StrokeCR vs CIMTNCT07093983
Comparing Two Therapies to Improve Arm Function After Stroke
A study testing Constraint-Induced Movement Therapy (CIMT) and Coupling Rehabilitation in people with Stroke, run by University of Lahore at 1 site in Pakistan.
Trial summary
This clinical trial aims to compare the effects of coupling rehabilitation and constraint-induced movement therapy (CIMT) on improving arm function, hand skills, and daily activity performance in people who have upper limb weakness after a stroke. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Stroke
- What is being tested?
- Constraint-Induced Movement Therapy (CIMT) and Coupling Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 sitePakistan
- Study dates
- 5 Aug 2025to 1 May 2026
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients suffering from Sub acute stroke
- Motor function score at Fugl-Meyer Assessment between 40-60
- Fine motor assessment at Box and Block Test<20
- ADL's assessment at Motor Activity Log:
- Amount of use scale<2.5 Quality of movement scale<3
- -
Who cannot join
- Individuals suffering from unstable angina, symptomatic heart failure, or uncontrolled hypertension
- Physician determined unstable cardiovascular conditions
- The patient has been diagnosed as having organ failure, including the heart, kidneys, and lungs
- Patients with any traumatic musculoskeletal injury to upper limbs
- Individuals who are experiencing cognitive impairment as a result of neurological conditions other than stroke.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ayesha Jamil, BSPT, TDPT, M PHIL. PT contact
Pakistan1 site
University of Lahore Teaching Hospital
Lahore, Punjab Province, 54600
Laraib Akbar, MSPTN, +923056926352, laraibakbar9@gmail.com
About this study
Official title: Coupling Rehabilitation Versus Constraint Induced Movement Therapy in Post Stroke Patients With Upper Limb Impairment
This clinical trial aims to compare the effects of coupling rehabilitation and constraint-induced movement therapy (CIMT) on improving arm function, hand skills, and daily activity performance in people who have upper limb weakness after a stroke. Participants will be randomly assigned to one of two groups and receive 12 weeks of therapy, including either CIMT or coupling rehabilitation along with conventional physical therapy. The study will evaluate which method is more effective in restoring movement and independence by using standardized assessments before, during, and after the intervention. The findings may help guide future rehabilitation approaches for stroke survivors
Read the detailed description
This study focuses on improving upper limb recovery in people who have experienced a stroke. Stroke often leads to long-term weakness or difficulty using one arm, which can limit a person's ability to perform everyday tasks such as dressing, eating, or writing. The study explores two promising rehabilitation strategies-Constraint-Induced Movement Therapy (CIMT) and Coupling Rehabilitation-that may help improve arm movement, hand coordination, and independence in daily life.
Participants will take part in therapy sessions over a 12-week period, during which they will engage in structured, goal-oriented exercises tailored to their physical abilities. The research team will monitor changes in motor function and hand dexterity through standard assessments administered at the beginning, mid-point, and end of the study. By comparing outcomes between the two groups, the study seeks to identify which therapy method is more effective in promoting functional recovery after stroke, with the goal of enhancing rehabilitation practices in clinical settings.
- Conditions
- Stroke
- Being tested
- Constraint-Induced Movement Therapy (CIMT), Coupling Rehabilitation
- Keywords
- CouplingRehabilitation, CIMT, Stroke, impairment
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Constraint-Induced Movement Therapy (CIMT)Other
Participants in this group will receive modified CIMT in combination with conventional physical therapy. The unaffected arm will be restrained to encourage use of the affected upper limb. Task-specific exercises will include fine motor tasks, strengthening, reaching, and functional movement training. Each session will last approximately 45-60 minutes and will be conducted three times per week for 12 weeks.
