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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06975904
Enrollment
32
Registered
2025-05-16
Start date
2024-07-10
Completion date
2025-03-31
Last updated
2025-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Balance, Mobility, Post Stroke

Keywords

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

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.

Interventions

PROCEDUREm-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.

PROCEDUREm-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,

Sponsors

Foundation University Islamabad
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
40 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Motor Control6 weeksFugl-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.
Mobility6 weeksTime Up and Go test: This test will be used to measure mobility in older adults.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026