- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07520253
Effect of Virtual Reality on Cortical Reorganization and Upper Extremity Functional Recovery in Patients With Subacute Stroke
Effect Of Virtual Reality On Cortical Reorganization And Upper Extremity Functional Recovery In Patients With Subacute Stroke
The purposes of the study are:
- To investigate the effect of virtual reality in patients with subacute stage of Stroke on cortical reorganization.
- To investigate the effect of virtual reality in patients with subacute stage of Stroke on upper extremity functional recovery.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: MOHAMMED RAMADAN IBRAHIM MOHAMMED Mohammed, M.S.C
- Phone Number: +201004345510
- Email: mohammed.ramadan@the.Suezuni.edu.eg
Study Contact Backup
- Name: ABEER ABO BAKR ABDELKADER ELWISHY PROF. DR., Professor
- Phone Number: +201228088835
- Email: abeer.elwishy@pt.cu.edu.eg
Study Locations
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-
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Cairo, Egypt, 12613
- Faculty of Physical Therapy, Cairo University, Egypt
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
• Age ranges from 50 to 65 years.
- Both sexes (male and female).
- First stroke ever (ischemic or hemorrhagic) within the last three months.
- Clinical diagnosis of subacute stroke confirmed by neuroimaging (CT / MRI).
- Hemiparetic shoulder power more than three according to Medical Research Council Scale (MRC) (James, 2007).
- Patients who are able to manipulate the Wii remote control.
- Muscle tone grade 1 to 1+ (Mild to Moderate) spasticity for shoulder joint according to Modified Ashworth Scale (Meseguer et al., 2018).
- Participants are in normal cognitive and psychological status according to Montreal Cognitive Assessment screening (Hawkins et al., 2014).
Exclusion Criteria:
• Patients having severe arm or shoulder pain or symptomatic shoulder sublaxation.
- Contractures or shoulder deformities.
- Patients who have previous experience in using Wii.
- Patients with problems that may interfere with using Wii suchas epilepsy, visual impairments, apraxia and/or spatial neglect
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Conventional physical therapy group ( Control Group ) ( Group I )
Patients will have conventional physical therapy program as follow : Range of motion (ROM) and stretching begin with passive ROM to all joints of the upper limb (10 repetitions × 2 sets), followed by active-assisted ROM using a stick or the unaffected limb. Stretching is performed for 30-60 seconds, 3-5 repetitions.Strengthening exercises focus on isometric contractions of scapular stabilizers, deltoid, and biceps/triceps, holding 5-10 seconds × 10 repetitions, along with isotonic exercises using therabands or light weights (0.5-1 kg) for 8-12 repetitions × 2-3 sets. Activities of daily living (ADL) training involve self-care practices including grooming, eating, and buttoning, as well as task-specific training such as reaching, grasping, and releasing real objects. Each ADL task is practiced for 15-20 minutes, with 1-2 tasks per session.Scapular stability exercises include graded practice with large to small objects, bimanual training will be applied to both groups |
Patients will have conventional physical therapy program as follow : Range of motion (ROM) and stretching begin with passive ROM to all joints of the upper limb (10 repetitions × 2 sets), followed by active-assisted ROM using a stick or the unaffected limb. Stretching is performed for 30-60 seconds, 3-5 repetitions.Strengthening exercises focus on isometric contractions of scapular stabilizers, deltoid, and biceps/triceps, holding 5-10 seconds × 10 repetitions, along with isotonic exercises using therabands or light weights (0.5-1 kg) for 8-12 repetitions × 2-3 sets. Activities of daily living (ADL) training involve self-care practices including grooming, eating, and buttoning, as well as task-specific training such as reaching, grasping, and releasing real objects. Each ADL task is practiced for 15-20 minutes, with 1-2 tasks per session.Scapular stability exercises include graded practice with large to small objects, bimanual training (e.g., holding a bowl while stirring) |
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Experimental: Virtual reality group (Study group) (Group II)
This group will be treated by conventional physical therapy program in addition to virtual reality using Nintendo Wii Group II (study group) will receive the same treatment as group I in addition to exergaming technology using Nintendo Wii.
The Wii program will be of game based VR movement therapy using the Wii for one hour each session.
Three games will be selected from the Wii sports and Wii Fit packages for upper limb.
