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StrokeNCT07299162

The Effect of Virtual Reality Therapy on Upper Extremity Functions in Subacute Stroke Patients Receiving Rehabilitation

A study testing Virtual Reality, Conventional rehabilitation and Action observation therapy in people with Stroke and Hemiplegia and/or Hemiparesis Following Stroke, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Virtual Reality, Conventional rehabilitation and Action observation therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Aug 2025to 20 Apr 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Seda Akbayrak, MD contact

+90 5312478829

akbayrakseda@gmail.com

Fatma Nur Kesiktaş, Prof. Dr. contact

+90 5414557933

nur.kesiktas@gmail.com

Turkey (Türkiye)1 site, 1 recruiting
  • Istanbul Physical Therapy and Rehabilitation Training and Research Hospital

    Istanbul, Bahçelievler, 34186

    Seda Akbayrak, MD, +90 5312478829, akbayrakseda@gmail.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the 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.

Being tested
Virtual Reality, Conventional rehabilitation, Action observation therapy
Keywords
Virtual reality, action observation therapy, hemiplegia, hemiparesis, stroke, upper extremity
Medical subject headings
Stroke, Hemiplegia, Paresis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual RealityOther

    Also called exergame

    Camera controlled virtual reality games for upper extremity

  • Conventional rehabilitationOther

    Also called exercise

    Personalized conventional exercises for hemiparesis after stroke

  • Action observation therapyOther

    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.

Study groups in NCT07299162
Study groupRoleWhat they receive
Virtual RealityActive comparatorPatients 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
Receives: Other: Virtual Reality; Other: Conventional rehabilitation; Other: Action observation therapy
ControlOtherPatients 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
Receives: Other: Conventional rehabilitation; Other: Action observation therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From enrollment to the 1 months after treatment

Secondary outcomes (6)
  1. 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.

    Measured: From enrollment to the 1 month after treatment

  2. 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.

    Measured: From enrollment to the 1 month after treatment

  3. 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).

    Measured: From enrollment to the 1 month after treatment

  4. 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.

    Measured: From enrollment to the 1 month after treatment

  5. 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.

    Measured: From enrollment to the 1 month after treatment

  6. 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.

    Measured: From enrollment to the 1 month after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2025
  2. Study start15 Aug 2025
  3. Primary completion25 Mar 2026 (estimated)
  4. Study completion20 Apr 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
38 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07299162
Sponsor's protocol ID
2025-32
Status last verified
Nov 2025
First submitted
25 Nov 2025
Last updated
28 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 25387001

Questions about this trial

What is this clinical trial studying?

A study testing Virtual Reality, Conventional rehabilitation and Action observation therapy in people with Stroke and Hemiplegia and/or Hemiparesis Following Stroke, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Seda Akbayrak, MD (+90 5312478829, akbayrakseda@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fugl-Meyer Upper Extremity (time frame: From enrollment to the 1 months after treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07299162, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.

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Clinical Trial NCT07299162 | AzTrials