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NCT07919301Not yet recruiting

Virtual Reality Training Dose for Arm Recovery After Stroke: Clinical and Blood Biomarker Responses

Prospective Monitoring of Neuroplastic Effects in Stroke Rehabilitation: Long-term Recovery Prognosis and Therapy Optimization Via Biomarkers

Source: ClinicalTrials.gov · Last updated 5 Nov 2026

Brief summary (registry, in English)

The goal of this clinical trial is to learn whether adding virtual reality (VR) training to conventional rehabilitation improves arm movement in adults who had a stroke 6 to 24 months earlier, and whether VR training 5 days a week gives more benefit than VR training 2 days a week. The study will also measure three blood markers that may reflect brain and muscle adaptation (BDNF, irisin and S100B). The main questions it aims to answer are: * Does arm motor function, measured with the Fugl-Meyer Assessment for Upper Extremity 12 weeks after the start of treatment, improve more when VR training is added to conventional rehabilitation, and does it improve more with 5 than with 2 VR sessions a week? * As an exploratory question, do blood levels of BDNF, irisin and S100B change differently between the groups, and are these changes related to the improvement in arm function? Researchers will compare three groups: conventional rehabilitation alone, conventional rehabilitation plus VR training 2 days a week, and conventional rehabilitation plus VR training 5 days a week. Participants will: * Be assigned by chance to one of the three groups * Receive conventional rehabilitation for 45 minutes, 5 days a week, for 4 weeks; depending on their group, they will also receive 30-minute VR sessions with the Neuroforma system 2 or 5 days a week * Follow a home exercise program from week 4 to week 12 * Have arm function tests and a fasting morning blood sample at the start of the study, at week 4 and at week 12

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
72 (estimated)
First submitted
31 Oct 2026
Start date
1 Dec 2026
Primary completion date
1 Feb 2028
Lead sponsor
Kutahya Health Sciences University
Diseases
Stroke
NCT number
NCT07919301

What you commit to

  • Study type: Interventional
  • Planned participants: 72
  • From 1 Dec 2026 to the primary completion date, 1 Feb 2028
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study design.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Botulinum toxin injection within the previous 3 months
  • Concurrent participation in another experimental rehabilitation program

Other illness

  • Uncontrolled epilepsy
  • History of cybersickness induced by virtual reality

Other

  • Bilateral hemispheric involvement
  • Severe unilateral spatial neglect or global aphasia
  • Active upper-extremity pain (visual analog scale 7/10 or higher) or severe spasticity limiting movement (Modified Ashworth Scale 3 or higher)
  • Severe cardiovascular instability or a contraindication to exercise

Who the study is looking for

  • Age 18 to 75 years
  • Ischemic or hemorrhagic stroke confirmed by computed tomography or magnetic resonance imaging
  • 6 to 24 months since stroke onset
  • Upper-extremity motor impairment, Brunnstrom stage 2 to 4
  • Fugl-Meyer Assessment for Upper Extremity motor score 15 to 50
  • Montreal Cognitive Assessment (MoCA) score of 21 or higher
  • Vision and hearing sufficient to interact with the virtual reality system
  • Able to give written informed consent

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.