Comparing the Effectiveness of Traditional Physiotherapy Combined With Virtual Reality for Post-Stroke Patients

This study aims to evaluate the effectiveness of combining virtual reality (VR) therapy with traditional physiotherapy in post-stroke rehabilitation. Post-stroke patients often suffer from impairments in motor function, balance, and overall quality of life. While traditional physiotherapy is a widely accepted method for stroke recovery, incorporating VR technology may enhance treatment outcomes by providing an engaging, immersive environment that motivates patients to perform therapeutic movements.

Study Overview

• Status: Active, not recruiting
• Conditions: Stroke
• Intervention / Treatment: Diagnostic test: Traditional Physiotherapy Group; Combination product: VR + Traditional Physiotherapy Group

Detailed Description

This study will compare the functional and quality-of-life improvements in patients undergoing traditional physiotherapy alone versus those receiving a combination of conventional physiotherapy and VR interventions. By assessing changes in motor function, trunk stability, balance, and quality of life, this research will provide valuable insights into whether VR can be an effective adjunctive tool in post-stroke rehabilitation programs.

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan
      • Services Hospital, Shadman 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Stroke, either ischemic or hemorrhagic
• Participants who can ambulate independently or with minimal assistance.
• Participants who were willing & able to adhere to the study protocol.
• Including participants who were attending follow-up appointments & completing outcome measures.
• Participants who were able to understand & provide written informed consent

Exclusion Criteria:

• Existence of additional neurological disorders (such as multiple sclerosis or Parkinson's disease) or serious medical conditions that could prevent participants from participating in the study.
• Participants receiving rehabilitation or rigorous physical treatment in the previous three months were excluded.
• Pregnant women or breastfeeding women.
• Participants who refused to participate in the study or provide informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional group I	Diagnostic test: Traditional Physiotherapy Group; Participants receive standard physiotherapy exercises aimed at improving motor function, balance, and trunk stability. These exercises include stretching, balance training, and muscle-strengthening activities.
Active Comparator: Interventional group II	Combination product: VR + Traditional Physiotherapy Group; Participants receive the same physiotherapy exercises as the traditional group, but with additional sessions involving virtual reality exercises. The VR component includes immersive activities that stimulate motor control, coordination, and cognitive engagement to support functional recovery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Berg Balance Scale (BBS)	Assesses balance and stability.- *Purpose*: Assesses balance in older adults and individuals with balance disorders.; *Items*: 14 tasks, such as sitting, standing, reaching, and turning.; *Scoring*: Each task is scored on a scale of 0-4 (0 = inability to perform the task, 4 = normal performance).; *Total Score*: The maximum score is 56. Higher scores indicate better balance. A score below 45 indicates a higher risk of falling.	12 Months
Trunk Impairment Scale (TIS)	Measures trunk control and stability. SF-12 Health Survey: Evaluates quality of life in physical and mental health domains.The *Trunk Impairment Scale (TIS)* is a clinical tool used to assess trunk performance in individuals, particularly those with neurological impairments like stroke. It measures three key aspects: *static sitting balance, **dynamic sitting balance, and **coordination of trunk movements. The scale consists of **17 items*, with scores ranging from 0 to 23. Higher scores indicate better trunk control and stability. It helps clinicians evaluate and track improvements in trunk function over time, guiding rehabilitation interventions.	12 Months

Collaborators and Investigators

• Sponsor: Superior University

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2024
• Primary Completion (Actual): August 1, 2024
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: December 13, 2024
• First Submitted That Met QC Criteria: December 13, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 13, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: MSRSW/Batch-Fall22/770

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No