NCT07520253

Brief Summary

The purposes of the study are:

  1. 1.To investigate the effect of virtual reality in patients with subacute stage of Stroke on cortical reorganization.
  2. 2.To investigate the effect of virtual reality in patients with subacute stage of Stroke on upper extremity functional recovery.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
6mo left

Started May 2026

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress19%
May 2026Dec 2026

First Submitted

Initial submission to the registry

December 31, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 9, 2026

Completed
22 days until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

April 9, 2026

Status Verified

April 1, 2026

Enrollment Period

7 months

First QC Date

December 31, 2025

Last Update Submit

April 7, 2026

Conditions

Keywords

Stroke

Outcome Measures

Primary Outcomes (3)

  • Upper Extremity Functional Recovery

    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

    6 months

  • Cortical Reorganization

    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.

    6 months

  • Gross manual dexterity

    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

    6 months

Study Arms (2)

Conventional physical therapy group ( Control Group ) ( Group I )

ACTIVE COMPARATOR

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

Other: Conventional physical therapy program

Virtual reality group (Study group) (Group II)

EXPERIMENTAL

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)

Other: Virtual RealityOther: Conventional physical therapy program

Interventions

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)

Also known as: Exergaming using Nintendo WII
Virtual reality group (Study group) (Group II)

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)

Conventional physical therapy group ( Control Group ) ( Group I )Virtual reality group (Study group) (Group II)

Eligibility Criteria

Age50 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy, Cairo University, Egypt

Cairo, 12613, Egypt

Location

Related Publications (2)

  • 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.

    PMID: 39357611BACKGROUND
  • 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.

    PMID: 34636735BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • ABEER ABO BAKR ABDELKADER ELWISHY ELWISHY, Professor of Physical Therapy

    Cairo University

    STUDY CHAIR

Central Study Contacts

MOHAMMED RAMADAN IBRAHIM MOHAMMED Mohammed, M.S.C

CONTACT

ABEER ABO BAKR ABDELKADER ELWISHY PROF. DR., Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mohammed

Study Record Dates

First Submitted

December 31, 2025

First Posted

April 9, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

April 9, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Because of patients privacy

Locations