Constraint Induced Movement Therapy and Bilateral Training in Chronic Stroke

NCT07378774 | Recruiting DMC

• 1 other identifier: UOL/IREB/25/15/03/40
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Chronic Stroke

Keywords

Chronic stroke; Constraint-induced movement therapy; Bilateral training; Upper limb rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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).

  8 weeks

Study Arms (2)

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.

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.

Behavioral: bilateral training

Interventions

bilateral training BEHAVIORAL

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.

group B bilateral training

CIMT BEHAVIORAL

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.

Also known as: Constrain induced movement therapy

group A CIMT

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• Acute and other neurological and musculoskeletal conditions e.g. Parkinson's, multiple sclerosis. Patients who do not agree to treatment.

Sponsors & Collaborators

• Zikra Azhar: lead

Study Sites (1)

Shadman Medical Center

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Study Officials

• Zikra Azhar, MSPTN

  The University of Lahore, Lahore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zikra Azhar, MSPTN

CONTACT

03446928620; zikraazhar4@gmail.com

Montiha Azeem, MSPTN

CONTACT

03479717317; muntahaazeem9@gmail.com

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 INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: January 22, 2026
• First Posted: January 30, 2026
• Study Start: February 5, 2026
• Primary Completion: April 5, 2026
• Study Completion: April 6, 2026
• Last Updated: January 30, 2026

Record last verified: 2026-01

Locations

PA (1)