Effect of Modified Constraint-induced Movement Therapy Combined With Virtual Reality on Mobility in Post-stroke Patients: A Randomized Control Trial

Not Applicable

Completed

• Conditions: Post Stroke; Mobility; Balance

• Registration Number: NCT06975904
• Lead Sponsor: Foundation University Islamabad

Brief Summary

This study investigates the effectiveness of combining m-CIMT and VR to improve mobility in post-stroke patients. A non-blinded randomized controlled trial will be conducted with 32 participants divided equally into experimental and control groups using purposive sampling. The experimental group will receive m-CIMT with VR training, while the control group will receive m-CIMT with Task-Specific Functional Training. Sessions will be 30 minutes per day, 4 days a week, for 6 weeks. Outcomes will be measured using FMA-LE, BBS, DGI, TUG, and SS-QOL. The study will take place over one year at FFH and FUCP, with ethical approval from ERC FUMC.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-10
• Primary Completion: 2024-12-31
• Study Completion: 2025-03-31
• Status Verified: 2025-05
• Study First Submitted: 2025-05-09
• Study First Submitted QC: 2025-05-09
• Last Update Submitted: 2025-05-09
• Study First Posted: 2025-05-16
• Last Update Posted: 2025-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Sample Selection Criteria

Inclusion Criteria

• Sub-acute and chronic stroke patient >3months
• Males and females of 40-60 years.
• Mini-Mental State Examination score ≥24
• FAC Scale = 3
• Limited spasticity (0,1,1⁺) according to modified Ashworth scale
• Adequate balance and walking ability while wearing the constraint to be eligible to participate in CIMT intervention.

Exclusion Criteria

• Patient with Severe Spasticity and pain
• Patient of Epilepsy, Parkinson's disease and stage 4 arthritis
• Patient with Global Aphasia
• Individuals suffering from unstable angina, symptomatic heart failure, or uncontrolled hypertension
• Patients with any traumatic musculoskeletal injury and surgery of lower limb

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Motor Control	6 weeks	Fugl-Meyer Assessment for Lower Extremity (FMA-LE) is a standardized, stroke-specific tool designed to evaluate motor control. It demonstrates excellent reliability (ICC ≥ 0.98) and strong construct validity.
Mobility	6 weeks	Time Up and Go test: This test will be used to measure mobility in older adults.

Trial Locations

Locations (1)

Foundation University College of Physical Therapy; 🇵🇰 Islamabad, Pakistan