Chronic StrokeCIMT-BTNCT07378774
Constraint Induced Movement Therapy and Bilateral Training in Chronic Stroke
A study testing CIMT and bilateral training in people with Chronic Stroke, run by Zikra Azhar at 1 site in Pakistan.
Trial summary
Stroke is a leading cause of long-term disability, with upper limb spasticity and impaired hand function being common problems in the chronic phase. These impairments significantly affect independence in activities of daily living and overall quality of life. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Stroke
- What is being tested?
- CIMT and bilateral training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 sitePakistan
- Study dates
- 5 Feb 2026to 6 Apr 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with stroke in chronic phase. Patients with normal cognition (MMS 21 and above) Both male and female patients will be included. Adult patients will be included. (age 18-65) Participants with spasticity score of 2 or less on MAS.
Who cannot join
- Acute and other neurological and musculoskeletal conditions e.g. Parkinson's, multiple sclerosis. Patients who do not agree to treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Shadman Medical Center
Lahore, Punjab Province, 54000
Zikra Azhar, MSPT N, 03446928620, zikraazhar4@gmail.com
Montiha Azeem, MSPTN, 03479717317, muntahaazeem9@gmail.com
About this study
Official title: Constraint-Induced Movement Therapy and Bilateral Training in Chronic Stroke
Stroke is a leading cause of long-term disability, with upper limb spasticity and impaired hand function being common problems in the chronic phase. These impairments significantly affect independence in activities of daily living and overall quality of life. Constraint-Induced Movement Therapy (CIMT) and Bilateral Training (BT) are two widely used neurorehabilitation approaches aimed at improving upper limb motor recovery after stroke; however, evidence comparing their effectiveness on wrist spasticity and hand function in chronic stroke patients remains limited.
This single-blinded randomized controlled trial aims to compare the effects of Constraint-Induced Movement Therapy combined with Functional Electrical Stimulation (FES) versus Bilateral Training combined with Functional Electrical Stimulation on wrist spasticity and hand function in patients with chronic stroke. A total of 94 participants diagnosed with chronic stroke will be randomly allocated into two groups. Group A will receive CIMT with FES, while Group B will receive Bilateral Training with FES. Both interventions will be administered three times per week for eight weeks.
Read more
Outcome measures will include wrist spasticity assessed using the Modified Ashworth Scale (MAS) and upper limb motor function assessed using the Fugl-Meyer Assessment for Upper Extremity (FMA-UE) and the Chedoke Arm and Hand Activity Inventory (CAHAI). Assessments will be conducted at baseline and after completion of the intervention period.
The findings of this study are expected to provide evidence on the comparative effectiveness of CIMT and Bilateral Training in improving wrist spasticity and hand function, thereby assisting clinicians in selecting optimal rehabilitation strategies for chronic stroke patients.
Read the detailed description
This study is designed as a single-blinded randomized controlled trial to evaluate and compare the therapeutic effects of Constraint-Induced Movement Therapy (CIMT) and Bilateral Training (BT), both combined with Functional Electrical Stimulation (FES), on wrist spasticity and hand function in individuals with chronic stroke. Upper limb motor impairment and spasticity are major contributors to functional disability in stroke survivors, particularly in the chronic stage where spontaneous recovery is minimal and structured rehabilitation becomes essential.
Eligible participants with chronic stroke will be recruited from tertiary care hospitals and rehabilitation centers. After obtaining informed consent, participants will be randomly assigned to one of two intervention groups using a computer-generated randomization method. Outcome assessors will remain blinded to group allocation to minimize assessment bias.
Group A will receive CIMT combined with FES. CIMT will involve restraining the non-affected upper limb to encourage intensive use of the affected limb during functional and task-specific activities. Functional Electrical Stimulation will be applied to the wrist extensor muscles to facilitate muscle activation, improve motor control, and reduce spasticity.
Group B will receive Bilateral Training combined with FES. Bilateral Training will emphasize simultaneous use of both upper limbs through symmetrical and functional task-oriented activities to enhance interhemispheric coordination and promote neuroplasticity. FES parameters will remain consistent across both groups to ensure intervention standardization.
Both groups will receive therapy sessions three times per week for eight weeks, following the FITT principle. Outcome measures will be recorded at baseline and after completion of the intervention protocol. Wrist spasticity will be assessed using the Modified Ashworth Scale, while upper limb motor recovery and hand function will be evaluated using the Fugl-Meyer Assessment for Upper Extremity and the Chedoke Arm and Hand Activity Inventory.
This study aims to generate clinically relevant evidence to determine which rehabilitation approach offers superior outcomes in reducing spasticity and improving hand function in chronic stroke patients.
