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

NCT06739902 | Active Not Recruiting DMC

• 1 other identifier: MSRSW/Batch-Fall22/770
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Interventional group I

EXPERIMENTAL

Diagnostic Test: Traditional Physiotherapy Group

Interventional group II

ACTIVE COMPARATOR

Combination Product: VR + Traditional Physiotherapy Group

Interventions

Traditional Physiotherapy Group DIAGNOSTIC_TEST

Participants receive standard physiotherapy exercises aimed at improving motor function, balance, and trunk stability. These exercises include stretching, balance training, and muscle-strengthening activities.

Interventional group I

VR + Traditional Physiotherapy Group COMBINATION_PRODUCT

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.

Interventional group II

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Superior University: lead

Study Sites (1)

Services Hospital, Shadman 1

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 13, 2024
• First Posted: December 18, 2024
• Study Start: February 28, 2024
• Primary Completion: August 1, 2024
• Study Completion: March 1, 2025
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)