Effect of Motor Imagery With Virtual Reality in Patients With Stroke

September 22, 2023 updated by: Ramazan KURUL, Abant Izzet Baysal University

Comparison of Three Dimensional Virtual Reality Therapy and Motor Imaging in Functional Recovery of Upper Extremity After Stroke

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Although the effects of non-three-dimensional virtual reality and motor imagination on the brain have been investigated in a study, such comparison has not been made between the three-dimensional virtual reality and motor imagery.

Considering these situations, the aim of this study is to compare the effect of three-dimensional (immersive) virtual reality and motor imagery on upper extremity functional recovery after stroke.

Study Type

Interventional

Enrollment (Estimated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
    • Merkez
      • Bolu, Merkez, Turkey, 14100
        • Recruiting
        • Abant Izzet Baysal University
        • Principal Investigator:
          • Muhammed Nur Öğün, M.D.
        • Principal Investigator:
          • Şebnem Avcı, Ph.D
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ramazan Kurul, Ph.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Three-dimensional immersive virtual reality application
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
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.
Active Comparator: Motor imagery
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
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).
Active Comparator: Conventional physiotherapy
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Jebsen Hand Function Test
Time Frame: 6 weeks
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)
Time Frame: 6 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stroke impact scale (SIS)
Time Frame: 6 weeks
Turkish validity was done by Hantal et al. in 2014. It is a 9-stage scale that is scored between 0-57 points, with a higher score indicating a better condition and a lower score indicating a higher severity of stroke. Scoring is done separately for each title
6 weeks
Kinesthetic and visual imagery questionnaire
Time Frame: 6 weeks
It was developed in 2007 by Malouin et al. In this method, the participant is told about the desired movement and is asked to do so. Then the participant is asked to imagine as if he was watching the movement without making any movement. It is scored between 1-5 points. 1: no image, 5: as clear as the original. At the other stage, he is asked to imagine himself by feeling what he is doing and is scored between 1 and 5 points. 1 point: no sense, 5 points mean intense feeling as if he is making the move. The scale assesses both visual and kinesthetic imagery with each dimension being scored from 5 to 25 with higher scores indicating greater imagery clarity or intensity.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abant Izzet Baysal University

Investigators

  • Principal Investigator: Muhammed Nur Ögün, MD, Bolu Abant Izzet Baylsa University
  • Study Director: Şebnem AVCI, Ph.D, Bolu Abant Izzet Baylsa University
  • Principal Investigator: Mustafa Fatih Yaşar, MD, Bolu Abant Izzet Baylsa University
  • Principal Investigator: Ramazan KURUL, Ph.D, Bolu Abant Izzet Baylsa University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2021

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

May 1, 2024

Study Registration Dates

First Submitted

December 30, 2019

First Submitted That Met QC Criteria

December 30, 2019

First Posted (Actual)

January 2, 2020

Study Record Updates

Last Update Posted (Actual)

September 25, 2023

Last Update Submitted That Met QC Criteria

September 22, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AIBU-FTR-RK-05

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stroke

Clinical Trials on Three-dimensional immersive virtual reality application

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Tanzania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe