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

Primary Purpose

Hemiplegia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Virtual Reality Mediated Upper Extremity Rehabilitation (SensoRehab®)
conventional rehabilitation program
Exercise
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemiplegia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Virtual Reality Group

    Control Group

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Fugl-Meyer upper extremity scale
    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

    Functional Independence Measure
    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.
    Handgrip Strength
    The handgrip strength of the participants will be evaluated with a dynamometer.
    Modified Ashworth Scale
    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.
    Stroke Impact Scale
    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.

    Full Information

    First Posted
    April 18, 2023
    Last Updated
    May 21, 2023
    Sponsor
    Istanbul University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05869786
    Brief Title
    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

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 1, 2023 (Anticipated)
    Primary Completion Date
    November 1, 2023 (Anticipated)
    Study Completion Date
    December 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Istanbul University

    4. Oversight

    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
    Data Monitoring Committee
    No

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hemiplegia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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).
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Virtual Reality Group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control Group
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Virtual Reality Mediated Upper Extremity Rehabilitation (SensoRehab®)
    Intervention Description
    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
    Other
    Intervention Name(s)
    conventional rehabilitation program
    Intervention Description
    conventional rehabilitation program
    Intervention Type
    Behavioral
    Intervention Name(s)
    Exercise
    Intervention Description
    Participants in the control group will be instructed in hand, finger, wrist and forearm therapeutic exercises by a physiotherapist.
    Primary Outcome Measure Information:
    Title
    Fugl-Meyer upper extremity scale
    Description
    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.
    Time Frame
    Change from Baseline Fugl-Meyer upper extremity scale at 3rd Month After Intervention
    Secondary Outcome Measure Information:
    Title
    Functional Independence Measure
    Description
    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.
    Time Frame
    Change from Baseline Functional Independence Measure at 3rd Month After Intervention
    Title
    Handgrip Strength
    Description
    The handgrip strength of the participants will be evaluated with a dynamometer.
    Time Frame
    Change from Baseline Handgrip Strength at 3rd Month After Intervention
    Title
    Modified Ashworth Scale
    Description
    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.
    Time Frame
    Change from Baseline Modified Ashworth Scale at 3rd Month After Intervention
    Title
    Stroke Impact Scale
    Description
    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.
    Time Frame
    Change from Baseline Stroke Impact Scale. at 3rd Month After Intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ahmet Kivanc Menekseoglu, MD
    Phone
    +905378192424
    Email
    kivancmenekseoglu@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    AHmet Kivanc Menekseoglu, MD
    Organizational Affiliation
    Kanuni Sultan Suleyman Research and Training Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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