Cerebral PalsyNCT05872217
VIRTUAL REALITY TECHNOLOGY FOR CEREBRAL PALSY
A study testing conventional upper extremity therapeutic program and full immersive VRapeutic software gaming technology in people with Cerebral Palsy, run by Cairo University at 2 sites in Egypt.
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. Read more about this study
- Who is it for?
- Ages 6 to 10 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- conventional upper extremity therapeutic program and full immersive VRapeutic software gaming technology
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 2 sitesEgypt
- Study dates
- Jun 2023to Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- • 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Faculty of Physical Therapy
Giza, 12662
Somaya E Sherif, 01062661942, somaya.sherif@cu.edu.eg
Faculty of Physical Therapy
Giza, 12662
About this study
Official title: 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.
Read the 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
- Being tested
- conventional upper extremity therapeutic program, full immersive VRapeutic software gaming technology
- Keywords
- virtual reality, cerebralpalsy
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional upper extremity therapeutic programOther
- 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 technologyOther
- 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 | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: conventional upper extremity therapeutic program; Other: full immersive VRapeutic software gaming technology |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: period of treatment will be 2 succssive months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study startJun 2023 (estimated)
- Primary completionJan 2024 (estimated)
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Mahmoud Abd-elmonem, Cairo University
- Investigators
- Eman I Elhadidy, Study chair, Cairo UniversityMaya G Abd elwahab, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05872217
- Sponsor's protocol ID
- VRapeutic software
- Status last verified
- May 2023
- First submitted
- 14 May 2023
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VIRTUAL REALITY TECHNOLOGY FOR UPPER EXTREMITY REHABILITATION OF CHILDREN WITH UNILATERAL CEREBRAL PALSY
- ClinicalTrials.gov ID
- NCT05872217
- Acronym / sponsor ID
- VRapeutic software
- Conditions
- Cerebral Palsy
- Keywords
- virtual reality, cerebralpalsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jun 2023 (estimated)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 24 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| control group | Placebo comparator | 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 * 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 | Experimental | Other: conventional upper extremity therapeutic program, Other: full immersive VRapeutic software gaming technologyChildren 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 |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- • Their ages will range from of 6 to 10 years.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | control group, study group |
| 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 | Other | study group |
Primary outcome
rang of motion
Time frame: period of treatment will be 2 succssive months
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
Time frame: period of treatment will be 2 succssive months
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eman I Elhadidy study chair
Cairo University
Maya G Abd elwahab study director
Cairo University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional upper extremity therapeutic program and full immersive VRapeutic software gaming technology in people with Cerebral Palsy, run by Cairo University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Somaya E Sherif (01062661942, somaya.sherif@cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rang of motion (time frame: period of treatment will be 2 succssive months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2023.