StrokeCIMT-HABITNCT07626554
CIMT Versus HABIT in Late Sub-Acute Post-Stroke Rehabilitation
A study testing Constraint Induced Movement Therapy and Hand-Arm Bimanual Intensive Training in people with Stroke, run by Riphah International University at 1 site in Pakistan.
Trial summary
This study will compare the effects of Constraint Induced Movement Therapy and Hand-Arm Bimanual Intensive Training on upper extremity function in late sub-acute post-stroke patients. It will be a randomized controlled trial. Eligible participants will be randomly allocated into two groups. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Constraint Induced Movement Therapy and Hand-Arm Bimanual Intensive Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 sitePakistan
- Study dates
- 5 Jun 2025to 6 Aug 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 40 years and above.
- Diagnosed with unilateral ischemic or hemorrhagic stroke.
- Stroke duration between 3 to 6 months.
- Mini-Mental State Examination score of 24 or above.
- Able and willing to provide informed consent.
Who cannot join
- Severe pain in the more affected upper limb on verbal rating scale.
- Spasticity greater than 3 on the Modified Ashworth Scale in the affected upper limb.
- Unstable cardiovascular conditions.
- Any traumatic musculoskeletal injury of the upper limb.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Riphah College of Rehabilitation Sciences
Lahore, Punjab Province, 55100
About this study
Official title: Comparative Effects of Constraint Induced Movement Therapy and Hand-Arm Bimanual Intensive Training for Upper Extremity Function in Late Sub-Acute Post-Stroke Patients
This study will compare the effects of Constraint Induced Movement Therapy and Hand-Arm Bimanual Intensive Training on upper extremity function in late sub-acute post-stroke patients. It will be a randomized controlled trial. Eligible participants will be randomly allocated into two groups. One group will receive Constraint Induced Movement Therapy, while the other group will receive Hand-Arm Bimanual Intensive Training. Both groups will also receive standard physiotherapy for mobility and postural control. The intervention will continue for 3 weeks. Outcomes will be assessed at baseline and after the intervention using upper limb function and motor control assessment tools.
Read the detailed description
Stroke commonly affects upper extremity function and may reduce a patient's ability to perform daily activities independently. In the late sub-acute phase after stroke, structured rehabilitation may help improve arm and hand function, motor control, and real-world use of the affected upper limb. Constraint Induced Movement Therapy encourages use of the affected upper limb by restricting the unaffected arm and providing intensive task-oriented training. Hand-Arm Bimanual Intensive Training focuses on coordinated use of both hands through functional bimanual tasks. This study will compare these two rehabilitation approaches in late sub-acute post-stroke patients. Findings may help guide evidence-based selection of upper limb rehabilitation strategies for improving functional recovery after stroke.
- Conditions
- Stroke
- Being tested
- Constraint Induced Movement Therapy, Hand-Arm Bimanual Intensive Training
- 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 TherapyBehavioural
Also called CIMT
Constraint Induced Movement Therapy will be provided for 3 weeks. The unaffected upper limb will be constrained with a mitt for 90% of waking hours. Participants will receive intensive task-oriented training of the affected upper limb for 2 hours per day, 5 days per week. Activities will include reaching, grasping, manipulating objects, dressing, and eating tasks. Standard physiotherapy for mobility and postural control will also be provided.
Hand-Arm Bimanual Intensive TrainingBehavioural
Hand-Arm Bimanual Intensive Training will be provided for 3 weeks. Participants will receive supervised bimanual upper limb training for 2 hours per day, 5 days per week. Activities will include symmetrical and asymmetrical bilateral tasks such as folding clothes, pouring water, object transfer, and coordinated hand use. Standard physiotherapy for mobility and postural control will also be provided.
