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

NCT ID: NCT06975904

Last Updated: 2025-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-10
• Study Completion Date: 2025-03-31

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.

Conditions

Post Stroke; Mobility; Balance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

m-CIMT with Task-Specific Functional Training

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, Unassisted balance and coordination tasks, Advanced stepping patterns and dynamic balance challenges, Functional tasks like step-ups and lateral steps will be used 5 minutes will be given for cool down

Group Type: ACTIVE_COMPARATOR

m-CIMT with Task-Specific Functional Training

Intervention Type: 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,

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

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Interventions

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

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.

Intervention Type: PROCEDURE

m-CIMT with Task-Specific Functional Training

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,

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Sample Selection 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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Foundation University Islamabad

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Foundation University College of Physical Therapy

Islamabad, , Pakistan

Countries

Pakistan

Other Identifiers

FUI/CTR/2024/72

Identifier Type: -

Identifier Source: org_study_id