Cerebral PalsyNCT05740020
Effect of Virtual Reality in Spider Cage on Gross Motor Performance and Balance in Children With Spastic Diplegia
A study testing virtual reality glasses and The traditional exercise program in people with Cerebral Palsy, run by Amr Mohsen Mohamed Abo Khatwa at 1 site in Egypt.
Trial summary
This study will detect the effect of virtual reality in spider cage on gross motor performance and balance in children with spastic diplegia. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- virtual reality glasses and The traditional exercise program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2023to 1 Jul 2023
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children will be included in the study if they fulfil the following criteria:
- A medical diagnosis of spastic diplegic CP made by pediatricians or pediatric neurologists.
- Children with spasticity grades ranged from 1 to 2+ according to Modified Ashworth scale (MAS).
- Their age range from 6 to 12 years.
- Children who can sit on the chair with good balance and recognize and follow verbal orders and commands included in both testing and training techniques.
Who cannot join
- Children with a permanent spastic diplegia, who might have one or more of the following, will be excluded:
- They had a permanent deformity (bony or soft tissue contractures).
- Children having visual or auditory defects.
- Current hospitalization for urgent medical reasons.
- Severe mental retardation.
- Children who will undergo fewer than twelve regular sessions of physical therapy at their place will not be included in the survey.
- Children with history of epileptic seizure or any diagnosed cardiac or orthopedic disability that may hinder assessment methods and treatment.
Trial locations and contacts
1 site in 1 country.
About this study
This study will detect the effect of virtual reality in spider cage on gross motor performance and balance in children with spastic diplegia.
Read the detailed description
The current study will be directed to investigate effect of virtual reality on gross motor and balance as the weakness of the trunk muscles and lower limb muscles along with spasticity potentially predispose balance and walking issues of children with bilateral spastic CP .
The balance deficits in children with CP are multifactorial. According to the system's model proposed by Woollacott and Shumway-Cook, multiple systems contribute to postural dysfunction in children with CP. Muscle weakness and stiffness of lower limb muscles account for biomechanical constraints and postural malalignment during standing and functional balancing.
Virtual reality is one of the novel technology-based approaches to treat balance and motor function in children with CP. It utilizes the interactive simulations created in computer hardware and software, in which the children find opportunities to engage in environments appearing real to them .
After reviewing the available previous published studies, it was found that there is no previous study directly compared between the effects of virtual reality and physical therapy in spider cage on gross motor performance and balance with diplegic children CP children. Both therapeutic modalities were found to induce good clinical outcomes when studied separately, so this study will be conducted to examine the effectiveness of virtual reality.
The greater demand for physical therapy for Paediatrics' signifies the need for more effective, safer and evident therapeutic modalities. The findings of this study will help both; the therapists and the children to save time, effort and reach the best results in concise times.
- Conditions
- Cerebral Palsy
- Being tested
- virtual reality glasses, The traditional exercise program
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual reality glassesDevice
A specialized VR glasses will be used and VR games application in spider cage
The traditional exercise programOther
The selected physical therapy program:
- Neurodevelopmental approach: aims to facilitate typical motor development and function and to prevent secondary impairments (figure 4).
- Approximation: aims to control spasticity and stimulate the joint mechanoreceptors (figure 5).
- Stretching exercise: aims to maintain length and flexibility of shorten muscles (figure 6).
- Strengthening exercise: aims to improve the functional ability (figure 7).
- Spider suspension exercise for 30 minutes (figure 8).
- Gait training activities: aims to improve balance (figure 9). 6. Balance training program: aims to improve balance (figure 10).
| Study group | Role | What they receive |
|---|---|---|
| Group (A) | Experimental | Group (A) will receive virtual reality in addition to the traditional exercise program. Receives: Device: virtual reality glasses; Other: The traditional exercise program |
| Group (B) | Active comparator | Group (B) will receive traditional exercise program. Receives: Other: The traditional exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
GROSS MOTOR PERFORMANCE
we will use Gross Motor Function Measure 88 (GMFM-88) to measure Gross motor performance.
