Clinical trial NCT05872217: VIRTUAL REALITY TECHNOLOGY FOR CEREBRAL PALSY
Official title: VIRTUAL REALITY TECHNOLOGY FOR UPPER EXTREMITY REHABILITATION OF CHILDREN WITH UNILATERAL CEREBRAL PALSY
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebral Palsy
Keywords: virtual reality
cerebralpalsy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-05-24
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: intervention Control Group: Children in this group will receive conventional UE therapeutic program for about 60 minutes/3session per week.

Children in this group will receive the same conventional UE therapeutic program as control group in addition to virtual reality session using fully-immersive VRapeutic software gaming technology (Archeeko module) for 30 min/3sessions/week for 8 weeks.
Primary purpose: TREATMENT

Brief summary: The VRapeutic (Full-immersive game-based therapy) is new therapeutic Egyptian software. It has the potential to provide intensive, repetitive, and task-oriented training. It may increase children's motivation, enjoyment, active social participation. Children with UCP may experience varieties of associated health conditions as difficulty of movement, instability of postural balance, difficulty of motor planning and control which impact on UE function.

Detailed description: Ethical statement this study was approved by institutional Review Board of the faculty of physical therapy ,cairo university .Egypt (no.P.T.REC/012/004237) .

Study Design A prospective randomized controlled trial of pre-post study design with two months follow-up evaluation will be used.

Sample size estimation

will be conducted to determine the number of recruited children. G\*POWER statistical software (version 3.1.9.2) will be used using α=0.05, power 80% allocation ratio N2/N1 =1.

Randomization The selected children will be assigned by simple randomization via closed envelopes into two equal groups (control and study); the envelope will be contained a letter indicating whether the child will be assigned to the control or to the study group.

Eligibility criteria: Inclusion Criteria:

* • Their ages will range from of 6 to 10 years.

  * Both genders will be included.
  * Their degree of spasticity will range from 1 to 1+ according to the Modified Ashworth Scale (Meseguer et al., 2018).
  * Their motor function will be at level I according to Gross Motor Function Classification System (Palisano et al., 2008).
  * They will be able to understand and follow the instructions.

Exclusion Criteria:

* Exclusion Criteria:

Children will be excluded from the study if they have any of the following criteria:

* Epilepsy.
* Visual or hearing problems.
* Musculoskeletal fixed deformity in upper limbs, lower limbs or spine.
* Orthopedic surgery on the involved UE.
* Botulinum toxin therapy for the affected UE within the past 6 months or within the study period.

Primary outcomes:
measure: rang of motion
timeFrame: period of treatment will be 2 succssive months
measure: • ABILHAND-Kids questionnaire
timeFrame: period of treatment will be 2 succssive months
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Physical Therapy
city: Giza
country: Egypt
facility: Faculty of Physical Therapy
Study officials:
affiliation: Cairo University
name: Eman I Elhadidy
role: STUDY_CHAIR
affiliation: Cairo University
name: Maya G Abd elwahab
role: STUDY_DIRECTOR
References: