Comparing Two Therapies to Improve Arm Function After Stroke

NCT07093983 | Not Yet Recruiting DMC

• 1 other identifier: LARAIB AKBAR
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Stroke

Keywords

CouplingRehabilitation; CIMT; Stroke; impairment

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Baseline, 6 weeks, and 12 weeks after start of intervention

Study Arms (2)

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.

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.

Other: Coupling Rehabilitation

Interventions

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.

Constraint-Induced Movement Therapy (CIMT) Group

Coupling Rehabilitation 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.

Coupling Rehabilitation Group

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Lahore: lead

Study Sites (1)

University of Lahore Teaching Hospital

Lahore, Punjab Province, 54600, Pakistan

Location

MeSH Terms

Conditions

Stroke

Interventions

Constraint Induced Movement Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Physical Therapy Modalities; Therapeutics; Rehabilitation

Study Officials

• Maryam Shabbir, PH.D. PT

  University of Lahore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laraib Akbar, MSPTN

CONTACT

+923056926352; laraibakbar9@gmail.com

Ayesha Jamil, BSPT, TDPT, M PHIL. PT

CONTACT

+923244481031

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2025
• First Posted: July 30, 2025
• Study Start: August 5, 2025
• Primary Completion: April 1, 2026
• Study Completion: May 1, 2026
• Last Updated: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

PA (1)