Effect of Motor Imagery With Virtual Reality in Patients With Stroke

NCT04215679 | Recruiting DMC

• 1 other identifier: AIBU-FTR-RK-05
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Virtual reality applications in hemiplegia rehabilitation are gaining popularity. It is claimed that, apart from implementing a function, imagining that function can trigger synaptic connections.

Conditions

Stroke

Keywords

Virtual reality; Rehabilitation

Outcome Measures

Primary Outcomes (2)

• Jebsen Hand Function Test

  The test consists of 7 subtitles and is an objective and standardized test. The test consists of 7 subtitles: "writing a standard sentence", "flipping 5 cards", "picking up small objects", "feeding simulation", "arranging backgammon checkers", "carrying large light objects" and "carrying large heavy objects". The score of the test is the completion time of the test and is recorded in seconds

  6 weeks

• Action Reach Arm Test (ARAT)

  This scale is scored between 0-57 points and consists of 4 headings: gross grip, fine grip, fingertip grip, and gross motion. Each part is calculated over 3 points. 3 points mean that the test is done in a normal way, 2 points show the difficulty and abnormally long time for doing it, 1 point means that individual can partially complete the test and 0 points can not complete the test. The higher the score, the better the level.

  6 weeks

Secondary Outcomes (2)

• Stroke impact scale (SIS)

  6 weeks

• Kinesthetic and visual imagery questionnaire

  6 weeks

Study Arms (3)

Three-dimensional immersive virtual reality application

EXPERIMENTAL

25 stroke patients between the ages of 18-80, stroke duration of less than 2 months and not more than 2 years whose mini Mental State Examination (MMSE) scores equal or above the 25 will be included in this study. Oculus Rift and Leap motion will be used to create an immersive interactive environment. Modified Ashworth Scale (MAS), Functional independence scale, self-care questionnaire,Action Research Arm Test, Fugl meyer upper extremity motor evaluations will be applied just before the rehabilitation program, after the application and at the end of 6 weeks.

Other: Three-dimensional immersive virtual reality application

Motor imagery

ACTIVE COMPARATOR

25 stroke patients between the ages of 18-80, stroke duration of less than 2 months and not more than 2 years whose MMSE scores equal or above the 25 will be included in this study. Oculus Rift and Leap motion will be used to create an immersive interactive environment. Modified Ashworth Scale (MAS), Functional independence scale, self-care questionnaire,Action Research Arm Test, Fugl meyer upper extremity motor evaluations will be applied just before the rehabilitation program, after the application and at the end of 6 weeks.

Other: Motor imagery

Conventional physiotherapy

ACTIVE COMPARATOR

25 stroke patients between the ages of 18-80, stroke duration of less than 2 months and not more than 2 years whose MMSE scores equal or above the 25 will be included in this study. Oculus Rift and Leap motion will be used to create an immersive interactive environment. Modified Ashworth Scale (MAS), Functional independence scale, self-care questionnaire,Action Research Arm Test, Fugl meyer upper extremity motor evaluations will be applied just before the rehabilitation program, after the application and at the end of 6 weeks.

Other: Conventional physiotherapy

Interventions

Three-dimensional immersive virtual reality application OTHER

In this group, individuals will be included in a game program that will last for 3 days a week for a total of 6 weeks and 45 minutes a day. Individuals will use the IVR to rehabilitate functions that are frequently used in daily life through task-oriented games. The IVR device will be placed on the head of the individual by closing the eyes of the individual and the Leap Motion device will be used to enable individuals to see their own hands in a virtual reality environment. In order to ensure the safety of individuals, practices shall be carried out with the individual sitting in the chair and leaning against the back. A total of 3 different games will be used for upper extremity function, each game will be 15 minutes and the total session time will be 45 minutes.

Three-dimensional immersive virtual reality application

Motor imagery OTHER

Motor imagery will be performed with the eyes closed. In addition, for the safety of the individual, the individual will sit comfortably in a chair in a quiet environment and sit back. In the motor imagery group, individuals will be shown videos of the 3 games for 2 times in the IVR group and will be asked to imagine that they perform the same functions in the IVR games. The motor imagery will be 3 days a week for a total of 6 weeks and 45 minutes per day (including rest periods).

Motor imagery

Conventional physiotherapy OTHER

Individuals in this group will be randomly recruited from hospitalized stroke volunteers. Since these individuals receive routine rehabilitation 5 days a week, they will be evaluated at the beginning and end of 18 sessions over a total period of 6 weeks. Conventional physiotherapy will include normal joint movements, muscle strengthening exercises, balance and mobility exercises, and exercises to improve daily life activity.

Conventional physiotherapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed as stroke patient.
• Speaks, reads and writes in Turkish.
• Hand functions at 4, 5, 6 levels according to Brunnstrom.
• Mini mental test score to be at least 24.
• Volunteer for participation.

You may not qualify if:

• Neurological, orthopedic problems other than stroke.
• To have motion sickness that cannot continue 3D application.
• Individuals neglecting the affected side

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (1)

Abant Izzet Baysal University

Bolu, Merkez, 14100, 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

• Mustafa Fatih Yaşar, MD

  Bolu Abant Izzet Baylsa University

  PRINCIPAL INVESTIGATOR

• Ramazan KURUL, Ph.D

  Bolu Abant Izzet Baylsa University

  PRINCIPAL INVESTIGATOR

• Muhammed Nur Ögün, MD

  Bolu Abant Izzet Baylsa University

  PRINCIPAL INVESTIGATOR

• Şebnem AVCI, Ph.D

  Bolu Abant Izzet Baylsa University

  STUDY DIRECTOR

Central Study Contacts

Şebnem AVCI, Ph.D

CONTACT

+905057811059; avciseb@hotmail.com

Ramazan KURUL, Ph.D

CONTACT

+905436414731; ramazankurul2@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participant will be evaluated at baseline, 6 weeks later by an another investigator who does not aware of groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: The first group of the study is immersive virtual reality therapy (IVR), the second group is motor imagery therapy (MI), and the third group is the conventional physiotherapy group (CG).

Study Record Dates

• First Submitted: December 30, 2019
• First Posted: January 2, 2020
• Study Start: December 1, 2021
• Primary Completion: March 1, 2026
• Study Completion: May 1, 2026
• Last Updated: June 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)