VIRTUAL REALITY TECHNOLOGY FOR CEREBRAL PALSY

NCT ID: NCT05872217

Last Updated: 2023-05-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-30
• Study Completion Date: 2024-02-29

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.

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.

Conditions

Cerebral Palsy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

conventional upper extremity therapeutic program

Intervention Type: 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.

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

Group Type: EXPERIMENTAL

conventional upper extremity therapeutic program

Intervention Type: 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.

full immersive VRapeutic software gaming technology

Intervention Type: 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

Interventions

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.

Intervention Type: 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

Intervention Type: OTHER

Eligibility 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

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Amira Mahmoud Abd-elmonem

principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eman I Elhadidy

Role: STUDY_CHAIR

Cairo University

Maya G Abd elwahab

Role: STUDY_DIRECTOR

Cairo University

Locations

Faculty of Physical Therapy

Giza, , Egypt

Faculty of Physical Therapy

Giza, , Egypt

Countries

Egypt

Central Contacts

Somaya E Sherif

Role: CONTACT

somaya.sherif@cu.edu.eg

01062661942

Facility Contacts

Somaya E Sherif

Role: primary

somaya.sherif@cu.edu.eg

01062661942

Other Identifiers

VRapeutic software

Identifier Type: -

Identifier Source: org_study_id