| Study group | Role | What they receive |
|---|---|---|
| Constraint Induced Movement Therapy Group | Experimental | Participants in this arm will receive Constraint Induced Movement Therapy for 3 weeks. The unaffected arm will be constrained with a mitt for 90% of waking hours, and the affected arm will receive intensive task-oriented training for 2 hours per day, 5 days per week. Training tasks will include reaching, grasping, manipulating, dressing, and eating activities. Participants will also receive standard physiotherapy for mobility and postural control. Receives: Behavioral: Constraint Induced Movement Therapy |
| Hand-Arm Bimanual Intensive Training Group | Active comparator | Participants in this arm will receive Hand-Arm Bimanual Intensive Training for 3 weeks. Training will be provided for 2 hours per day, 5 days per week, using symmetrical and asymmetrical bimanual activities such as folding clothes and pouring water. Participants will also receive standard physiotherapy for mobility and postural control. Receives: Behavioral: Hand-Arm Bimanual Intensive Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment - Upper Extremity (FMA-UE)
Measures motor recovery and voluntary movement of the affected upper limb after stroke.
Measured: Baseline and Week 3 (Post-intervention)
Action Research Arm Test (ARAT)
Assesses upper extremity functional ability including grasp, grip, pinch, and gross movement.
Measured: Baseline and Week 3 (Post-intervention)
Secondary outcomes (4)
Motor Activity Log (MAL)
Evaluates real-world use of the affected arm including Amount of Use and Quality of Movement.
Measured: Baseline and Week 3
Box and Block Test (BBT)
Assesses gross manual dexterity by counting blocks transferred within 60 seconds.
Measured: Baseline and Week 3
Jebsen-Taylor Hand Function Test (JTHFT)
Measures functional hand performance during simulated daily activities.
Measured: Baseline and Week 3
Adult Assisting Hand Assessment (Ad-AHA)
Measures effectiveness of affected hand use during bimanual task performance.
Measured: Baseline and Week 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start5 Jun 2025
- Primary completion6 Jul 2026 (estimated)
- Study completion6 Aug 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.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Model description
- participants will be randomly allocated into two groups: Constraint Induced Movement Therapy group and Hand-Arm Bimanual Intensive Training group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ambreen I IQBAL, Study chair, Riphah International University Role
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07626554
- Sponsor's protocol ID
- HAFSA LATIF
- Acronym
- CIMT-HABIT
- Status last verified
- Jun 2026
- First submitted
- 1 Jun 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because no formal data-sharing mechanism or repository has been established for this academic study. Participant confidentiality and privacy will be maintained.
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Constraint Induced Movement Therapy and Hand-Arm Bimanual Intensive Training for Upper Extremity Function in Late Sub-Acute Post-Stroke Patients
- ClinicalTrials.gov ID
- NCT07626554
- Acronym / sponsor ID
- CIMT-HABIT / HAFSA LATIF
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 5 Jun 2025 (actual)
- Primary completion
- 6 Jul 2026 (estimated)
- Study completion
- 6 Aug 2026 (estimated)
- First posted
- 4 Jun 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.
This study will compare the effects of Constraint Induced Movement Therapy and Hand-Arm Bimanual Intensive Training on upper extremity function in late sub-acute post-stroke patients. It will be a randomized controlled trial. Eligible participants will be randomly allocated into two groups. One group will receive Constraint Induced Movement Therapy, while the other group will receive Hand-Arm Bimanual Intensive Training. Both groups will also receive standard physiotherapy for mobility and postural control. The intervention will continue for 3 weeks. Outcomes will be assessed at baseline and after the intervention using upper limb function and motor control assessment tools.
