Virtual Reality-Based Balance Training in Hemiplegic Patients (NCT07475598) | Clinical Trial Compass
CompletedNot Applicable
Virtual Reality-Based Balance Training in Hemiplegic Patients
Turkey (Türkiye)43 participantsStarted 2024-01-24
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Berg Balance Scale Score
Timeframe: 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