Effect of Motor Imagery With Virtual Reality in Patients With Stroke

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

Turkey

Study Type

Interventional

Intervention

Three-dimensional immersive virtual reality application

Motor imagery

Conventional physiotherapy

About this trial

This is an interventional treatment trial for Stroke focused on measuring Virtual reality, Rehabilitation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Abant Izzet Baysal UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Three-dimensional immersive virtual reality application

Motor imagery

Conventional physiotherapy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

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.

Secondary Outcome Measures

Stroke impact scale (SIS)

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

Kinesthetic and visual imagery questionnaire

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.

Full Information

NCT ID

NCT04215679

First Posted

December 30, 2019

Last Updated

September 22, 2023

Sponsor

Abant Izzet Baysal University

1. Study Identification

Unique Protocol Identification Number

NCT04215679

Brief Title

Effect of Motor Imagery With Virtual Reality in Patients With Stroke

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 1, 2021 (Actual)

Primary Completion Date

March 1, 2024 (Anticipated)

Study Completion Date

May 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Abant Izzet Baysal University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke

Keywords

Virtual reality, Rehabilitation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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).

Masking

Outcomes Assessor

Masking Description

Participant will be evaluated at baseline, 6 weeks later by an another investigator who does not aware of groups.

Allocation

Randomized

Enrollment

36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Three-dimensional immersive virtual reality application

Arm Type

Experimental

Arm Description

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.

Arm Title

Motor imagery

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Conventional physiotherapy

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

Three-dimensional immersive virtual reality application

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Motor imagery

Intervention Description

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).

Intervention Type

Other

Intervention Name(s)

Conventional physiotherapy

Intervention Description

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.

Primary Outcome Measure Information:

Title

Jebsen Hand Function Test

Description

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

Time Frame

6 weeks

Title

Action Reach Arm Test (ARAT)

Description

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.

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

Stroke impact scale (SIS)

Description

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

Time Frame

6 weeks

Title

Kinesthetic and visual imagery questionnaire

Description

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.

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Şebnem AVCI, Ph.D

Phone

+905057811059

Email

avciseb@hotmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Ramazan KURUL, Ph.D

Phone

+905436414731

Email

ramazankurul2@hotmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mustafa Fatih Yaşar, MD

Organizational Affiliation

Bolu Abant Izzet Baylsa University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Ramazan KURUL, Ph.D

Organizational Affiliation

Bolu Abant Izzet Baylsa University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Muhammed Nur Ögün, MD

Organizational Affiliation

Bolu Abant Izzet Baylsa University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Şebnem AVCI, Ph.D

Organizational Affiliation

Bolu Abant Izzet Baylsa University

Official's Role

Study Director

Facility Information:

Facility Name

Abant Izzet Baysal University

City

Bolu

State/Province

Merkez

ZIP/Postal Code

14100

Country

Turkey

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Muhammed Nur ÖĞÜN, M.D

Phone

+905072329466

Email

dr.mogun@gmail.com

First Name & Middle Initial & Last Name & Degree

Ramazan Kurul, Ph.D

Phone

+905436414731

Email

ramazankurul2@hotmail.com

First Name & Middle Initial & Last Name & Degree

Ramazan Kurul, Ph.D

First Name & Middle Initial & Last Name & Degree

Muhammed Nur Öğün, M.D.

First Name & Middle Initial & Last Name & Degree

Şebnem Avcı, Ph.D

12. IPD Sharing Statement

Plan to Share IPD

No

Stroke

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial