Constraint-Induced Movement Therapy and Bilateral Training in Chronic Stroke

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Pakistan
Shadman Medical Center
RECRUITING
Lahore
Contact Information
Primary
Zikra Azhar, MSPTN
zikraazhar4@gmail.com
03446928620
Backup
Montiha Azeem, MSPTN
muntahaazeem9@gmail.com
03479717317
Time Frame
Start Date: 2026-02-05
Estimated Completion Date: 2026-04-06
Participants
Target number of participants: 112
Treatments
Experimental: group A CIMT
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.
Active_comparator: group B bilateral training
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.
Related Therapeutic Areas
Sponsors
Leads: Zikra Azhar

This content was sourced from clinicaltrials.gov