Constraint Induced Movement Therapy and Bilateral Training in Chronic Stroke

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorZikra Azhar

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

112 Participants
are divided into 2 treatment groups
Group A: group A CIMTExperimental treatment 1 intervention
Group B: group B bilateral trainingActive comparator 1 intervention

Trial outcomes

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).

Time frame
8 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

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Zikra Azhar

Lead sponsor

University of Lahore

Sponsor institution