Comparing Two Therapies to Improve Arm Function After Stroke (CR vs CIMT)

July 30, 2025 updated by: University of Lahore

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Ayesha Jamil, BSPT, TDPT, M PHIL. PT
  • Phone Number: +923244481031

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54600
        • University of Lahore Teaching Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria: •Age 40-65 years old

  • 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

-

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Constraint-Induced Movement Therapy (CIMT) Group
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.
Other: 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.
Experimental: Coupling Rehabilitation Group
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.
Other: Coupling Rehabilitation
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 6 weeks, and 12 weeks after start of intervention
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.
Baseline, 6 weeks, and 12 weeks after start of intervention
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.
Baseline, 6 weeks, and 12 weeks after start of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Lahore

Investigators

  • Principal Investigator: Maryam Shabbir, PH.D. PT, The University of Lahore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 5, 2025

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

July 22, 2025

First Submitted That Met QC Criteria

July 22, 2025

First Posted (Actual)

July 30, 2025

Study Record Updates

Last Update Posted (Actual)

August 3, 2025

Last Update Submitted That Met QC Criteria

July 30, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LARAIB AKBAR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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