Virtual Reality With Mirror Therapy on Upper Limb Function

NCT06728475 | Not Yet Recruiting

• 1 other identifier: KFSIRB200-254
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hemiplegic Cerebral Palsy

Keywords

Hemiplagia; Upper limb function; Virtual reality; Mirror therapy; Xbox 360

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• changes in activity of daily living (ADL)

  after 12 weeks of intervention

Study Arms (3)

Group (A) virtual reality group

ACTIVE COMPARATOR

this group will receive virtual reality intervention plus designed physical therapy program

Device: virtual reality

Group (B) mirror therapy group

ACTIVE COMPARATOR

this group will receive mirror therapy intervention plus designed physical therapy program

Other: mirror therapy

Group (C) the compound effect of virtual reality and mirror therapy group

ACTIVE COMPARATOR

this group will receive virtual reality intervention , mirror therapy intervention plus designed physical threrapy program

Other: virtual reality with mirror therapy

Interventions

virtual reality DEVICE

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.

Group (A) virtual reality group

mirror therapy OTHER

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

Group (B) mirror therapy group

virtual reality with mirror therapy OTHER

group C will receive combined effect of both techniques (virtual reality and mirror therapy)

Group (C) the compound effect of virtual reality and mirror therapy group

Eligibility Criteria

• Age: 4 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children will be included in the study if they fulfil the following criteria:
• A medical diagnosis of spastic hemiplegic CP made by pediatric neurologists.
• Children with spasticity grades ranged from 1 to 1+ according to MAS.
• Their age range from 4 to 10 years.
• Children level 1 and level 2 in gross motor functional classification (GMFC 1\&2)

You may not qualify if:

• Children will be excluded from the study if:
• They had a permanent deformity (bony or soft tissue contractures).
• Children having visual or auditory defects.
• Children who can not understand verbal commands
• 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.

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

faculty of physical therapy Kafrelshiekh university

Kafr ash Shaykh, Egypt

Location

Related Publications (1)

• 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.

  PMID: 27705006 BACKGROUND

MeSH Terms

Interventions

Mirror Movement Therapy

Intervention Hierarchy (Ancestors)

Physical Therapy Modalities; Rehabilitation; Therapeutics

Study Officials

• Mohamed B Ibrahim, Ass.Prof.

  head of pediatric department in faculty of physical therapy Kafrelshiekh university

  STUDY CHAIR

• 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

  STUDY DIRECTOR

Central Study Contacts

Khalid E Mohamed, Demonstrator

CONTACT

+201120190879; khalid.esmail@acu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Effect Of Virtual Reality with Mirror Therapy on Upper Limb Functions in Children with Hemiplegic Cerebral Palsy

Study Record Dates

• First Submitted: December 6, 2024
• First Posted: December 11, 2024
• Study Start: December 10, 2024
• Primary Completion: March 10, 2025
• Study Completion: March 15, 2025
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)