Virtual Reality With Mirror Therapy on Upper Limb Function

Effect Of Virtual Reality With Mirror Therapy on Upper Limb Functions in Children With Hemiplegic Cerebral Palsy

The goal of this clinical trial is to address the effect of (Virtual Reality) and (Mirror Therapy) together on upper limb function in hemiplegic Cerebral Palsy children , male or female ranged between 3 to 10 years of age

. The main question of the study is Are there any significant differences between the effects of virtual reality , mirror therapy and the combined effect of both techniques and on upper limb function in hemiplegic CP children?

Participants will be subdevided into three groups A , B ,C Group (A): will receive VR in addition to designed physical therapy program Group (B): will receive MT in addition to designed physical therapy program Group (C): will receive the compound effect of both techniques in addition to designed physical therapy program

Study Overview

• Status: Not yet recruiting
• Conditions: Hemiplegic Cerebral Palsy
• Intervention / Treatment: Device: virtual reality; Other: mirror therapy; Other: virtual reality with mirror therapy

Detailed Description

The goal of this clinical trial is to address the effect of (Virtual Reality) and (Mirror Therapy) together on upper limb function in hemiplegic Cerebral Palsy children , male or female ranged between 3 to 10 years of age

. The main question of the study is Are there any significant differences between the effects of virtual reality (VR), mirror therapy (MR) and the combined effect of both techniques (VR) and (MR) on upper limb function in hemiplegic CP children?

Participants will be subdevided into three groups A , B ,C Group (A): will receive VR in addition to designed physical therapy program Group (B): will receive MT in addition to designed physical therapy program Group (C): will receive the compound effect of both techniques in addition to designed physical therapy program

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: khalid E mohamed, demonstrator; Phone Number: +201120190879; Email: khalid.esmail@acu.edu.eg

Study Locations

• Egypt
  • Kafr Ash Shaykh, Egypt
    • faculty of physical therapy Kafrelshiekh university
    • Contact: khalid E mohamed, demonstrator; Phone Number: +201120190879; Email: khalid.esmail@acu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Children will be included in the study if they fulfil the following criteria:

  1. A medical diagnosis of spastic hemiplegic CP made by pediatric neurologists.
  2. Children with spasticity grades ranged from 1 to 1+ according to MAS.
  3. Their age range from 4 to 10 years.
  4. Children level 1 and level 2 in gross motor functional classification (GMFC 1&2)

Exclusion Criteria:

• Children will be excluded from the study if:

  1. They had a permanent deformity (bony or soft tissue contractures).
  2. Children having visual or auditory defects.
  3. Children who can not understand verbal commands
  4. Children who had Botox application to the upper extremity in the past 6 months or had undergone a previous surgical intervention to wrist and hand.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group (A) virtual reality group; this group will receive virtual reality intervention plus designed physical therapy program	Device: virtual reality; In Xbox, we will choose suitable games that aim to improve upper limb function like boxing, Darts, tennis, goalkeeping, basketball, disc throwing, balling, and volleyball. The Kinect sensor has the advantage of auto adjustment of its camera according to the child's position and height that's to say the child can perform the game in sitting or standing according to their abilities. They will receive 30 minutes of VR intervention in addition to the time required for the designed physical therapy program.
Active Comparator: Group (B) mirror therapy group; this group will receive mirror therapy intervention plus designed physical therapy program	Other: mirror therapy; Mirror Therapy A mirror of 30 × 20 inches was used for the MT, which was large enough to cover the entire affected limb while still allowing the reflection of the non-affected limb to be seen. The child was seated in a chair with the forearms resting on the table. In the mid-sagittal plane, the mirror box was positioned at an angle of 70° to 80° to the trunk. The affected limb was placed behind the mirror. The child was asked to perform the exercises bilaterally and symmetrically as much as possible. Even if the affected side did not move easily or fully, the child was advised to synchronize the motions with both hands and arms. The researcher constantly reminded the child to concentrate on the movement of the non-affected limb in front of the mirror, which helped to increase the mirror illusion
Active Comparator: Group (C) the compound effect of virtual reality and mirror therapy group; this group will receive virtual reality intervention , mirror therapy intervention plus designed physical threrapy program	Other: virtual reality with mirror therapy; group C will receive combined effect of both techniques (virtual reality and mirror therapy)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes in upper limb functions	using quality of upper extremity skills test (Quest)	after 12 weeks of intervention
changes in power grip strength	using sphygmomanometer	after 12 weeks of intervention
changes in range of motion (ROM)	using kinovea software	after 12 weeks of intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes in activity of daily living (ADL)	using functional independence measure for children (WeeFIM):	after 12 weeks of intervention

Collaborators and Investigators

• Sponsor: Kafrelsheikh University
• Investigators: Study Chair: Mohamed B Ibrahim, Ass.Prof., head of pediatric department in faculty of physical therapy Kafrelshiekh university; Study Director: Osama A El-Agamy, Professor, Professor and head of department of pediatric department Faculty of medicine Kafrelshiekh university; Study Director: Sara Y Abdel Elglil, Lecturer, Lecturer in pediatric department in faculty of physical therapy Kafrelshiekh University

Publications and helpful links

General Publications

• Atasavun Uysal S, Baltaci G. Effects of Nintendo Wii Training on Occupational Performance, Balance, and Daily Living Activities in Children with Spastic Hemiplegic Cerebral Palsy: A Single-Blind and Randomized Trial. Games Health J. 2016 Oct;5(5):311-317. doi: 10.1089/g4h.2015.0102. Epub 2016 Oct 5.

Study record dates

Study Major Dates

• Study Start (Estimated): December 10, 2024
• Primary Completion (Estimated): March 10, 2025
• Study Completion (Estimated): March 15, 2025

Study Registration Dates

• First Submitted: December 6, 2024
• First Submitted That Met QC Criteria: December 6, 2024
• First Posted (Estimated): December 11, 2024

Study Record Updates

• Last Update Posted (Estimated): December 11, 2024
• Last Update Submitted That Met QC Criteria: December 6, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Upper limb function; Virtual reality; Mirror therapy; Hemiplagia; Xbox 360
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: KFSIRB200-254

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No