- Conditions
- Chronic Stroke
- Being tested
- CIMT, bilateral training
- Keywords
- Chronic stroke, Constraint-induced movement therapy, Bilateral training, Upper limb rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CIMTBehavioural
Also called Constrain induced movement therapy
Constraint-Induced Movement Therapy (CIMT) will be administered by restraining the non-affected upper limb using a mitt or glove to promote active use of the affected limb. Participants will perform task-oriented and functional activities such as grasping, releasing, reaching, object manipulation, and activities of daily living using the affected upper limb. Training intensity will be progressively increased based on patient performance. Functional Electrical Stimulation (FES) will be applied to the wrist extensor muscles (extensor carpi radialis longus and brevis) to facilitate muscle contraction, reduce spasticity, and enhance motor relearning. Sessions will be conducted three times per week for eight weeks.
bilateral trainingBehavioural
Bilateral Training will involve simultaneous use of both upper limbs to perform symmetrical and functional task-based activities designed to improve coordination and motor control of the affected upper limb. Exercises will progress from simple bilateral movements to complex functional tasks such as lifting objects, folding towels, and opening containers. Functional Electrical Stimulation (FES) will be applied to the wrist extensor muscles using the same stimulation parameters as the experimental intervention to ensure consistency. Therapy will be delivered three times per week for eight weeks.
| Study group | Role | What they receive |
|---|---|---|
| group A CIMT | Experimental | Participants in this arm will receive Constraint-Induced Movement Therapy combined with Functional Electrical Stimulation (FES). The non-affected upper limb will be restrained using a mitt or glove to encourage use of the affected limb during therapy sessions. Task-oriented and functional activities focusing on grasping, releasing, reaching, and object manipulation will be practiced with the affected upper limb. Functional Electrical Stimulation will be applied to the wrist extensor muscles to facilitate muscle activation, reduce spasticity, and enhance motor recovery. Therapy will be provided three sessions per week for eight weeks. Receives: Behavioral: CIMT |
| group B bilateral training | Active comparator | Participants in this arm will receive Bilateral Training combined with Functional Electrical Stimulation (FES). Therapy will involve simultaneous use of both upper limbs to perform symmetrical and functional task-based activities aimed at improving coordination and motor control of the affected limb. Tasks will progress from simple bilateral movements to functional activities involving both hands. Functional Electrical Stimulation will be applied to the wrist extensor muscles using the same parameters as the experimental group. Therapy will be delivered three sessions per week for eight weeks. Receives: Behavioral: bilateral training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Wrist Spasticity
Wrist spasticity will be assessed using the Modified Ashworth Scale (MAS), which grades resistance to passive movement from 0 (no increase in muscle tone) to 4 (rigid limb).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start5 Feb 2026 (estimated)
- Primary completion5 Apr 2026 (estimated)
- Study completion6 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zikra Azhar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zikra Azhar, University of Lahore
- Investigators
- Zikra Azhar, MSPTN, Principal investigator, The University of Lahore, Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07378774
- Sponsor's protocol ID
- UOL/IREB/25/15/03/40
- Acronym
- CIMT-BT
- Status last verified
- Jan 2026
- First submitted
- 22 Jan 2026
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Constraint-Induced Movement Therapy and Bilateral Training in Chronic Stroke
- ClinicalTrials.gov ID
- NCT07378774
- Acronym / sponsor ID
- CIMT-BT / UOL/IREB/25/15/03/40
- Conditions
- Chronic Stroke
- Keywords
- Chronic stroke, Constraint-induced movement therapy, Bilateral training, Upper limb rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- Zikra AzharUniversity, hospital or other
- Study start
- 5 Feb 2026 (estimated)
- Primary completion
- 5 Apr 2026 (estimated)
- Study completion
- 6 Apr 2026 (estimated)
- First posted
- 30 Jan 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.
Stroke is a leading cause of long-term disability, with upper limb spasticity and impaired hand function being common problems in the chronic phase. These impairments significantly affect independence in activities of daily living and overall quality of life. Constraint-Induced Movement Therapy (CIMT) and Bilateral Training (BT) are two widely used neurorehabilitation approaches aimed at improving upper limb motor recovery after stroke; however, evidence comparing their effectiveness on wrist spasticity and hand function in chronic stroke patients remains limited.
This single-blinded randomized controlled trial aims to compare the effects of Constraint-Induced Movement Therapy combined with Functional Electrical Stimulation (FES) versus Bilateral Training combined with Functional Electrical Stimulation on wrist spasticity and hand function in patients with chronic stroke. A total of 94 participants diagnosed with chronic stroke will be randomly allocated into two groups. Group A will receive CIMT with FES, while Group B will receive Bilateral Training with FES. Both interventions will be administered three times per week for eight weeks.
Outcome measures will include wrist spasticity assessed using the Modified Ashworth Scale (MAS) and upper limb motor function assessed using the Fugl-Meyer Assessment for Upper Extremity (FMA-UE) and the Chedoke Arm and Hand Activity Inventory (CAHAI). Assessments will be conducted at baseline and after completion of the intervention period.
The findings of this study are expected to provide evidence on the comparative effectiveness of CIMT and Bilateral Training in improving wrist spasticity and hand function, thereby assisting clinicians in selecting optimal rehabilitation strategies for chronic stroke patients.
