VIRTUAL REALITY TECHNOLOGY FOR CEREBRAL PALSY

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05872217
• Other study ID #: VRapeutic software
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2023
• Est. completion date: February 2024

Study information

• Verified date: May 2023
• Source: Cairo University
• Contact: Somaya E Sherif
• Phone: 01062661942
• Email: somaya.sherif[@]cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: February 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 10 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

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.
• 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

Locations

Country	Name	City	State
Egypt	Faculty of Physical Therapy	Giza
Egypt	Faculty of Physical Therapy	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	• 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