Clinical trial NCT05869786: The Effect of Virtual Reality-Mediated Rehabilitation in Ischemic Stroke Patients
Official title: Investigation of the Effect of Virtual Reality-Mediated Rehabilitation on Upper Extremity Functions in Ischemic Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemiplegia
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2023-05-22
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model 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 PTR 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).
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Fugl-Meyer upper extremity scale
timeFrame: Change from Baseline Fugl-Meyer upper extremity scale at 3rd Month After Intervention
Secondary outcomes:
measure: Functional Independence Measure
timeFrame: Change from Baseline Functional Independence Measure at 3rd Month After Intervention
measure: Handgrip Strength
timeFrame: Change from Baseline Handgrip Strength at 3rd Month After Intervention
measure: Modified Ashworth Scale
timeFrame: Change from Baseline Modified Ashworth Scale at 3rd Month After Intervention
measure: Stroke Impact Scale
timeFrame: Change from Baseline Stroke Impact Scale. at 3rd Month After Intervention
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Ahmet Kıvanç Menekşeoğlu
Study officials:
affiliation: Kanuni Sultan Suleyman Research and Training Hospital
name: AHmet Kivanc Menekseoglu, MD
role: PRINCIPAL_INVESTIGATOR
References: