StrokeNCT07734818
Development and Validation of Mobile Application for Upper Limb Function in Stroke Survivors
A study testing mhealth and Routine Physical Therapy in people with Stroke, run by Lahore University of Biological and Applied Sciences at 2 sites in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Stroke
- What is being tested?
- mhealth and Routine Physical Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesPakistan
- Study dates
- 15 Aug 2026to 10 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan2 sites
Services Hospital
Lahore, Punjab Province, 54000
Aruba Saeed, Phd, 0334 4399403, arubaseed@gmail.com
Lahore University of Biological and Applied Sciences
Lahore, Punjab Province
Aruba Saeed, PhD, 0334 4399403, arubasaeedpt@gmail.com
About this study
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.
Read the detailed description
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.
- Conditions
- Stroke
- Being tested
- mhealth, Routine Physical Therapy
- Keywords
- Mobile application, Stroke survivors, Stroke rehabilitation for upper limb, stroke rehabilitation, personalized interventions, technology integration
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mhealthDevice
Progressive Training Plan (8 Weeks)
Phase I (Weeks 1-4): ROM \& Early Activation:
- Passive, active-assisted, and active range of motion exercises for shoulder, elbow, wrist, and hand
- Light strengthening with TheraBand and scapular stabilization
- Basic task practice (reaching, grasping, releasing objects) Dose:2-3 sets of 8-10 reps (tasks: 10-15 reps), rest 60-90 sec Focus: Improve mobility, reduce stiffness, and activate muscles
Phase II (Weeks 5-8): Strengthening \& Functional Training:
- Progressive resistance training for upper limb muscles
- Hand grip and pinch strengthening
- Advanced functional tasks (pegboard, object transfer, ADL simulation, bilateral activities) Dose:3-4 sets of 12-15 reps (tasks: 20-30 reps), rest 60-90 sec Focus: Increase strength, coordination, endurance, and functional recovery
Routine Physical TherapyOther
Range-of-Motion Exercises:
Include passive, active-assisted, and active movements of the shoulder, elbow, wrist, and fingers along with stretching to maintain joint mobility and reduce stiffness.
Strengthening Exercises:
Involve resisted upper limb exercises using TheraBands, weights, and therapy tools to improve shoulder, elbow, forearm, wrist, and hand strength, including grip and pinch strengthening.
Task-Specific Functional Activities:
Focus on functional and daily-life tasks such as reaching, grasping, object manipulation, pegboard tasks, ADL simulations, fine motor activities, and repetitive bilateral upper-limb training to enhance coordination and motor recovery.
| Study group | Role | What they receive |
|---|---|---|
| Clinical Exercise group | Active comparator | 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. Receives: Other: Routine Physical Therapy |
| m Health | Experimental | 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. Receives: Device: mhealth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wolf Motor Function Test
The Wolf Motor Function Test (WMFT) is a standardized tool for assessing upper limb motor function in stroke survivors (Wolf et al., 2001). It includes 17 tasks: 15 timed functional activities (e.g., lifting objects, stacking) and 2 strength measures (grip and pinch). It evaluates movement speed, function, and quality, with performance rated on a 6-point scale (0-5) and faster times indicating better ability. The WMFT has high reliability (ICC > 0.90) and strong validity, correlating well with FMA and ARAT.
Measured: The assesment will be done at baseline and after completion of 8 weeks.
Fugl-Meyer Assessment - Upper Extremity
The Fugl-Meyer Assessment (FMA) is a widely used tool to measure motor impairment after stroke (Fugl-Meyer et al., 1975). It evaluates upper limb function including reflexes, coordination, and voluntary movement of the shoulder, elbow, wrist, and hand. The total score ranges up to 66, with higher scores indicating better motor recovery. Each item is scored from 0 to 2, and the sum reflects overall performance. It has excellent reliability (ICC > 0.95) and strong validity for tracking motor recovery over time.
Measured: The assesment will be done at baseline and after completion of 8 weeks.
Nine Hole Peg Test
The Nine-Hole Peg Test (NHPT) is a standardized, timed assessment used to measure fine motor dexterity of the upper limb (Mathiowetz et al., 1985). Participants place and remove nine pegs from a pegboard as quickly as possible, and performance is recorded in seconds. Lower completion time indicates better dexterity. It shows high reliability (ICC 0.88-0.99) and strong validity in stroke and other neurological conditions.
Measured: The assesment will be done at baseline and after completion of 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start15 Aug 2026 (estimated)
- Primary completion10 Feb 2027 (estimated)
- Study completion10 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study consists of two phases. Phase I (Development Phase)involves developing the mobile application content, translating it into Urdu, and validating it through expert review to ensure clinical accuracy and appropriateness. Phase II (Testing Phase) involves pilot testing to assess the app's feasibility, usability, and preliminary effectiveness, followed by a randomized controlled trial (RCT) to compare the effectiveness of the app-based rehabilitation program with conventional physiotherapy using standardized outcome measures.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lahore University of Biological and Applied Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07734818
- Sponsor's protocol ID
- UBAS/ERB/26/04/036 Haziqa
- Status last verified
- Jul 2026
- First submitted
- 24 Jul 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Malik AN, Afridi A, Rathore FA. Mobile Health (mHealth) Applications for Stroke Rehabilitation: A mini review. J Pak Med Assoc. 2024 Sep;74(9):1723-1726. doi: 10.47391/JPMA.24-74.
PubMed 39279090Cao W, Li A, Kadir AA, Chen J, Chen L, Li Q, Hassan II. Older adult stroke survivors' needs and perspectives of a stroke app: a qualitative study. BMC Geriatr. 2025 Mar 29;25(1):212. doi: 10.1186/s12877-025-05849-1.
