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

NCT06975904 | Completed

• 1 other identifier: FUI/CTR/2024/72
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Keywords

Stroke rehabilitation; Hemiplegia therapy; Motor activity; Gait physiology; Neuroplasticity; Movement disorders rehabilitation; Constraint-Induced Movement Therapy; Virtual reality therapy; Lower extremity pathophysiology

Outcome Measures

Primary Outcomes (2)

• Motor Control

  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.

  6 weeks

• Mobility

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

  6 weeks

Study Arms (2)

m-CIMT with Task-Specific Functional Training

ACTIVE COMPARATOR

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

Procedure: m-CIMT with Task-Specific Functional Training

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

EXPERIMENTAL

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.

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

Interventions

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 VR exer-games by Kinect Xbox 360

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,

m-CIMT with Task-Specific Functional Training

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Foundation University Islamabad: lead

Study Sites (1)

Foundation University College of Physical Therapy

Islamabad, 44000, Pakistan

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2025
• First Posted: May 16, 2025
• Study Start: July 10, 2024
• Primary Completion: December 31, 2024
• Study Completion: March 31, 2025
• Last Updated: May 16, 2025

Record last verified: 2025-05

Locations

PA (1)