment will be ensured through the sealed envelope method to minimize selection bias. The study will follow a double-blinded design, where both participants and the outcome assessor will be blinded; the assessor will remain unaware of group allocation, and participants will be blinded to the study hypothesis. The effectiveness of the intervention will be evaluated using standardized outcome measures, including the Wolf Motor Function Test (WMFT) to assess motor ability, the Fugl-Meyer Assessment (FMA) to evaluate motor impairment, and the Nine Hole Peg Test (NHPT) to measure fine motor dexterity. By integrating evidence-based rehabilitation with a bilingual digital platform, this study aims to provide a comprehensive and accessible intervention that can enhance functional outcomes, promote independence in daily activities, and improve the overall quality of life for stroke survivors.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Clinical Exercise group | Active comparator | Other: Routine Physical Therapy | Participants in the Clinical Exercise-Based Group will receive standard physiotherapy in a clinical setting, including range-of-motion, strengthening, task-specific functional, and repetitive motor exercises for the affected upper limb. Sessions will be conducted 3 times per week for 45 minutes over 8 weeks following standardized clinical protocols. |
| m Health | Experimental | Device: mhealth | Participants receive upper limb rehabilitation via a mobile app with structured exercises for range of motion, strengthening, and functional tasks targeting the shoulder, elbow, wrist, and hand to improve motor control and coordination. Sessions last 45 minutes, 3 times weekly for 8 weeks. |
Sex: All, ages: 40 Years to 60 Years
Inclusion Criteria: Subacute and chronic stroke patient > 3 months post stroke. Modified Ashworth scale <3 MOCA > 24. An ability to understand the command First ever stroke Grade II, III, IV on Functional mobility Scale Able to use and comprehend smart phone. Exclusion Criteria: Posterior circulation stroke. Vestibular disorders, paroxysmal vertigo Presence of other neurological conditions such as neglect, hemianopsia and pushing syndrome Presence of orthopedic diseases involving the upper limb
| Facility | City | Country | Status |
|---|---|---|---|
| Services Hospital | Lahore, Punjab Province | Pakistan | |
| Lahore University of Biological and Applied Sciences | Lahore, Punjab Province | Pakistan |