Coupling RehabilitationOther
Participants in this group will receive Coupling Rehabilitation in addition to conventional physical therapy. This method involves bilateral arm training and functional tasks designed to improve coordination between both upper limbs, using the unaffected limb to guide movement in the affected one. Exercises will include trunk-supported reaching, object retrieval, and posture-supported task practice. Sessions will occur three times per week for 12 weeks, each lasting approximately 45-60 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Constraint-Induced Movement Therapy (CIMT) Group | Experimental | Participants in this group will receive Constraint-Induced Movement Therapy (CIMT) along with conventional physical therapy. CIMT involves structured, task-specific exercises that focus on improving the use of the affected upper limb by restricting the unaffected arm. Sessions will include activities such as fine motor training, reaching tasks, strengthening exercises, and functional movement tasks. Therapy will be delivered three times per week for 12 weeks. Receives: Other: Constraint-Induced Movement Therapy (CIMT) |
| Coupling Rehabilitation Group | Experimental | Participants in this group will receive Coupling Rehabilitation along with conventional physical therapy. Coupling Rehabilitation involves bilateral arm training and task-specific activities that encourage coordinated use of both upper limbs to stimulate recovery in the affected arm. Exercises will include trunk-supported reaching, object manipulation, and simulated daily tasks. Therapy will be provided three times per week for 12 weeks. Receives: Other: Coupling Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Upper Limb Motor Function Using the Fugl-Meyer Assessment (FMA)
This outcome assesses changes in motor control and function of the affected upper limb using the Fugl-Meyer Assessment, a validated stroke-specific performance test. Higher scores reflect better motor recovery.
Measured: Baseline, 6 weeks, and 12 weeks after start of intervention
Change in Hand Dexterity Using the Box and Block Test (BBT)
This outcome evaluates fine motor skills and hand coordination by measuring the number of blocks a participant can move from one compartment to another in one minute using the affected hand. Higher scores indicate better hand dexterity.
Measured: Baseline, 6 weeks, and 12 weeks after start of intervention
Change in Performance of Daily Activities Using the Motor Activity Log (MAL)
This outcome assesses real-world use of the affected upper limb in daily activities using the MAL questionnaire. It includes two subscales: Amount of Use (AOU) and Quality of Movement (QOM). Higher scores indicate better function and limb use.
Measured: Baseline, 6 weeks, and 12 weeks after start of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start5 Aug 2025 (estimated)
- Primary completion1 Apr 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maryam Shabbir, PH.D. PT, Principal investigator, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07093983
- Sponsor's protocol ID
- LARAIB AKBAR
- Acronym
- CR vs CIMT
- Status last verified
- Jul 2025
- First submitted
- 22 Jul 2025
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coupling Rehabilitation Versus Constraint Induced Movement Therapy in Post Stroke Patients With Upper Limb Impairment
- ClinicalTrials.gov ID
- NCT07093983
- Acronym / sponsor ID
- CR vs CIMT / LARAIB AKBAR
- Conditions
- Stroke
- Keywords
- CouplingRehabilitation, CIMT, Stroke, impairment
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 5 Aug 2025 (estimated)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 30 Jul 2025 (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.
This clinical trial aims to compare the effects of coupling rehabilitation and constraint-induced movement therapy (CIMT) on improving arm function, hand skills, and daily activity performance in people who have upper limb weakness after a stroke. Participants will be randomly assigned to one of two groups and receive 12 weeks of therapy, including either CIMT or coupling rehabilitation along with conventional physical therapy. The study will evaluate which method is more effective in restoring movement and independence by using standardized assessments before, during, and after the intervention. The findings may help guide future rehabilitation approaches for stroke survivors
Detailed description
This study focuses on improving upper limb recovery in people who have experienced a stroke. Stroke often leads to long-term weakness or difficulty using one arm, which can limit a person's ability to perform everyday tasks such as dressing, eating, or writing. The study explores two promising rehabilitation strategies-Constraint-Induced Movement Therapy (CIMT) and Coupling Rehabilitation-that may help improve arm movement, hand coordination, and independence in daily life.
