The Effect of Virtual Reality Therapy on Upper Extremity Functions in Subacute Stroke Patients Receiving Rehabilitation
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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Virtual Reality, Conventional rehabilitation, Action observation therapy.
- Who it may be relevant to
- Registry conditions: Stroke, Hemiplegia and/or Hemiparesis Following Stroke. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Effect of Virtual Reality Therapy on Upper Extremity Functions in Subacute Stroke Patients Receiving Conventional Rehabilitation and Action Observation Therapy: A Randomized Controlled Single-Blind Study
Overview
Stroke ranks second among the leading causes of death worldwide and third among the causes of disability. In stroke patients, motor impairment typically affects facial movements and the upper and lower extremities unilaterally. Upper extremity involvement, in particular, negatively impacts patients' activities of daily living, such as eating and dressing. Various rehabilitation methods are used to improve the function of the paretic upper extremity in stroke patients. Action Observation Therapy and Virtual Reality are among the rehabilitation approaches currently used to support upper extremity rehabilitation. 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
Methodology
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.
Interventions
- Other Virtual Reality
Camera controlled virtual reality games for upper extremity - Other Conventional rehabilitation
Personalized conventional exercises for hemiparesis after stroke - Other 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.
Primary outcome measures
- Fugl-Meyer Upper Extremity [Time frame: From enrollment to the 1 months after treatment]
Secondary outcome measures (6)
- WOLF motor function test - Functional Ability Scale [Time frame: From enrollment to the 1 month after treatment]
- Motricity Index - Upper Extremity [Time frame: From enrollment to the 1 month after treatment]
- Stroke Impact Scale 3.0: [Time frame: From enrollment to the 1 month after treatment]
- Brunnstrom Upper Extremity and Hand [Time frame: From enrollment to the 1 month after treatment]
- Task Specific Exercises [Time frame: From enrollment to the 1 month after treatment]
- The Wolf Motor Function Test (WMFT)- Performance Time [Time frame: From enrollment to the 1 month after treatment]
Eligibility criteria
Inclusion criteria
- Patients over the age of 18
- 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
- Presence of pain in the paretic shoulder severe enough to prevent exercise
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Turkey (Türkiye) · 1 center
- Istanbul Physical Therapy and Rehabilitation Training and Research Hospital — Istanbul
Publications
- 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. PMID 30193810
- 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. PMID 35723907
- 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. PMID 35398981
- 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. PMID 25387001
Identifiers
NCT: NCT07299162 · 2025-32