Clinical trial NCT06728475: Virtual Reality With Mirror Therapy on Upper Limb Function
Official title: Effect Of Virtual Reality With Mirror Therapy on Upper Limb Functions in Children With Hemiplegic Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hemiplegic Cerebral Palsy
Keywords: Hemiplagia
Upper limb function
Virtual reality
Mirror therapy
Xbox 360
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2024-12-11
Enrollment: 60
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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

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

Eligibility criteria: 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.

Primary outcomes:
measure: changes in upper limb functions
timeFrame: after 12 weeks of intervention
measure: changes in power grip strength
timeFrame: after 12 weeks of intervention
measure: changes in range of motion (ROM)
timeFrame: after 12 weeks of intervention
Secondary outcomes:
measure: changes in activity of daily living (ADL)
timeFrame: after 12 weeks of intervention
Other outcomes:
Locations:
city: Kafr Ash Shaykh
country: Egypt
facility: faculty of physical therapy Kafrelshiekh university
Study officials:
affiliation: head of pediatric department in faculty of physical therapy Kafrelshiekh university
name: Mohamed B Ibrahim, Ass.Prof.
role: STUDY_CHAIR
affiliation: Professor and head of department of pediatric department Faculty of medicine Kafrelshiekh university
name: Osama A El-Agamy, Professor
role: STUDY_DIRECTOR
affiliation: Lecturer in pediatric department in faculty of physical therapy Kafrelshiekh University
name: Sara Y Abdel Elglil, Lecturer
role: STUDY_DIRECTOR
References:
citation: 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.