Effect of Motor Imagery With Virtual Reality in Patients With Stroke

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04215679
• Other study ID #: AIBU-FTR-RK-05
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: May 1, 2024

Study information

• Verified date: September 2023
• Source: Abant Izzet Baysal University
• Contact: Sebnem AVCI, Ph.D
• Phone: +905057811059
• Email: avciseb[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: May 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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.
• 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).
• 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.

Locations

Country	Name	City	State
Turkey	Abant Izzet Baysal University	Bolu	Merkez

Sponsors (1)

Lead Sponsor	Collaborator
Abant Izzet Baysal University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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	6 weeks
Secondary	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.	6 weeks