The Effect of Virtual Reality Therapy on Upper Extremity Functions in Subacute Stroke Patients Receiving Rehabilitation
NCT ID: NCT07299162
Last Updated: 2025-12-23
Study Results
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Basic Information
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RECRUITING
NA
38 participants
INTERVENTIONAL
2025-08-15
2026-04-20
Brief Summary
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In our study, patients will be randomly divided into two groups: one group will receive conventional rehabilitation and Action Observation Therapy, while the other group will additionally receive Virtual Reality therapy. This study aims to investigate the contribution of Virtual Reality therapy, when added to conventional rehabilitation and Action Observation Therapy, to the recovery of the paretic upper extremity in patients with subacute stroke.
Detailed Description
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All volunteer patients will be evaluated at the beginning of the treatment using the following assessment tools: Fugl-Meyer Assessment-Upper Extremity, Brunnstrom Stages-Upper Extremity/Hand, Wolf Motor Function Test, Motricity Index-Arm, Stroke Impact Scale 3.0, and Task-Based Exercises (number of times the patient can bring their hand to the mouth, behind the head, and to the sacrum in one minute).
Patients will be randomly assigned to two groups using computerized randomization.
One group will receive conventional therapy 5 days per week plus Action Observation Therapy (AOT) 3 times per week for 30 minutes.
Each AOT session will consist of videos featuring goal-oriented tasks prepared according to the individual needs of the patient. The videos will change weekly. The first session each week will be supervised by the physician, while the other two sessions will be performed independently by the patient.
In AOT, each task is broken down into subcomponents. Each sub-task will be observed for 3 minutes, followed by a 2-minute practice period. For example, the task of drinking water from a glass will be divided into three sub-actions: (1) fill the glass, (2) hold the glass, and (3) bring the glass to the mouth. Each sub-action will be presented as a video for 3 minutes, followed by 2 minutes of attempted execution by the patient.
The second group will receive conventional therapy 5 days per week, plus Action Observation Therapy (as described above) and Virtual Reality therapy (exergaming) using Becure SmartPose games, 3 times per week for 30 minutes.
After completing the 5-week treatment program, a follow-up assessment will be performed at the end of treatment and one month after treatment completion.
Sample Size Calculation
The primary outcome measure is the Fugl-Meyer Assessment-Upper Extremity. Measurements will be taken at baseline, post-treatment, and one month after treatment for both the virtual reality group and the control group.
Using a medium effect size (partial eta-squared = 0.06) for repeated measures mixed model ANOVA, with α = 0.05 and power = 0.85, the minimum required sample size was calculated as 16 participants per group, 32 in total. Considering an estimated 15% dropout rate, the final sample size was adjusted to 38 participants. The calculation was performed using G\*Power version 3.1.9.4 (Franz Faul, Universität Kiel, Germany).
Statistical Analysis
The normality of the data distribution will be tested using the Shapiro-Wilk test.
If data are normally distributed, repeated measures ANOVA will be used to compare all variables (Fugl-Meyer Upper Extremity, Brunnstrom Upper Extremity/Hand, Wolf Motor Function Test, Motricity Index-Arm, Stroke Impact Scale 3.0, and Task-Based Exercises).
If the overall ANOVA reveals significance (p \< 0.05), Post Hoc pairwise comparisons will be conducted to determine which time points differ.
If data are not normally distributed, within-group comparisons will be conducted using the Friedman test and Wilcoxon signed-rank test, while between-group comparisons will be performed using the Mann-Whitney U test.
Bonferroni-corrected p-values \< 0.05 will be considered statistically significant in post hoc comparisons.
All analyses will be conducted using SPSS version 18.0.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Virtual Reality
Patients in this group will receive virtual reality rehabilitation for 5 weeks, 3 times a week for a total of 15 sessions. Additionally they will receive conventional rehabilitation six days a week for 5 weeks and action observation therapy for 3 times a week for 5 weeks. For action observation therapy 1 session each week will be done under supervision of principal investigator and 2 sessions will performed independently by the patient
Virtual Reality
Camera controlled virtual reality games for upper extremity
Conventional rehabilitation
Personalized conventional exercises for hemiparesis after stroke
Action observation therapy
Rehabilitation method that involves patients watching video recordings of purposeful upper extremity movements designed for daily life activities followed by physically attempting the same movements.
Control
Patients in this group will receive conventional rehabilitation six days a week for 5 weeks and action observation therapy for 3 times a week for 5 weeks. For action observation therapy 1 session each week will be done under supervision of principal investigator and 2 sessions will performed independently by the patient
Conventional rehabilitation
Personalized conventional exercises for hemiparesis after stroke
Action observation therapy
Rehabilitation method that involves patients watching video recordings of purposeful upper extremity movements designed for daily life activities followed by physically attempting the same movements.
Interventions
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Virtual Reality
Camera controlled virtual reality games for upper extremity
Conventional rehabilitation
Personalized conventional exercises for hemiparesis after stroke
Action observation therapy
Rehabilitation method that involves patients watching video recordings of purposeful upper extremity movements designed for daily life activities followed by physically attempting the same movements.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients in the subacute phase of stroke (between 6 weeks and 6 months post-stroke)
* Patients with a first-ever stroke
* Brunnstrom stage 3 or above for both upper extremity and hand
* Mini-Mental State Examination (MMSE) score \>=20
No major medical condition that would prevent participation in the treatment
Exclusion Criteria
* History of bilateral stroke
* Patients with global aphasia and/or cognitive impairment that significantly affects treatment compliance
* Patients with severe visual impairment
* Presence of unilateral spatial neglect
* Inability to maintain sitting balance
* Modified Ashworth Scale \> 4 in the hemiplegic arm
18 Years
ALL
No
Sponsors
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Inosens information technologies limited company
UNKNOWN
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
OTHER_GOV
Responsible Party
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Seda Akbayrak
Resident Doctor
Principal Investigators
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Seda Akbayrak, MD
Role: PRINCIPAL_INVESTIGATOR
Istanbul Physical Therapy and Rehabilitation Training and Research Hospital
Locations
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Istanbul Physical Therapy and Rehabilitation Training and Research Hospital
Istanbul, Bahçelievler, Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Seda Akbayrak, MD
Role: primary
References
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Yu JA, Park J. The effect of first-person perspective action observation training on upper extremity function and activity of daily living of chronic stroke patients. Brain Behav. 2022 May;12(5):e2565. doi: 10.1002/brb3.2565. Epub 2022 Apr 10.
Pollock A, Farmer SE, Brady MC, Langhorne P, Mead GE, Mehrholz J, van Wijck F. Interventions for improving upper limb function after stroke. Cochrane Database Syst Rev. 2014 Nov 12;2014(11):CD010820. doi: 10.1002/14651858.CD010820.pub2.
Ikbali Afsar S, Mirzayev I, Umit Yemisci O, Cosar Saracgil SN. Virtual Reality in Upper Extremity Rehabilitation of Stroke Patients: A Randomized Controlled Trial. J Stroke Cerebrovasc Dis. 2018 Dec;27(12):3473-3478. doi: 10.1016/j.jstrokecerebrovasdis.2018.08.007. Epub 2018 Sep 5.
Chen J, Or CK, Chen T. Effectiveness of Using Virtual Reality-Supported Exercise Therapy for Upper Extremity Motor Rehabilitation in Patients With Stroke: Systematic Review and Meta-analysis of Randomized Controlled Trials. J Med Internet Res. 2022 Jun 20;24(6):e24111. doi: 10.2196/24111.
Other Identifiers
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2025-32
Identifier Type: -
Identifier Source: org_study_id