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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VR Group | Experimental | Participants receive routine physical therapy plus VR-based balance training. |
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| CT Group | Active Comparator | Participants receive routine physical therapy only. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ece ÜNLÜ AKYÜZ, Medical Doctor | Ankara Etlik City Hospital | Study Director |
| Aslıhan UZUNKULAOĞLU, Medıcal Doctor | Ankara Etlik City Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara Etlik City Hospital | Ankara | YENIMAHALLE | 06170 | Turkey (Türkiye) |
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.
Data will be available after publication of the study results.
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.
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D006429 | Hemiplegia |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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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.
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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.
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| 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. |
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| 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 |
| 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 |
| 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 |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010243 | Paralysis |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |