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

NCT07299162 | Recruiting

• 1 other identifier: 2025-32
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Stroke; Hemiplegia and/or Hemiparesis Following Stroke

Keywords

Virtual reality; action observation therapy; hemiplegia; hemiparesis; stroke; upper extremity

Outcome Measures

Primary Outcomes (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.

  From enrollment to the 1 months after treatment

Secondary Outcomes (6)

• WOLF motor function test - Functional Ability Scale

  From enrollment to the 1 month after treatment

• Motricity Index - Upper Extremity

  From enrollment to the 1 month after treatment

• Stroke Impact Scale 3.0:

  From enrollment to the 1 month after treatment

• Brunnstrom Upper Extremity and Hand

  From enrollment to the 1 month after treatment

• Task Specific Exercises

  From enrollment to the 1 month after treatment

Study Arms (2)

Virtual Reality

ACTIVE COMPARATOR

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

Control

OTHER

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

Interventions

Virtual Reality OTHER

Camera controlled virtual reality games for upper extremity

Also known as: exergame

Virtual Reality

Conventional rehabilitation OTHER

Personalized conventional exercises for hemiparesis after stroke

Also known as: exercise

Control; Virtual Reality

Action observation therapy OTHER

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; Virtual Reality

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Physical Medicine Rehabilitation Training and Research Hospital: lead
• Inosens information technologies limited company: collaborator

Study Sites (1)

Istanbul Physical Therapy and Rehabilitation Training and Research Hospital

Istanbul, Bahçelievler, 34186, Turkey (Türkiye)

RECRUITING

Related Publications (4)

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

MeSH Terms

Conditions

Stroke; Hemiplegia; Paresis

Interventions

Exergaming; Exercise

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Seda Akbayrak, MD

  Istanbul Physical Therapy and Rehabilitation Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Seda Akbayrak, MD

CONTACT

+90 5312478829; akbayrakseda@gmail.com

Fatma Nur Kesiktaş, Prof. Dr.

CONTACT

+90 5414557933; nur.kesiktas@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Doctor

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 23, 2025
• Study Start: August 15, 2025
• Primary Completion: March 25, 2026
• Study Completion: April 20, 2026
• Last Updated: January 28, 2026

Record last verified: 2025-11

Locations

TU (1)