Virtual Reality Mirrors Therapy Usability

NCT07039136 | Recruiting

• 1 other identifier: AIBU-FTR-RK-11
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 2

Brief Summary

Mirror therapy has been shown to support motor recovery by stimulating neural mechanisms through visual feedback. Recent technological advancements, particularly in virtual reality (VR), have enabled the development of more immersive and interactive rehabilitation tools. This study focuses on evaluating the usability of a novel, Leap Motion-based Virtual Reality Mirror Therapy (VRMT) system designed to enhance upper limb rehabilitation in stroke patients by combining traditional mirror therapy principles with engaging, gamified digital environments.

Conditions

Stroke; Healthy

Keywords

Virtual Reality; Mirror Therapy

Outcome Measures

Primary Outcomes (1)

• Simulator Sickness Questionnaire

  "The SSQ evaluates 16 symptoms-including eye strain, nausea, sweating, and headache-using a four-point scale (none, mild, moderate, and severe). These symptoms are categorized into three overlapping subscales: nausea, oculomotor discomfort, and disorientation. Higher scores within each subscale reflect more intense experiences of simulator sickness. In military aviation contexts, a total SSQ score above 20 is typically interpreted as indicative of poor tolerance to simulation exposure. The total score generally ranges from 0 to 30, with higher scores indicating lower tolerance to simulated environments.

  One hour

Secondary Outcomes (4)

• Presence Questionnaire

  One hour

• Virtual Reality Sickness Questionnaire

  One hour

• System Usability Scale

  One hour

• Virtual Reality System Usability Questionnaire

  One hour

Study Arms (2)

Virtual Reality Mirror Therapy Group

EXPERIMENTAL

Participants will receive virtual reality mirror therapy using head-mounted devices.

Other: Virtual Reality Mirror Therapy

Sham Group

SHAM COMPARATOR

Participants will receive conventional mirror therapy with mirror box and then experience mirrored hand activities in virtual reality environment.

Other: Conventional Mirror Therapy; Other: Sham Virtual Reality

Interventions

Conventional Mirror Therapy OTHER

Participants will be seated on a chair with back support, their feet in contact with the ground, and both arms placed on a table. Activities to be practiced during the session will include wrist flexion and extension, forearm pronation and supination, finger flexion and extension, finger opposition movements, squeezing a cloth, grasping a round object, wiping a table, and object manipulation. The therapy program will follow a progression from simple to complex and functional movements throughout the session. Session will begin with basic exercises such as flexion and extension movements of the fingers, wrist, and elbow, with 10 repetitions for each movement.

Sham Group

Sham Virtual Reality OTHER

Participants will experience virtual environments while seated and wearing a virtual reality headset, without interacting with the environment. The sham mirror therapy session will consist of two 15-minute segments with a 10-minute rest period in between.

Sham Group

Virtual Reality Mirror Therapy OTHER

Participants will be seated on a chair with back support, their feet in contact with the ground, and both arms placed on a table. Data from participants' right forearms will be collected using Leap Motion tracking. In the virtual reality environment, both the original and mirrored forearms will be displayed within the participants' field of view. The mirror therapy session will consist of two 15-minute segments with a 10-minute rest period in between. Activities to be practiced during the session will include wrist flexion and extension, forearm pronation and supination, finger flexion and extension, finger opposition movements, squeezing a cloth, grasping a round object, wiping a table, and object manipulation. The therapy program will follow a progression from simple to complex and functional movements throughout the session. Session will begin with basic exercises such as flexion and extension movements of the fingers, wrist, and elbow, with 10 repetitions for each movement.

Virtual Reality Mirror Therapy Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Stereo acuity score of 3552 arc/sec in the Titmus Fly Test
• No prior virtual reality experience

You may not qualify if:

• Severe sensory impairments (vision or hearing)
• Being diagnosed with neurological disorders

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (2)

Faculty of Health Sciences Bolu Abant Izzet Baysal University

Bolu, Merkez, 14100, Turkey (Türkiye)

RECRUITING

Bolu Abant Izzet Baysal University Department of Physiotherapy and Rehabilitation

Bolu, 14300, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• ramazan kurul, Ph.D

  Abant Izzet Baysal University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ömer Pala, PhD

CONTACT

+90 532 797 57 16; omerosman.pala@ibu.edu.tr

ramazan kurul, PhD

CONTACT

+905436414731; ramazankurul@ibu.edu.tr

Study Design

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

Model Details: Prospective parallel group with single-blinded design

Study Record Dates

• First Submitted: June 18, 2025
• First Posted: June 26, 2025
• Study Start: June 28, 2025
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After publication, the study will be available indefinitely.
• Access Criteria: Researchers may submit a data request by contacting the corresponding author via email. Approved users will receive access through a secure, password-protected institutional data-sharing platform or encrypted file transfer.

Locations

TU (2)