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Completed

NCT Number: NCT07475598

Virtual Reality-Based Balance Training 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.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Etlik City Hospital

Ankara, YENIMAHALLE, 06170, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

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.

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.

Primary outcomes

  1. Berg Balance Scale Score

    Time frame: 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

    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.

Secondary outcomes

  1. Functional Reach Test Distance

    Time frame: 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

    Maximum forward reach distance measured while maintaining a fixed base of support, used to assess dynamic balance and postural stability.

  2. Timed Up and Go Test Time

    Time frame: 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

    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.

  3. Five Times Sit-to-Stand Test Time

    Time frame: 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

    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.

  4. Static Balance Score (Tecnobody PK252 Isokinetic Balance Measurement System)

    Time frame: 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

    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.

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

    Time frame: 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

    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).

  6. Functional Independence Measure Total Score (FIM)

    Time frame: 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 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.

  7. Six-Minute Walk Test Distance (6MWT)

    Time frame: 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

    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.

Sponsors and collaborators

Lead sponsor

Gaziantep City Hospital

Other

Registry information

Official study title

Effects of Virtual Reality-Based Balance Games on Gait, Balance, and Quality of Life in Patients With Post-Stroke Hemiplegia: A Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 16, 2026
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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