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

Sponsor
Istanbul University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05869786
Collaborator
(none)
30
2
6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Virtual Reality Mediated Upper Extremity Rehabilitation (SensoRehab®)
  • Other: conventional rehabilitation program
  • Behavioral: Exercise
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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).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).
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Investigation of the Effect of Virtual Reality-Mediated Rehabilitation on Upper Extremity Functions in Ischemic Stroke Patients
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

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

Active Comparator: 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.

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.

Outcome Measures

Primary Outcome Measures

  1. Fugl-Meyer upper extremity scale [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 Outcome Measures

  1. Functional Independence Measure [Change from Baseline Functional Independence Measure at 3rd Month After Intervention]

    Participants' functional status will be assessed by Functional Independence Measure. In this scale, the functional status of patients is evaluated with 18 questions under 6 sub-headings, each question is scored between 1-7. Higher scores indicate better functional status.

  2. Handgrip Strength [Change from Baseline Handgrip Strength at 3rd Month After Intervention]

    The handgrip strength of the participants will be evaluated with a dynamometer.

  3. Modified Ashworth Scale [Change from Baseline Modified Ashworth Scale at 3rd Month After Intervention]

    Upper extremity muscle spasticity of the participants will be evaluated with the modified Ashworth Scale. According to this scale, spasticity is evaluated between 0-4. Higher points mean more spasticity.

  4. Stroke Impact Scale [Change from Baseline Stroke Impact Scale. at 3rd Month After Intervention]

    The quality of life of the participants will be evaluated with the Stroke Impact Scale.It consists of 8 subsections and 59 questions. Each question is scored by rating the difficulty experienced in the last week on a 5-point scale. The score for each section ranges from 0-100. Higher scores are associated with better quality of life.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Istanbul University

Investigators

  • Principal Investigator: AHmet Kivanc Menekseoglu, MD, Kanuni Sultan Suleyman Research and Training Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ahmet Kivanc Menekseoglu, Principal Investigator, Istanbul University
ClinicalTrials.gov Identifier:
NCT05869786
Other Study ID Numbers:
  • 2023.04.43
First Posted:
May 22, 2023
Last Update Posted:
May 23, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 23, 2023