PubMed 40158132
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of Mobile Application for Upper Limb Function in Stroke Survivors
- ClinicalTrials.gov ID
- NCT07734818
- Acronym / sponsor ID
- UBAS/ERB/26/04/036 Haziqa
- Conditions
- Stroke
- Keywords
- Mobile application, Stroke survivors, Stroke rehabilitation for upper limb, stroke rehabilitation, personalized interventions, technology integration
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Lahore University of Biological and Applied SciencesUniversity, hospital or other
- Study start
- 15 Aug 2026 (estimated)
- Primary completion
- 10 Feb 2027 (estimated)
- Study completion
- 10 Feb 2027 (estimated)
- First posted
- 29 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study consists of two phases. Phase I (Development Phase)involves developing the mobile application content, translating it into Urdu, and validating it through expert review to ensure clinical accuracy and appropriateness. Phase II (Testing Phase) involves pilot testing to assess the app's feasibility, usability, and preliminary effectiveness, followed by a randomized controlled trial (RCT) to compare the effectiveness of the app-based rehabilitation program with conventional physiotherapy using standardized outcome measures.
| Arm | Type | Receives |
|---|---|---|
| Clinical Exercise group | Active comparator | Other: Routine Physical TherapyParticipants 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: mhealthParticipants 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. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mhealthProgressive Training Plan (8 Weeks) Phase I (Weeks 1-4): ROM \& Early Activation: * Passive, active-assisted, and active range of motion exercises for shoulder, elbow, wrist, and hand * Light strengthening with TheraBand and scapular stabilization * Basic task practice (reaching, grasping, releasing objects) Dose:2-3 sets of 8-10 reps (tasks: 10-15 reps), rest 60-90 sec Focus: Improve mobility, reduce stiffness, and activate muscles Phase II (Weeks 5-8): Strengthening \& Functional Training: * Progressive resistance training for upper limb muscles * Hand grip and pinch strengthening * Advanced functional tasks (pegboard, object transfer, ADL simulation, bilateral activities) Dose:3-4 sets of 12-15 reps (tasks: 20-30 reps), rest 60-90 sec Focus: Increase strength, coordination, endurance, and functional recovery | Device | m Health |
| Routine Physical TherapyRange-of-Motion Exercises: Include passive, active-assisted, and active movements of the shoulder, elbow, wrist, and fingers along with stretching to maintain joint mobility and reduce stiffness. Strengthening Exercises: Involve resisted upper limb exercises using TheraBands, weights, and therapy tools to improve shoulder, elbow, forearm, wrist, and hand strength, including grip and pinch strengthening. Task-Specific Functional Activities: Focus on functional and daily-life tasks such as reaching, grasping, object manipulation, pegboard tasks, ADL simulations, fine motor activities, and repetitive bilateral upper-limb training to enhance coordination and motor recovery. | Other | Clinical Exercise group |
Primary outcome
Wolf Motor Function Test
Time frame: The assesment will be done at baseline and after completion of 8 weeks.
The Wolf Motor Function Test (WMFT) is a standardized tool for assessing upper limb motor function in stroke survivors (Wolf et al., 2001). It includes 17 tasks: 15 timed functional activities (e.g., lifting objects, stacking) and 2 strength measures (grip and pinch). It evaluates movement speed, function, and quality, with performance rated on a 6-point scale (0-5) and faster times indicating better ability. The WMFT has high reliability (ICC > 0.90) and strong validity, correlating well with FMA and ARAT.
Fugl-Meyer Assessment - Upper Extremity
Time frame: The assesment will be done at baseline and after completion of 8 weeks.
The Fugl-Meyer Assessment (FMA) is a widely used tool to measure motor impairment after stroke (Fugl-Meyer et al., 1975). It evaluates upper limb function including reflexes, coordination, and voluntary movement of the shoulder, elbow, wrist, and hand. The total score ranges up to 66, with higher scores indicating better motor recovery. Each item is scored from 0 to 2, and the sum reflects overall performance. It has excellent reliability (ICC > 0.95) and strong validity for tracking motor recovery over time.
Nine Hole Peg Test
Time frame: The assesment will be done at baseline and after completion of 8 weeks.
The Nine-Hole Peg Test (NHPT) is a standardized, timed assessment used to measure fine motor dexterity of the upper limb (Mathiowetz et al., 1985). Participants place and remove nine pegs from a pegboard as quickly as possible, and performance is recorded in seconds. Lower completion time indicates better dexterity. It shows high reliability (ICC 0.88-0.99) and strong validity in stroke and other neurological conditions.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Results publication: PubMed 39279090Malik AN, Afridi A, Rathore FA. Mobile Health (mHealth) Applications for Stroke Rehabilitation: A mini review. J Pak Med Assoc. 2024 Sep;74(9):1723-1726. doi: 10.47391/JPMA.24-74.
- Results publication: PubMed 40158132Cao W, Li A, Kadir AA, Chen J, Chen L, Li Q, Hassan II. Older adult stroke survivors' needs and perspectives of a stroke app: a qualitative study. BMC Geriatr. 2025 Mar 29;25(1):212. doi: 10.1186/s12877-025-05849-1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mhealth and Routine Physical Therapy in people with Stroke, run by Lahore University of Biological and Applied Sciences at 2 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haziqa Pari, MSNMPT (+923044516865, haziqamalik44@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wolf Motor Function Test (time frame: The assesment will be done at baseline and after completion of 8 weeks.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07734818, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.