Virtual Reality-Based Balance Training in Hemiplegic Patients

NCT07475598 | Completed

• 1 other identifier: AEŞH-BADEK-2024-059
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective single-blind randomized controlled trial enrolled 43 hemiplegic patients hospitalized in the neurological rehabilitation unit of the University of Health Sciences Ankara Etlik City Hospital. Participants were randomly assigned to a virtual reality (VR) group (n = 23), which received routine physical therapy combined with VR-based balance training, or a conventional therapy (CT) group (n = 20), which received routine physical therapy alone. Interventions were delivered under physiotherapist supervision over 20 sessions, with the VR group receiving an additional 12 sessions of VR-based balance exercises. Outcomes were assessed at baseline, immediately post-treatment, and at an eight-week follow-up, including measures of balance, mobility, functional independence, walking capacity, quality of life, and static balance using the Tecnobody PK252 isokinetic balance measurement system.

Conditions

Stroke; Hemiplegia

Keywords

Virtual Reality; Balance Training; Biofeedback; Hemiplegia

Outcome Measures

Primary Outcomes (1)

• Berg Balance Scale Score

  Balance performance assessed using the Berg Balance Scale, which includes 14 functional tasks scored from 0 to 4 with a total score ranging from 0 to 56. Higher scores indicate better balance.

  Baseline (pre-treatment): Before the first therapy session End of Treatment: After completion of 20 conventional therapy sessions and 12 VR sessions (approximately 4 weeks from baseline) Follow-up: 8 weeks after the end of treatment

Secondary Outcomes (7)

• Functional Reach Test Distance

  Baseline (pre-treatment): Before the first therapy session End of Treatment: After completion of 20 conventional therapy sessions and 12 VR sessions (approximately 4 weeks from baseline) Follow-up: 8 weeks after the end of treatment

• Timed Up and Go Test Time

  Baseline (pre-treatment): Before the first therapy session End of Treatment: After completion of 20 conventional therapy sessions and 12 VR sessions (approximately 4 weeks from baseline) Follow-up: 8 weeks after the end of treatment

• Five Times Sit-to-Stand Test Time

  Baseline (pre-treatment): Before the first therapy session End of Treatment: After completion of 20 conventional therapy sessions and 12 VR sessions (approximately 4 weeks from baseline) Follow-up: 8 weeks after the end of treatment

• Static Balance Score (Tecnobody PK252 Isokinetic Balance Measurement System)

  Baseline (pre-treatment): Before the first therapy session End of Treatment: After completion of 20 conventional therapy sessions and 12 VR sessions (approximately 4 weeks from baseline) Follow-up: 8 weeks after the end of treatment

• Stroke-Specific Quality of Life Scale Score (SS-QOL)

  Baseline (pre-treatment): Before the first therapy session End of Treatment: After completion of 20 conventional therapy sessions and 12 VR sessions (approximately 4 weeks from baseline) Follow-up: 8 weeks after the end of treatment

Study Arms (2)

VR Group

EXPERIMENTAL

Participants receive routine physical therapy plus VR-based balance training.

Device: VR-Based Balance Training

CT Group

ACTIVE COMPARATOR

Participants receive routine physical therapy only.

Behavioral: Routine Physical Therapy

Interventions

VR-Based Balance Training DEVICE

Participants receive routine physical therapy and rehabilitation once daily for 20 sessions, plus virtual reality-based balance exercises three times per week for 20 minutes per session (total 12 sessions), all under physiotherapist supervision.

VR Group

Routine Physical Therapy BEHAVIORAL

Participants receive routine physical therapy and rehabilitation once daily for 20 sessions under physiotherapist supervision, without additional virtual reality-based balance exercises.

CT Group

Eligibility Criteria

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

You may qualify if:

• Ages 18-75
• Hemiplegic patients (ischemic/hemorrhagic) for 3-18 months
• No severe cognitive impairment, able to respond to visual and auditory commands
• Mini Mental Test (MMT) score of 24 or higher
• Ability to sit or stand independently
• Berg Balance Test (BBT) score of at least 21-56 points (patient group with moderate and/or low risk of falls)
• Brunnstrom 1-2-3 (for paretic upper extremity)
• No history of non-paretic upper extremity fracture or amputation
• No condition that prevents exercise
• Individuals weighing less than 110 kg
• Each patient must be successful in at least 1 round in each game

You may not qualify if:

• Refusal to participate in the study or wishing to withdraw from the study
• Having communication problems such as speech and language problems
• Having advanced visual, vestibular or metabolic disorders that cause balance disorders
• Having other neurological diseases that cause gait disorders (Parkinson's, Multiple Sclerosis, Neuromuscular Diseases, Myelomalacia, etc.)

Sponsors & Collaborators

• Gaziantep City Hospital: lead

Study Sites (1)

Ankara Etlik City Hospital

Ankara, YENIMAHALLE, 06170, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stroke; Hemiplegia

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ece ÜNLÜ AKYÜZ, Medical Doctor

  Ankara Etlik City Hospital

  STUDY DIRECTOR

• Aslıhan UZUNKULAOĞLU, Medıcal Doctor

  Ankara Etlik City Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This study was a prospective, single-blind, randomized controlled trial. Patients were randomized into two groups. The physiotherapists delivering the interventions were blinded to group assignments to prevent performance bias. Participants were aware of their intervention, but outcome assessments were conducted in a blinded manner to minimize detection bias.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant

Model Details: Patients were randomly assigned to two parallel groups: a VR group (n = 23) receiving routine physical therapy plus virtual reality-based balance training, and a CT group (n = 20) receiving routine physical therapy only. Interventions were delivered under physiotherapist supervision over 20 sessions, with the VR group receiving an additional 12 VR-based balance sessions. Outcomes, including balance, mobility, functional independence, walking capacity, quality of life, and static balance, were assessed at baseline, post-treatment, and eight-week follow-up using standardized clinical tests and the Tecnobody PK252 system.

Study Record Dates

• First Submitted: March 8, 2026
• First Posted: March 16, 2026
• Study Start: January 24, 2024
• Primary Completion: April 24, 2025
• Study Completion: August 4, 2025
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available after publication of the study results.
• Access Criteria: De-identified individual participant data and supporting documents will be available to qualified researchers upon reasonable request to the principal investigator. Access will be granted for scientific research purposes after approval of the research proposal. Data will be shared through secure electronic transfer.

Locations

TU (1)