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NCT05872217 | Not yet recruiting | Cerebral Palsy


VIRTUAL REALITY TECHNOLOGY FOR CEREBRAL PALSY
Sponsor:

Cairo University

Information provided by (Responsible Party):

Amira Mahmoud Abdalmanam

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.

Condition or disease

Cerebral Palsy

Intervention/treatment

conventional upper extremity therapeutic program

full immersive VRapeutic software gaming technology

Phase

Not Applicable

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.}}

Study Type : Interventional
Estimated Enrollment : 30 participants
Masking : Triple
Masking Description : A prospective randomized controlled trial of pre-post study design with two months follow-up evaluation will be used.
Primary Purpose : Treatment
Official Title : VIRTUAL REALITY TECHNOLOGY FOR UPPER EXTREMITY REHABILITATION OF CHILDREN WITH UNILATERAL CEREBRAL PALSY
Actual Study Start Date : June 2023
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : February 2024
Arm Intervention/treatment

Placebo Comparator: control group

• 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.

Other: conventional upper extremity therapeutic program

Experimental: study group

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

Other: conventional upper extremity therapeutic program

Ages Eligible for Study: 6 Years to 10 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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.

    VIRTUAL REALITY TECHNOLOGY FOR CEREBRAL PALSY

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    VIRTUAL REALITY TECHNOLOGY FOR CEREBRAL PALSY

    How to Participate

    Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

    Locations


    Not yet recruiting

    Egypt,

    Faculty of Physical Therapy

    Giza, Egypt, 12662

    Not yet recruiting

    Egypt,

    Faculty of Physical Therapy

    Giza, Egypt, 12662

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