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Clinical Trials/NCT05869786
NCT05869786
Completed
N/A

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

Istanbul University1 site in 1 country32 target enrollmentMay 1, 2023
ConditionsHemiplegia

Overview

Phase
N/A
Intervention
Not specified
Conditions
Hemiplegia
Sponsor
Istanbul University
Enrollment
32
Locations
1
Primary Endpoint
Fugl-Meyer upper extremity scale
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2023
End Date
January 1, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ahmet Kivanc Menekseoglu

Principal Investigator

Istanbul University

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
  • 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.

Outcomes

Primary Outcomes

Fugl-Meyer upper extremity scale

Time Frame: Change from Baseline Fugl-Meyer upper extremity scale at 3rd Month After Intervention

This scale is a stroke-specific, performance-based scale and each parameter is scored as 0; unsuccessful, 1; partially successful and 2; completely successful performance. This scale consists of five sections: motor function, balance, sensation, range of motion and pain. The motor function assessment section is scored as 100 points (66 upper extremities and 34 lower extremities), sensation (light touch and position sense) 24 points, balance (6 sitting and 8 standing) 14 points, range of motion 44 points and joint pain 44 points.

Secondary Outcomes

  • Functional Independence Measure(Change from Baseline Functional Independence Measure at 3rd Month After Intervention)
  • Handgrip Strength(Change from Baseline Handgrip Strength at 3rd Month After Intervention)
  • Stroke Impact Scale(Change from Baseline Stroke Impact Scale. at 3rd Month After Intervention)
  • Modified Ashworth Scale(Change from Baseline Modified Ashworth Scale at 3rd Month After Intervention)

Study Sites (1)

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