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Not yet recruiting NCT06728475

Virtual Reality With Mirror Therapy on Upper Limb Function

No phase Interventional Hemiplegic Cerebral Palsy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: virtual reality, mirror therapy, virtual reality with mirror therapy.
Who it may be relevant to
Registry conditions: Hemiplegic Cerebral Palsy. Basic parameters: 4 years — 10 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

Interventions

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

Primary outcome measures

  • changes in upper limb functions [Time frame: after 12 weeks of intervention]
  • changes in power grip strength [Time frame: after 12 weeks of intervention]
  • changes in range of motion (ROM) [Time frame: after 12 weeks of intervention]
Secondary outcome measures (1)
  • changes in activity of daily living (ADL) [Time frame: after 12 weeks of intervention]

Eligibility criteria

Inclusion criteria

  • 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)

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Other

Study locations

Egypt · 1 center
  • faculty of physical therapy Kafrelshiekh university — Kafr ash Shaykh

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. PMID 27705006

Identifiers

NCT: NCT06728475 · KFSIRB200-254

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