Detailed description
Stroke commonly affects upper extremity function and may reduce a patient's ability to perform daily activities independently. In the late sub-acute phase after stroke, structured rehabilitation may help improve arm and hand function, motor control, and real-world use of the affected upper limb. Constraint Induced Movement Therapy encourages use of the affected upper limb by restricting the unaffected arm and providing intensive task-oriented training. Hand-Arm Bimanual Intensive Training focuses on coordinated use of both hands through functional bimanual tasks. This study will compare these two rehabilitation approaches in late sub-acute post-stroke patients. Findings may help guide evidence-based selection of upper limb rehabilitation strategies for improving functional recovery after stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- participants will be randomly allocated into two groups: Constraint Induced Movement Therapy group and Hand-Arm Bimanual Intensive Training group.
| Arm | Type | Receives |
|---|---|---|
| Constraint Induced Movement Therapy Group | Experimental | Behavioral: Constraint Induced Movement TherapyParticipants in this arm will receive Constraint Induced Movement Therapy for 3 weeks. The unaffected arm will be constrained with a mitt for 90% of waking hours, and the affected arm will receive intensive task-oriented training for 2 hours per day, 5 days per week. Training tasks will include reaching, grasping, manipulating, dressing, and eating activities. Participants will also receive standard physiotherapy for mobility and postural control. |
| Hand-Arm Bimanual Intensive Training Group | Active comparator | Behavioral: Hand-Arm Bimanual Intensive TrainingParticipants in this arm will receive Hand-Arm Bimanual Intensive Training for 3 weeks. Training will be provided for 2 hours per day, 5 days per week, using symmetrical and asymmetrical bimanual activities such as folding clothes and pouring water. Participants will also receive standard physiotherapy for mobility and postural control. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 40 years and above.
- Diagnosed with unilateral ischemic or hemorrhagic stroke.
- Stroke duration between 3 to 6 months.
- Mini-Mental State Examination score of 24 or above.
- Able and willing to provide informed consent.
Key exclusion criteria (4 listed)
- Severe pain in the more affected upper limb on verbal rating scale.
- Spasticity greater than 3 on the Modified Ashworth Scale in the affected upper limb.
- Unstable cardiovascular conditions.
- Any traumatic musculoskeletal injury of 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 |
|---|---|---|
| Constraint Induced Movement TherapyAlso: CIMTConstraint Induced Movement Therapy will be provided for 3 weeks. The unaffected upper limb will be constrained with a mitt for 90% of waking hours. Participants will receive intensive task-oriented training of the affected upper limb for 2 hours per day, 5 days per week. Activities will include reaching, grasping, manipulating objects, dressing, and eating tasks. Standard physiotherapy for mobility and postural control will also be provided. | Behavioural | Constraint Induced Movement Therapy Group |
| Hand-Arm Bimanual Intensive TrainingHand-Arm Bimanual Intensive Training will be provided for 3 weeks. Participants will receive supervised bimanual upper limb training for 2 hours per day, 5 days per week. Activities will include symmetrical and asymmetrical bilateral tasks such as folding clothes, pouring water, object transfer, and coordinated hand use. Standard physiotherapy for mobility and postural control will also be provided. | Behavioural | Hand-Arm Bimanual Intensive Training Group |
Primary outcome
Fugl-Meyer Assessment - Upper Extremity (FMA-UE)
Time frame: Baseline and Week 3 (Post-intervention)
Measures motor recovery and voluntary movement of the affected upper limb after stroke.
Action Research Arm Test (ARAT)
Time frame: Baseline and Week 3 (Post-intervention)
Assesses upper extremity functional ability including grasp, grip, pinch, and gross movement.
4 secondary outcomes
Motor Activity Log (MAL)
Time frame: Baseline and Week 3
Box and Block Test (BBT)
Time frame: Baseline and Week 3
Jebsen-Taylor Hand Function Test (JTHFT)
Time frame: Baseline and Week 3
Adult Assisting Hand Assessment (Ad-AHA)
Time frame: Baseline and Week 3
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 4 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because no formal data-sharing mechanism or repository has been established for this academic study. Participant confidentiality and privacy will be maintained.
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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. This study is not recruiting at the moment.
Ambreen I IQBAL study chair
Riphah International University Role
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 and Hand-Arm Bimanual Intensive Training in people with Stroke, run by Riphah International University 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 5 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 4 Jun 2026. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer Assessment - Upper Extremity (FMA-UE) (time frame: Baseline and Week 3 (Post-intervention)). The study lists 2 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 4 Jun 2026.