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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Post Stroke Balance Behavior Mobility Motor Activity

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Foundation University College of Physical Therapy

Islamabad, 44000, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

m-CIMT with VR exer-games by Kinect Xbox 360

Procedure

Virtual reality workout session will be for about 30 minutes Warm-up exercise will be for 5 minutes including relaxed breathing For week 1-3: Soccer and Space Bubble Pop games will be used For week 4-6: 20,000 Leaks and Rally Ball games will be used 5 minutes will be given for cool down.

m-CIMT with Task-Specific Functional Training

Procedure

Begin with low-intensity exercises and progress to moderate to high intensity; session will be for about 30 minutes Warm-up for 5 minutes;one minute of rest for every five minutes of exercise For week 1-3: Assisted standing and weight shifting, Heel raises, Toe taps, Supported stepping, Unassisted standing and balance tasks will be used For week 4-6: Progressive stepping exercises, Heel-to-toe standing,

Primary outcomes

Motor Control

Time frame: 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

Time frame: 6 weeks

Time Up and Go test: This test will be used to measure mobility in older adults.

Sponsors and collaborators

Lead sponsor

Foundation University Islamabad

Other

Registry information

Important dates

Study start: 2024
Primary completion: 2024
Study completion: 2025
First posted: May 16, 2025
Registry last updated: May 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed