VIRTUAL REALITY TECHNOLOGY FOR CEREBRAL PALSY

Cairo University (CU)

Status: Not yet enrolling

Conditions: Cerebral Palsy

Treatments: Other: full immersive VRapeutic software gaming technology; Other: conventional upper extremity therapeutic program

Study type: Interventional

Funder types: Other

Identifiers

NCT05872217

VRapeutic software

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 6 to 10 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups, including a placebo group

control group

Placebo Comparator group

Description:

• This group will receive conventional UE therapeutic program for 60 minutes each session including: * Exercises based on neurodevelopment technique . * Gentle manual stretching * Weight-bearing exercises for 10minutes for UE from prone lying, side sitting and quadriped position . * Strengthening exercises for 10 minutes for muscles of UE as push-up from prone lying position, quadriped position, 3 point exercise, walk on hand, climbing, hanging on a bar, squeeze stress balls, cutting usescissors to strengthen hand . * Goal directed training for 10 minutes the child will practice specific tasks that are needed for everyday life and which they find a challenge like (3 daily tasks as cleaning mirror, dressing and undressing, using pen and ruler to draw shapes, brushing teeth . * Fine motor activities as reach, grasp, carry and release activities.

Treatment:

Other: conventional upper extremity therapeutic program

study group

Experimental group

Description:

Children in this group will receive the same conventional UE therapeutic program as control group for 60 minutes in addition to virtual reality session using VRapeutic software gaming technology, Archeeko module (figure 3) for 30 min/3 sessions/week for 8 weeks

Treatment:

Other: full immersive VRapeutic software gaming technology

Other: conventional upper extremity therapeutic program