Comparing Two Therapies to Improve Arm Function After Stroke

NCT ID: NCT07093983

Last Updated: 2025-08-03

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-05
• Study Completion Date: 2026-05-01

Brief 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. 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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Constraint-Induced Movement Therapy (CIMT)

Intervention Type: 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 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.

Group Type: EXPERIMENTAL

Coupling Rehabilitation

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Lahore

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maryam Shabbir, PH.D. PT

Role: PRINCIPAL_INVESTIGATOR

University of Lahore

Locations

University of Lahore Teaching Hospital

Lahore, Punjab Province, Pakistan

Countries

Pakistan

Central Contacts

Laraib Akbar, MSPTN

Role: CONTACT

laraibakbar9@gmail.com

+923056926352

Ayesha Jamil, BSPT, TDPT, M PHIL. PT

Role: CONTACT

+923244481031

Facility Contacts

Laraib Akbar, MSPTN

Role: primary

laraibakbar9@gmail.com

+923056926352

Other Identifiers

LARAIB AKBAR

Identifier Type: -

Identifier Source: org_study_id