VIRTUAL REALITY TECHNOLOGY FOR CEREBRAL PALSY

VIRTUAL REALITY TECHNOLOGY FOR UPPER EXTREMITY REHABILITATION OF CHILDREN WITH UNILATERAL CEREBRAL PALSY

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cerebral Palsy
• Intervention / Treatment: Other: conventional upper extremity therapeutic program; Other: full immersive VRapeutic software gaming technology

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
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Somaya E Sherif; Phone Number: 01062661942; Email: somaya.sherif@cu.edu.eg

Study Locations

• Egypt
  • Giza, Egypt, 12662
    • Faculty of Physical Therapy
    • Contact: Somaya E Sherif; Phone Number: 01062661942; Email: somaya.sherif@cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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; • This group will receive conventional UE therapeutic program for 60 minutes each session including: Exercises based on neurodevelopment technique .; Gentle manual stretching for tight muscles of the affected UE from proximal to distal segments for 5minutes.; 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.
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; • This group will receive conventional UE therapeutic program for 60 minutes each session including: Exercises based on neurodevelopment technique .; Gentle manual stretching for tight muscles of the affected UE from proximal to distal segments for 5minutes.; 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: full immersive VRapeutic software gaming technology; • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rang of motion	The IMU sensors will be used to detect changes in angular displacement of child arm, forearm (which allow 3D analysis of movements in three planes X.Y.Z), speed and direction. Placement of Sensors: Two sensors will be placed on the affected side, one around the arm distal to shoulder joint and the other around the forearm distal to elbow joint. The third sensor will be placed around the trunk. The child will be in standing position with head in neutral position, trunk erect. The examiner will ask the child to perform functional task in form of (reaching forward toward targets placed on wall in multilevel, hand over head).	period of treatment will be 2 succssive months
• ABILHAND-Kids questionnaire	will be administrated on an interview basis, the child will be asked to estimate their perception of the level of difficulty that faces during the performance of each activity in the list on a three-point ordinal scale of impossible, difficult, easy. Activities will be presented in random order to avoid any systematic effect. Activities not attempted in the last 3 months are not scored and are entered as missing responses (tick the question mark).	period of treatment will be 2 succssive months

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Chair: Eman I Elhadidy, Cairo University; Study Director: Maya G Abd elwahab, Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2023
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): February 1, 2024

Study Registration Dates

• First Submitted: May 14, 2023
• First Submitted That Met QC Criteria: May 14, 2023
• First Posted (Actual): May 24, 2023

Study Record Updates

• Last Update Posted (Actual): May 24, 2023
• Last Update Submitted That Met QC Criteria: May 14, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: virtual reality; cerebralpalsy
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: VRapeutic software

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No