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VIRTUAL REALITY TECHNOLOGY FOR CEREBRAL PALSY

Primary Purpose

Cerebral Palsy

Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
conventional upper extremity therapeutic program
full immersive VRapeutic software gaming technology
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring virtual reality, cerebralpalsy

Eligibility Criteria

6 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty of Physical Therapy
  • Faculty of Physical Therapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

control group

study group

Arm Description

• 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.

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

Outcomes

Primary Outcome Measures

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).
• 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).

Secondary Outcome Measures

Full Information

First Posted
May 14, 2023
Last Updated
May 14, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05872217
Brief Title
VIRTUAL REALITY TECHNOLOGY FOR CEREBRAL PALSY
Official Title
VIRTUAL REALITY TECHNOLOGY FOR UPPER EXTREMITY REHABILITATION OF CHILDREN WITH UNILATERAL CEREBRAL PALSY
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2023 (Anticipated)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
virtual reality, cerebralpalsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
A prospective randomized controlled trial of pre-post study design with two months follow-up evaluation will be used.
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
• 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.
Arm Title
study group
Arm Type
Experimental
Arm Description
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
Intervention Name(s)
conventional upper extremity therapeutic program
Intervention Description
• 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
Intervention Name(s)
full immersive VRapeutic software gaming technology
Intervention Description
• 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
Primary Outcome Measure Information:
Title
rang of motion
Description
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).
Time Frame
period of treatment will be 2 succssive months
Title
• ABILHAND-Kids questionnaire
Description
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).
Time Frame
period of treatment will be 2 succssive months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
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: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Somaya E Sherif
Phone
01062661942
Email
somaya.sherif@cu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eman I Elhadidy
Organizational Affiliation
Cairo University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Maya G Abd elwahab
Organizational Affiliation
Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Physical Therapy
City
Giza
ZIP/Postal Code
12662
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Somaya E Sherif
Phone
01062661942
Email
somaya.sherif@cu.edu.eg
Facility Name
Faculty of Physical Therapy
City
Giza
ZIP/Postal Code
12662
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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VIRTUAL REALITY TECHNOLOGY FOR CEREBRAL PALSY

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