Participants will take part in therapy sessions over a 12-week period, during which they will engage in structured, goal-oriented exercises tailored to their physical abilities. The research team will monitor changes in motor function and hand dexterity through standard assessments administered at the beginning, mid-point, and end of the study. By comparing outcomes between the two groups, the study seeks to identify which therapy method is more effective in promoting functional recovery after stroke, with the goal of enhancing rehabilitation practices in clinical settings.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Constraint-Induced Movement Therapy (CIMT) Group | Experimental | Other: Constraint-Induced Movement Therapy (CIMT)Participants in this group will receive Constraint-Induced Movement Therapy (CIMT) along with conventional physical therapy. CIMT involves structured, task-specific exercises that focus on improving the use of the affected upper limb by restricting the unaffected arm. Sessions will include activities such as fine motor training, reaching tasks, strengthening exercises, and functional movement tasks. Therapy will be delivered three times per week for 12 weeks. |
| Coupling Rehabilitation Group | Experimental | Other: Coupling RehabilitationParticipants in this group will receive Coupling Rehabilitation along with conventional physical therapy. Coupling Rehabilitation involves bilateral arm training and task-specific activities that encourage coordinated use of both upper limbs to stimulate recovery in the affected arm. Exercises will include trunk-supported reaching, object manipulation, and simulated daily tasks. Therapy will be provided three times per week for 12 weeks. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients suffering from Sub acute stroke
- Motor function score at Fugl-Meyer Assessment between 40-60
- Fine motor assessment at Box and Block Test<20
- ADL's assessment at Motor Activity Log:
- Amount of use scale<2.5 Quality of movement scale<3
Key exclusion criteria (5 listed)
- Individuals suffering from unstable angina, symptomatic heart failure, or uncontrolled hypertension
- Physician determined unstable cardiovascular conditions
- The patient has been diagnosed as having organ failure, including the heart, kidneys, and lungs
- Patients with any traumatic musculoskeletal injury to upper limbs
- Individuals who are experiencing cognitive impairment as a result of neurological conditions other than stroke.
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 |
|---|---|---|
| Constraint-Induced Movement Therapy (CIMT)Participants in this group will receive modified CIMT in combination with conventional physical therapy. The unaffected arm will be restrained to encourage use of the affected upper limb. Task-specific exercises will include fine motor tasks, strengthening, reaching, and functional movement training. Each session will last approximately 45-60 minutes and will be conducted three times per week for 12 weeks. | Other | Constraint-Induced Movement Therapy (CIMT) Group |
| Coupling RehabilitationParticipants in this group will receive Coupling Rehabilitation in addition to conventional physical therapy. This method involves bilateral arm training and functional tasks designed to improve coordination between both upper limbs, using the unaffected limb to guide movement in the affected one. Exercises will include trunk-supported reaching, object retrieval, and posture-supported task practice. Sessions will occur three times per week for 12 weeks, each lasting approximately 45-60 minutes. | Other | Coupling Rehabilitation Group |
Primary outcome
Improvement in Upper Limb Motor Function Using the Fugl-Meyer Assessment (FMA)
Time frame: Baseline, 6 weeks, and 12 weeks after start of intervention
This outcome assesses changes in motor control and function of the affected upper limb using the Fugl-Meyer Assessment, a validated stroke-specific performance test. Higher scores reflect better motor recovery.
Change in Hand Dexterity Using the Box and Block Test (BBT)
Time frame: Baseline, 6 weeks, and 12 weeks after start of intervention
This outcome evaluates fine motor skills and hand coordination by measuring the number of blocks a participant can move from one compartment to another in one minute using the affected hand. Higher scores indicate better hand dexterity.
Change in Performance of Daily Activities Using the Motor Activity Log (MAL)
Time frame: Baseline, 6 weeks, and 12 weeks after start of intervention
This outcome assesses real-world use of the affected upper limb in daily activities using the MAL questionnaire. It includes two subscales: Amount of Use (AOU) and Quality of Movement (QOM). Higher scores indicate better function and limb use.
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 3 Aug 2025.
- Individual participant dataSharing planned: Yes
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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.
Ayesha Jamil, BSPT, TDPT, M PHIL. PT contact
Maryam Shabbir, PH.D. PT principal investigator
University of Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Constraint-Induced Movement Therapy (CIMT) and Coupling Rehabilitation in people with Stroke, run by University of Lahore at 1 site 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 6 inclusion and 5 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 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Laraib Akbar, MSPTN (+923056926352, laraibakbar9@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in Upper Limb Motor Function Using the Fugl-Meyer Assessment (FMA) (time frame: Baseline, 6 weeks, and 12 weeks after start of intervention). 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?
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 3 Aug 2025.