The Effect of Virtual Reality-Mediated Rehabilitation in Ischemic Stroke Patients

NCT ID: NCT05869786

Last Updated: 2024-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2024-01-01

Brief Summary

The aim of the study was to investigate the effectiveness of virtual reality-mediated upper extremity rehabilitation added to the conventional rehabilitation program on upper extremity, quality of life, range of motion and spasticity in patients with stroke.

Detailed Description

This prospective, randomized and controlled study will be conducted with patients diagnosed with stroke. Among the patients who are admitted to outpatient or inpatient rehabilitation program in SBU Kanuni Sultan Süleyman PMR clinic, 30 patients diagnosed with stroke who meet the inclusion criteria will be included in the study. Patients diagnosed with stroke will be randomized into two groups using a computer program (Virtual reality group, control group). Participants in both groups will receive a conventional rehabilitation program. Participants in the virtual reality group will receive virtual reality-mediated upper extremity rehabilitation for 3 weeks, 5 sessions per week, each session lasting 30 minutes (total 450 minutes). In the virtual reality intervention, participants will be asked to control the games with hand, wrist and forearm movements in front of a computer screen in front of the SensoRehab® sensor that can detect hand movements through gloves. 3 different games will be intervened for 10 minutes each, totaling 30 minutes per day.

Participants in the control group will be instructed in hand, finger, wrist and forearm therapeutic exercises by a physiotherapist.

After the intervention, patients will be evaluated in terms of upper extremity functions, quality of life, range of motion and spasticity.

All evaluations will be repeated before, after and 3 months after the intervention. Routine 3-month PMR outpatient clinic control is recommended for patients with stroke. Therefore, no additional hospital visit is requested from the patients due to the study.

Conditions

Hemiplegia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Virtual Reality Group

Participants in both groups will receive a conventional rehabilitation program. Participants in the virtual reality group will receive virtual reality-mediated upper extremity rehabilitation for 3 weeks, 5 sessions per week, each session lasting 30 minutes (450 minutes in total). In the virtual reality intervention, participants will be asked to control the games with hand, wrist and forearm movements in front of a computer screen in front of the SensoRehab® sensor that can detect hand movements through gloves. 3 different games will be intervened for 10 minutes each, totaling 30 minutes per day.

Group Type: EXPERIMENTAL

Virtual Reality Mediated Upper Extremity Rehabilitation (SensoRehab®)

Intervention Type: DEVICE

In the virtual reality intervention, participants will be asked to control the games with hand, wrist and forearm movements in front of a computer screen in front of the SensoRehab® sensor that can detect hand movements through gloves.

conventional rehabilitation program

Intervention Type: OTHER

conventional rehabilitation program

Control Group

Participants in the control group will be instructed in hand, finger, wrist and forearm therapeutic exercises by a physiotherapist. Participants in both groups will receive a conventional rehabilitation program.

Group Type: ACTIVE_COMPARATOR

conventional rehabilitation program

Intervention Type: OTHER

conventional rehabilitation program

Exercise

Intervention Type: BEHAVIORAL

Participants in the control group will be instructed in hand, finger, wrist and forearm therapeutic exercises by a physiotherapist.

Interventions

Virtual Reality Mediated Upper Extremity Rehabilitation (SensoRehab®)

In the virtual reality intervention, participants will be asked to control the games with hand, wrist and forearm movements in front of a computer screen in front of the SensoRehab® sensor that can detect hand movements through gloves.

Intervention Type: DEVICE

conventional rehabilitation program

conventional rehabilitation program

Intervention Type: OTHER

Exercise

Participants in the control group will be instructed in hand, finger, wrist and forearm therapeutic exercises by a physiotherapist.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 18 to 65 years of age,
• History of Ischemic Stroke
• Accept to participate in the study,

Exclusion Criteria

• Presence of known central nervous system or peripheral nervous system disease other than stroke, presence of progressive neurologic deficit,
• Uncontrolled hypertension, diabetes, cardiovascular disease etc.
• Cognitive impairment causing difficulty in executing simple commands
• Epilepsy
• Botulinum toxin application to the upper extremity in the last 6 months
• Change in the medical treatment used for spasticity in the last 6 months
• Pregnancy.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul University

OTHER

Sponsor Role: lead

Responsible Party

Ahmet Kivanc Menekseoglu

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

AHmet Kivanc Menekseoglu, MD

Role: PRINCIPAL_INVESTIGATOR

Kanuni Sultan Suleyman Research and Training Hospital

Locations

Ahmet Kıvanç Menekşeoğlu

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2023.04.43

Identifier Type: -

Identifier Source: org_study_id