Participants who could not grip the controller, a bandage will be used to fix the controller on to the affected hand.
Games like; Tennis, Baseball, Golf club and Boxing.
The patient will select three games from Wii sports (Tennis- Golf- Boxing-Baseball) then patients will be given a trial of playing each game to be familiar with it after that they will be given one hour practice 20 minutes for each game for six weeks and three times per week (18 sessions)
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Patients will have conventional physical therapy program as follow : Range of motion (ROM) and stretching begin with passive ROM to all joints of the upper limb (10 repetitions × 2 sets), followed by active-assisted ROM using a stick or the unaffected limb. Stretching is performed for 30-60 seconds, 3-5 repetitions.Strengthening exercises focus on isometric contractions of scapular stabilizers, deltoid, and biceps/triceps, holding 5-10 seconds × 10 repetitions, along with isotonic exercises using therabands or light weights (0.5-1 kg) for 8-12 repetitions × 2-3 sets. Activities of daily living (ADL) training involve self-care practices including grooming, eating, and buttoning, as well as task-specific training such as reaching, grasping, and releasing real objects. Each ADL task is practiced for 15-20 minutes, with 1-2 tasks per session.Scapular stability exercises include graded practice with large to small objects, bimanual training (e.g., holding a bowl while stirring)
Twenty patients with subacute stroke will receive conventional physical therapy program and virtual reality through Nintendo Wii The patient will hold the Wii remote in his hand to move the Avatar on the screen and practice the exercise Figure.6.
If the patient cannot hold the Wii remote in his hand it will be strapped to his hand.
A full instruction according to every game will be explained to the patients explaining every game rules and how to perform and what is the goal of each game.
The patient will have one trial in every game to perform before setting the time.
Screen /projector will be positioned at eye level of each patient and a Chair for sitting or standing according to the patient, The patient will select three games from Wii sports (Tennis- Golf- Boxing-Baseball) then patients will be given a trial of playing each game to be familiar with it after that they will be given one hour practice 20 minutes for each game for six weeks and three times per week (18 sessions)
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Upper Extremity Functional Recovery
Time Frame: 6 months
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Upper Extremity Functional Recovery will be assessed by Chedoke Arm and Hand Activity Inventory-7 item version (CAHAI-7).
CAHAI-7 assesses the affected arm and hand during bilateral tasks by asking the person to complete seven specific activities.
Each item of the CAHAI is scored on a 7-point quantitative scale ranging from 7 to 49, with higher scores reflecting greater functional recovery
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6 months
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Cortical Reorganization
Time Frame: 6 months
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Cortical Reorganization will be assessed by Quantitative Electroencephalography (QEEG) QEEG indices can give meaningful prognostic information of motor and functional recovery in patients with stroke.
Delta Alpha Ratio (DAR) and Delta Theta to Alpha Beta Ratio (DTABR) are quantitative EEG (QEEG) indices used to measure brain electrical activity.
Lower values of DAR and DTABR are associated with better recovery in patients with brain injury.
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6 months
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Gross manual dexterity
Time Frame: 6 months
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Gross manual dexterity will be assessed by Box and Block test (BBT).
BBT contains a wooden box that is divided into two sections and the patient is asked to move the blocks from one side of to the other side.
The BBT score represents the number of blocks successfully moved from one side of the box to the other within 60 seconds.
A higher score indicates greater manual dexterity
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6 months
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: ABEER ABO BAKR ABDELKADER ELWISHY ELWISHY, Professor of Physical Therapy, Cairo University
Publications and helpful links
General Publications
- Sood I, Injety RJ, Farheen A, Kamali S, Jacob A, Mathewson K, Buck BH, Kate MP. Quantitative electroencephalography to assess post-stroke functional disability: A systematic review and meta-analysis. J Stroke Cerebrovasc Dis. 2024 Dec;33(12):108032. doi: 10.1016/j.jstrokecerebrovasdis.2024.108032. Epub 2024 Sep 30.
- Wu J, Zeng A, Chen Z, Wei Y, Huang K, Chen J, Ren Z. Effects of Virtual Reality Training on Upper Limb Function and Balance in Stroke Patients: Systematic Review and Meta-Meta-Analysis. J Med Internet Res. 2021 Oct 12;23(10):e31051. doi: 10.2196/31051.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/006118
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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