this score range from (0 to 100 ) zero is the minimum value and 100 is the maximum value
Measured: 3 monthes
BALANCE
we will use Pediatric Balance Scale (PBS) to measure Balance. this score range from (0 to 56 ) zero is the minimum value and 56 is the maximum value
Measured: 3 monthes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2023
- Study start1 Apr 2023
- Primary completion1 Jul 2023
- Study completion1 Jul 2023
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.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amr Mohsen Mohamed Abo Khatwa
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Amr Mohsen Mohamed Abo Khatwa, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05740020
- Sponsor's protocol ID
- EG, KFS lab Research 1
- Status last verified
- Jan 2024
- First submitted
- 13 Feb 2023
- Last updated
- 18 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Virtual Reality in Spider Cage on Gross Motor Performance and Balance in Children With Spastic Diplegia
- ClinicalTrials.gov ID
- NCT05740020
- Acronym / sponsor ID
- EG, KFS lab Research 1
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Amr Mohsen Mohamed Abo KhatwaUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 22 Feb 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.
This study will detect the effect of virtual reality in spider cage on gross motor performance and balance in children with spastic diplegia.
Detailed description
The current study will be directed to investigate effect of virtual reality on gross motor and balance as the weakness of the trunk muscles and lower limb muscles along with spasticity potentially predispose balance and walking issues of children with bilateral spastic CP .
The balance deficits in children with CP are multifactorial. According to the system's model proposed by Woollacott and Shumway-Cook, multiple systems contribute to postural dysfunction in children with CP. Muscle weakness and stiffness of lower limb muscles account for biomechanical constraints and postural malalignment during standing and functional balancing.
Virtual reality is one of the novel technology-based approaches to treat balance and motor function in children with CP. It utilizes the interactive simulations created in computer hardware and software, in which the children find opportunities to engage in environments appearing real to them .
After reviewing the available previous published studies, it was found that there is no previous study directly compared between the effects of virtual reality and physical therapy in spider cage on gross motor performance and balance with diplegic children CP children. Both therapeutic modalities were found to induce good clinical outcomes when studied separately, so this study will be conducted to examine the effectiveness of virtual reality.
The greater demand for physical therapy for Paediatrics' signifies the need for more effective, safer and evident therapeutic modalities. The findings of this study will help both; the therapists and the children to save time, effort and reach the best results in concise times.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group (A) | Experimental | Device: virtual reality glasses, Other: The traditional exercise programGroup (A) will receive virtual reality in addition to the traditional exercise program. |
| Group (B) | Active comparator | Other: The traditional exercise programGroup (B) will receive traditional exercise program. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children will be included in the study if they fulfil the following criteria:
Key exclusion criteria (7 listed)
- Children with a permanent spastic diplegia, who might have one or more of the following, will be excluded:
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 |
|---|---|---|
| virtual reality glassesA specialized VR glasses will be used and VR games application in spider cage | Device | Group (A) |
| The traditional exercise programThe selected physical therapy program: 1. Neurodevelopmental approach: aims to facilitate typical motor development and function and to prevent secondary impairments (figure 4). 2. Approximation: aims to control spasticity and stimulate the joint mechanoreceptors (figure 5). 3. Stretching exercise: aims to maintain length and flexibility of shorten muscles (figure 6). 4. Strengthening exercise: aims to improve the functional ability (figure 7). 5. Spider suspension exercise for 30 minutes (figure 8). 5. Gait training activities: aims to improve balance (figure 9). 6. Balance training program: aims to improve balance (figure 10). | Other | Group (A), Group (B) |
Primary outcome
GROSS MOTOR PERFORMANCE
Time frame: 3 monthes
we will use Gross Motor Function Measure 88 (GMFM-88) to measure Gross motor performance. this score range from (0 to 100 ) zero is the minimum value and 100 is the maximum value
BALANCE
Time frame: 3 monthes
we will use Pediatric Balance Scale (PBS) to measure Balance. this score range from (0 to 56 ) zero is the minimum value and 56 is the maximum value
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing virtual reality glasses and The traditional exercise program in people with Cerebral Palsy, run by Amr Mohsen Mohamed Abo Khatwa at 1 site 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 7 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: finished, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GROSS MOTOR PERFORMANCE (time frame: 3 monthes). 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 18 Jan 2024.