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

Foundation University Islamabad

Status: Completed

Conditions: Balance; Mobility; Post Stroke

Treatments: Procedure: m-CIMT with VR exer-games by Kinect Xbox 360; Procedure: m-CIMT with Task-Specific Functional Training

Study type: Interventional

Funder types: Other

Identifiers

NCT06975904

FUI/CTR/2024/72

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 40 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

m-CIMT with Task-Specific Functional Training

Active Comparator group

Description:

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

Treatment:

Procedure: m-CIMT with Task-Specific Functional Training

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

Experimental group

Description:

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.

Treatment:

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