Detailed description
This study is designed as a single-blinded randomized controlled trial to evaluate and compare the therapeutic effects of Constraint-Induced Movement Therapy (CIMT) and Bilateral Training (BT), both combined with Functional Electrical Stimulation (FES), on wrist spasticity and hand function in individuals with chronic stroke. Upper limb motor impairment and spasticity are major contributors to functional disability in stroke survivors, particularly in the chronic stage where spontaneous recovery is minimal and structured rehabilitation becomes essential.
Eligible participants with chronic stroke will be recruited from tertiary care hospitals and rehabilitation centers. After obtaining informed consent, participants will be randomly assigned to one of two intervention groups using a computer-generated randomization method. Outcome assessors will remain blinded to group allocation to minimize assessment bias.
Group A will receive CIMT combined with FES. CIMT will involve restraining the non-affected upper limb to encourage intensive use of the affected limb during functional and task-specific activities. Functional Electrical Stimulation will be applied to the wrist extensor muscles to facilitate muscle activation, improve motor control, and reduce spasticity.
Group B will receive Bilateral Training combined with FES. Bilateral Training will emphasize simultaneous use of both upper limbs through symmetrical and functional task-oriented activities to enhance interhemispheric coordination and promote neuroplasticity. FES parameters will remain consistent across both groups to ensure intervention standardization.
Both groups will receive therapy sessions three times per week for eight weeks, following the FITT principle. Outcome measures will be recorded at baseline and after completion of the intervention protocol. Wrist spasticity will be assessed using the Modified Ashworth Scale, while upper limb motor recovery and hand function will be evaluated using the Fugl-Meyer Assessment for Upper Extremity and the Chedoke Arm and Hand Activity Inventory.
This study aims to generate clinically relevant evidence to determine which rehabilitation approach offers superior outcomes in reducing spasticity and improving hand function in chronic stroke patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A CIMT | Experimental | Behavioral: CIMTParticipants in this arm will receive Constraint-Induced Movement Therapy combined with Functional Electrical Stimulation (FES). The non-affected upper limb will be restrained using a mitt or glove to encourage use of the affected limb during therapy sessions. Task-oriented and functional activities focusing on grasping, releasing, reaching, and object manipulation will be practiced with the affected upper limb. Functional Electrical Stimulation will be applied to the wrist extensor muscles to facilitate muscle activation, reduce spasticity, and enhance motor recovery. Therapy will be provided three sessions per week for eight weeks. |
| group B bilateral training | Active comparator | Behavioral: bilateral trainingParticipants in this arm will receive Bilateral Training combined with Functional Electrical Stimulation (FES). Therapy will involve simultaneous use of both upper limbs to perform symmetrical and functional task-based activities aimed at improving coordination and motor control of the affected limb. Tasks will progress from simple bilateral movements to functional activities involving both hands. Functional Electrical Stimulation will be applied to the wrist extensor muscles using the same parameters as the experimental group. Therapy will be delivered three sessions per week for eight weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients diagnosed with stroke in chronic phase. Patients with normal cognition (MMS 21 and above) Both male and female patients will be included. Adult patients will be included. (age 18-65) Participants with spasticity score of 2 or less on MAS.
Key exclusion criteria (1 listed)
- Acute and other neurological and musculoskeletal conditions e.g. Parkinson's, multiple sclerosis. Patients who do not agree to treatment.
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 |
|---|---|---|
| CIMTAlso: Constrain induced movement therapyConstraint-Induced Movement Therapy (CIMT) will be administered by restraining the non-affected upper limb using a mitt or glove to promote active use of the affected limb. Participants will perform task-oriented and functional activities such as grasping, releasing, reaching, object manipulation, and activities of daily living using the affected upper limb. Training intensity will be progressively increased based on patient performance. Functional Electrical Stimulation (FES) will be applied to the wrist extensor muscles (extensor carpi radialis longus and brevis) to facilitate muscle contraction, reduce spasticity, and enhance motor relearning. Sessions will be conducted three times per week for eight weeks. | Behavioural | group A CIMT |
| bilateral trainingBilateral Training will involve simultaneous use of both upper limbs to perform symmetrical and functional task-based activities designed to improve coordination and motor control of the affected upper limb. Exercises will progress from simple bilateral movements to complex functional tasks such as lifting objects, folding towels, and opening containers. Functional Electrical Stimulation (FES) will be applied to the wrist extensor muscles using the same stimulation parameters as the experimental intervention to ensure consistency. Therapy will be delivered three times per week for eight weeks. | Behavioural | group B bilateral training |
Primary outcome
Change in Wrist Spasticity
Time frame: 8 weeks
Wrist spasticity will be assessed using the Modified Ashworth Scale (MAS), which grades resistance to passive movement from 0 (no increase in muscle tone) to 4 (rigid limb).
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 30 Jan 2026.
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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.
Zikra Azhar, MSPTN principal investigator
The University of Lahore, 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 CIMT and bilateral training in people with Chronic Stroke, run by Zikra Azhar 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 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: looking for participants now, as of the sponsor's last update on 30 Jan 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?
Contact Zikra Azhar, MSPTN (03446928620, zikraazhar4@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Wrist Spasticity (time frame: 8 weeks). 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 30 Jan 2026.