Ataxic Cerebral PalsyNCT05411328
Efficacy of Virtual Reality on Balance in Children With Ataxic Cerebral Palsy Randomized Controlled Trail
A study testing virtual reality in people with Ataxic Cerebral Palsy, run by Delta University for Science and Technology at 1 site in Egypt.
Trial summary
Ataxic CP is one type of cerebral palsy. children with ataxic cerebral palsy have trouble with balance and coordination. They may walk with their legs farther apart than other kids and have a hard time with activities that use small hand movements, like writing. Read more about this study
- Who is it for?
- Ages 9 to 14 years
- Conditions the study is for
- Ataxic Cerebral Palsy
- What is being tested?
- virtual reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2022to 30 Apr 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 9 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ataxic cerebral palsy aged 9-14 years
Who cannot join
- any musculoskeletal conditions that affect balance previous surgeries that affecting balance
Trial locations and contacts
1 site in 1 country.
About this study
Ataxic CP is one type of cerebral palsy. children with ataxic cerebral palsy have trouble with balance and coordination. They may walk with their legs farther apart than other kids and have a hard time with activities that use small hand movements, like writing. Some also have trouble with depth perception This means being able to accurately judge how close or far away something is
- Conditions
- Ataxic Cerebral Palsy
- Being tested
- virtual reality
- Medical subject headings
- Cerebral Palsy, Ataxic, Autosomal Recessive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual realityDevice
All children in the two groups received physical therapy protocol for 30 minutes in addition to virtual reality game traditional physical therapy group traditional physical therapy group
| Study group | Role | What they receive |
|---|---|---|
| traditional physical therapy group | Experimental | received traditional physical therapy protocol Receives: Device: virtual reality |
| virtual reality group | Experimental | received the same traditional physical therapy in addition to virtual reality games Receives: Device: virtual reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in overall stability index
change in overall stability index will measured by using biodex balance system
Measured: [Time Frame: baseline and after 3 months of intervention.]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start1 Nov 2022
- Primary completion15 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ataxic 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
- Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Delta University for Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, walaa eldesoukey heneidy, Delta University for Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05411328
- Sponsor's protocol ID
- virtual reality and ataxic cp
- Status last verified
- Aug 2024
- First submitted
- 6 Jun 2022
- Last updated
- 6 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Virtual Reality on Balance in Children With Ataxic Cerebral Palsy Randomized Controlled Trail
- ClinicalTrials.gov ID
- NCT05411328
- Acronym / sponsor ID
- virtual reality and ataxic cp
- Conditions
- Ataxic Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Delta University for Science and TechnologyUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 9 Jun 2022 (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.
Ataxic CP is one type of cerebral palsy. children with ataxic cerebral palsy have trouble with balance and coordination. They may walk with their legs farther apart than other kids and have a hard time with activities that use small hand movements, like writing. Some also have trouble with depth perception This means being able to accurately judge how close or far away something is
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| traditional physical therapy group | Experimental | Device: virtual realityreceived traditional physical therapy protocol |
| virtual reality group | Experimental | Device: virtual realityreceived the same traditional physical therapy in addition to virtual reality games |
Who may qualify
- Ages
- 9 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- ataxic cerebral palsy aged 9-14 years
Key exclusion criteria (1 listed)
- any musculoskeletal conditions that affect balance previous surgeries that affecting balance
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 realityAll children in the two groups received physical therapy protocol for 30 minutes in addition to virtual reality game traditional physical therapy group traditional physical therapy group | Device | traditional physical therapy group, virtual reality group |
Primary outcome
Change in overall stability index
Time frame: [Time Frame: baseline and after 3 months of intervention.]
change in overall stability index will measured by using biodex balance system
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 6 Aug 2024.
- Individual participant dataSharing planned: Yes
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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 in people with Ataxic Cerebral Palsy, run by Delta University for Science and Technology 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 1 inclusion and 1 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 6 Aug 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?
Change in overall stability index (time frame: [Time Frame: baseline and after 3 months of intervention.]). 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 6 Aug 2024.