An interventional study of Virtual Reality and Conventional rehabilitation in Stroke and Hemiplegia and/or Hemiparesis Following Stroke, sponsored by Istanbul Physical Medicine Rehabilitation Training and Research Hospital. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-28.
Sponsored by Istanbul Physical Medicine Rehabilitation Training and Research Hospital · Not applicable, Interventional, and Treatment
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.
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.
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's planned enrollment of 38 is below the median of 49 across 6,024 interventional studies indexed under Stroke.
Browse Stroke studies →Istanbul Physical Medicine Rehabilitation Training and Research Hospital is the lead sponsor of 123 studies on the registry; 26 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
No major medical condition that would prevent participation in the treatment
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Other: Virtual Reality · Other: Conventional rehabilitation · Other: Action observation therapy
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
Other: Conventional rehabilitation · Other: Action observation therapy
Camera controlled virtual reality games for upper extremity
Also known as: exergame
Personalized conventional exercises for hemiparesis after stroke
Also known as: exercise
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.
Fugl-Meyer Upper Extremity
The Fugl-Meyer Assessment for Upper Extremity (FMA-UE) is a standardized scale used to assess motor recovery of the upper limb in post-stroke patients. It evaluates voluntary movement, reflex activity, coordination, and speed. The scale consists of 33 items, and the total score ranges from 0 to 66, with 0 indicating no motor function and 66 representing normal motor function. A Turkish validity and reliability study has also been conducted for this scale.
Time frame: From enrollment to the 1 months after treatment
WOLF motor function test - Functional Ability Scale
The Wolf Motor Function Test (WMFT) is an assessment tool developed to evaluate motor skills in patients with upper extremity motor deficits. The test consists of 17 items. For 15 items, data is collected on functional ability and performance time, while 2 items assess muscle strength. 2 tests for muscle strength were not used.Each activity is scored on a Functional Ability Scale ranging from 0 to 5, where 0 indicates no use of the affected limb during the activity, and 5 represents normal movement. An average score is calculated for the Functional Ability Scale, with higher scores indicating better motor function. A Turkish version of the WMFT has also been validated and found reliable for use in stroke patients.
Time frame: From enrollment to the 1 month after treatment
Motricity Index - Upper Extremity
The Motricity Index is a scale used to determine patients' motor function levels. In our study, the Motricity Index - Upper Extremity score will be calculated to evaluate upper limb function following stroke. The minimum score is 0 and the maximum score is 99. A Turkish version of the motricity index has been validated and found reliable for use.
Time frame: From enrollment to the 1 month after treatment
Stroke Impact Scale 3.0:
The Stroke Impact Scale is a stroke-specific health status measure designed to assess the quality of life and functional independence of patients after stroke. It allows both patients and their caregivers to evaluate the patient's overall condition. The assessment uses a 5-point Likert scale for scoring. Scores for each domain range from 0 to 100. In addition to questions across 8 subdomains, SIS 3.0 includes a visual analog scale to measure perceived recovery after stroke, scored from 0 to 100 (0 = no recovery, 100 = full recovery).
Time frame: From enrollment to the 1 month after treatment
Brunnstrom Upper Extremity and Hand
The Brunnstrom method evaluates motor recovery in stroke patients through six sequential stages. Stage 1 represents the worst condition, characterized by flaccidity and no voluntary movement in the upper extremity. Stage 6 indicates the best outcome, where coordinated, voluntary, and normal movement patterns are fully restored. This scale helps clinicians determine the patient's current recovery stage and plan appropriate rehabilitation strategies.
Time frame: From enrollment to the 1 month after treatment
Task Specific Exercises
Task-specific exercises include counting how many times the patient can bring their hand to their mouth, behind their head, and to their sacrum within one minute. A higher number of repetitions within the one-minute interval indicates better upper extremity motor function.
Time frame: From enrollment to the 1 month after treatment
The Wolf Motor Function Test (WMFT)- Performance Time
The Wolf Motor Function Test (WMFT) is an assessment tool developed to evaluate motor skills in patients with upper extremity motor deficits. The test consists of 17 items. For 15 items, data is collected on functional ability and performance time, while 2 items assess muscle strength. 2 tests for muscle strength were not used. Performance Time is recorded in seconds. The maximum allowed time to complete an activity is 120 seconds. If the patient is unable to complete the activity within this time, a score of 120 seconds is assigned. Therefore, the median score is calculated for Performance Time. A Turkish version of the WMFT has also been validated and found reliable for use in stroke patients.
Time frame: From enrollment to the 1 month after treatment
Plan to share: Undecided
Started Aug 2025 (actual). Primary completion is estimated for Mar 2026, 7 months after the start.
Of 3,108 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's planned 7 months is below that.
Counting every sponsor, half of 3,252 studies reached it within 23 months; a quarter within 10 and three quarters within 46.
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