NCT05869786

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

Investigation of the Effect of Virtual Reality-Mediated Rehabilitation on Upper Extremity Functions in Ischemic Stroke Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Istanbul University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	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.
OTHER	conventional rehabilitation program	conventional rehabilitation program
BEHAVIORAL	Exercise	Participants in the control group will be instructed in hand, finger, wrist and forearm therapeutic exercises by a physiotherapist.

Timeline

• Start date: 2023-05-01
• Primary completion: 2024-01-01
• Completion: 2024-01-01
• First posted: 2023-05-22
• Last updated: 2024-02-20

Locations

1 site across 1 country: Turkey (Türkiye)

Regulatory

• FDA-regulated device study