Virtual Reality-Based Balance Training in Hemiplegic Patients

Evaluation of the Effects of Virtual Reality-Based Balance Games on Walking, Quality of Life, and Balance in Hemiplegic Patients

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Hemiplegia
• Intervention / Treatment: Device: VR-Based Balance Training; Behavioral: Routine Physical Therapy

Detailed Description

The study included 43 hemiplegic patients who met the inclusion criteria and were hospitalized in the neurological rehabilitation unit of the University of Health Sciences Ankara Etlik City Hospital. Patients were randomized into two groups using a sealed-envelope method: 23 patients were assigned to the VR group, which received conventional therapy combined with virtual reality-based balance games, and 20 patients were assigned to the CT group, which received only conventional therapy. The VR group received routine physical therapy and rehabilitation once daily for a total of 20 sessions, in addition to virtual reality-based balance games applied three times a week for 20 minutes per session, totaling 12 sessions, all under the supervision of a physiotherapist. The CT group received only routine physical therapy and rehabilitation once daily for a total of 20 sessions, also under the supervision of a physiotherapist. All patients were evaluated before treatment, at the end of treatment, and eight weeks after the end of treatment using the Berg Balance Test (BBT), Functional Reach Test (FRT), Timed Up and Go Test (TUG), Five Times Sit-to-Stand Test (5xSST), Functional Independence Measure (FIM), Six-Minute Walk Test (6MWT), Stroke-Specific Quality of Life Scale(SS-QOL), and static balance measurements obtained via the Tecnobody PK252 isokinetic balance measurement system.

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • YENIMAHALLE
    • Ankara, YENIMAHALLE, Turkey (Türkiye), 06170
      • Ankara Etlik City Hospital

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VR Group; Participants receive routine physical therapy plus VR-based balance training.	Device: VR-Based Balance Training; 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.
Active Comparator: CT Group; Participants receive routine physical therapy only.	Behavioral: Routine Physical Therapy; Participants receive routine physical therapy and rehabilitation once daily for 20 sessions under physiotherapist supervision, without additional virtual reality-based balance exercises.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Reach Test Distance	Maximum forward reach distance measured while maintaining a fixed base of support, used to assess dynamic balance and postural stability.	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	Time in seconds required for a participant to stand up from a chair, walk 3 meters, turn around, return, and sit down. Shorter times indicate better functional mobility and 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
Five Times Sit-to-Stand Test Time	Time in seconds required for a participant to stand up and sit down five consecutive times from a standard chair, assessing lower limb strength and functional mobility.	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
Functional Independence Measure Total Score (FIM)	Functional independence assessed using the Functional Independence Measure (FIM), consisting of 18 items evaluating self-care, mobility, and cognition. Each item is scored from 1 (total assistance) to 7 (complete independence), with higher total scores indicating greater functional independence.	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
Six-Minute Walk Test Distance (6MWT)	Walking endurance assessed by measuring the total distance a participant can walk on a flat surface in six minutes. Longer distances indicate better aerobic capacity and functional mobility.	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)	The Technobody balance measurement system is typically used to assess static balance and balance limits in an upright position. A lower static balance assessment score indicates less body sway and better motor control and balance function in patients.	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)	The scale consists of 49 items in 12 domains. Each domain has at least 3 items. Each item is evaluated on a 5-point Likert scale, considering the past week. Higher scores indicate better functioning (energy, family roles, language, mobility, mood, personality, self-care, social roles, thinking, upper-extremity function, vision, work/productivity).	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

Collaborators and Investigators

• Sponsor: Gaziantep City Hospital
• Investigators: Study Director: Ece ÜNLÜ AKYÜZ, Medical Doctor, Ankara Etlik City Hospital; Study Director: Aslıhan UZUNKULAOĞLU, Medıcal Doctor, Ankara Etlik City Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2024
• Primary Completion (Actual): April 24, 2025
• Study Completion (Actual): August 4, 2025

Study Registration Dates

• First Submitted: March 8, 2026
• First Submitted That Met QC Criteria: March 11, 2026
• First Posted (Actual): March 16, 2026

Study Record Updates

• Last Update Posted (Actual): March 20, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Virtual Reality; Biofeedback; Hemiplegia; Balance Training
• Additional Relevant MeSH Terms: Neurologic Manifestations; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Paralysis; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Stroke; Hemiplegia
• Other Study ID Numbers: AEŞH-BADEK-2024-059

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data including balance, mobility, functional independence, walking endurance, and quality of life outcomes (BBT, FRT, TUG, 5xSTS, FIM, 6MWT, SS-QOL, and static balance measurements) will be shared.
• IPD Sharing Time Frame: Data will be available after publication of the study results.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

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