VIRTUAL REALITY TECHNOLOGY FOR CEREBRAL PALSY

NCT05872217 | Unknown DMC

• 1 other identifier: VRapeutic software
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Cerebral Palsy

Keywords

virtual reality; cerebralpalsy

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

control group

PLACEBO COMPARATOR

• 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

study group

EXPERIMENTAL

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; Other: full immersive VRapeutic software gaming technology

Interventions

conventional upper extremity therapeutic program OTHER

• 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.

control group; study group

full immersive VRapeutic software gaming technology OTHER

• 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

study group

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (2)

Faculty of Physical Therapy

Giza, 12662, Egypt

Location

Faculty of Physical Therapy

Giza, 12662, Egypt

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Eman I Elhadidy

  Cairo University

  STUDY CHAIR

• Maya G Abd elwahab

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Somaya E Sherif

CONTACT

01062661942; somaya.sherif@cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: A prospective randomized controlled trial of pre-post study design with two months follow-up evaluation will be used.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Model Details: 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.

Study Record Dates

• First Submitted: May 14, 2023
• First Posted: May 24, 2023
• Study Start: June 1, 2023
• Primary Completion: January 1, 2024
• Study Completion: February 1, 2024
• Last Updated: May 24, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)