Balance Problems in Spastic Hemiplegic ChildrenNCT05463718
Virtual Reality Versus Balance Beam on Spastic Hemiplegic Cerebral Palsy
A study testing Virtual Reality in people with Balance Problems in Spastic Hemiplegic Children and Walking Performance in Spastic Hemiplegic Children, run by Cairo University at 2 sites in Egypt.
Trial summary
Is there any difference between the use of Virtual reality and Balance beam on walking performance in children with Spastic Hemiplegic Children? Read more about this study
- Who is it for?
- Ages 7 to 11 years
- Conditions the study is for
- Balance Problems in Spastic Hemiplegic Children, Walking Performance in Spastic Hemiplegic Children
- 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
- 75 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Aug 2022to 1 Dec 2022
- 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 7 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age ranges from 7 to 11 years old, from both genders.
- Modified Ashworth scale adopted from, (Bohannon and Smith,1987) was used to select the patients with grade 1 and 1+ of Spasticity.
- They were able to stand and walk.
- Gross motor function measure scale GMFM (level I \&II). (Russell et al. ,2013).
- Children with good mentality to understand the evaluation steps.
Who cannot join
- Children who have orthopedic surgery or Botulinum Toxin-A injection in the last 6 months.
- Children who have any spinal deformities.
- Children with severe muscle contracture.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Not yet recruiting
Physical Therapy
Cairo
- Recruiting
Physical Therapy
Cairo
physical therapy, doctoral, 02 37617691, un.grad@pt.cu.edu.eg
About this study
Official title: Virtual Reality Versus Balance Beam on Walking Performance in Children With Spastic Hemiplegic Cerebral Palsy
Is there any difference between the use of Virtual reality and Balance beam on walking performance in children with Spastic Hemiplegic Children?
Read the detailed description
To compare the effect of Virtual reality and the traditional physical therapy program based on Neurodevelopmental technique with Spastic Hemiplegic Children.
To compare the effect of Balance beam and the traditional physical therapy program based on Neurodevelopmental technique with Spastic Hemiplegic Children.
To compare the effect of Virtual reality and Balance beam on walking performance in children with Spastic Hemiplegic Children.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityDevice
children treated by Virtual Reality for 15 min. besides the traditional physical therapy program
| Study group | Role | What they receive |
|---|---|---|
| children treated by the traditional physical therapy program based on Neurodevelopmental technique | Experimental | Twenty-five cerebral palsied hemiplegic children will be treated by the traditional physical therapy program ( balance board, single limb support, standing with throwing ball ) based on Neurodevelopmental technique for 6 month Receives: Device: Virtual Reality |
| children treated by Virtual Reality for 15 min. besides the traditional physical therapy program | Experimental | twenty-five cerebral palsied hemiplegics will be included in this group; they will be receive the regular physical therapy program in addition to training by Virtual reality with use of the HMD helmet allows users to perceive a 3D stereoscopic images that enable participants to interact with different balance games as football Soccer, football heading (known as Soccer Heading), the tight rope walks and the Penguin slide game. Receives: Device: Virtual Reality |
| children treated by Balance Beam for 15 min besides the traditional physical therapy program | Experimental | Twenty-five cerebral palsied hemiplegics will be included in this group; they will be receive the regular physical therapy program in addition to training by standing and walking in balance beam by differentiate levels of walking balance proficiency as varying widths of beam and walking in different direction (forward or backward). Receives: Device: Virtual Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance it will be assist by HUMAC Balance Assessment system
Evaluation materials that used in assist balance :
HUMAC Balance Assessment system consists of:
1- The force platform 2- The HUMAC CD holding the operating program This test will be use assess the sensory integration of balance and postural control in the conditions of eyes open and eyes closed from standing, lasts for 30 second and the test was repeated for three times and the mean value is calculated from the result of each trial which appears in the form of percent of stability in each trial
Measured: 6 month
Walking ability
Evaluation materials
Six Minute Walk Test (6MWT) it is a valid and reliable instrumentation using to asses walking capacity The child of this test is to walk as far as possible for 6 minutes. You will walk back and forth in this hallway, after the test, measured walking capacity exercise (BP, HR and SpO2) were re-measured.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2022
- Study start1 Aug 2022 (estimated)
- Primary completion1 Nov 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Balance Problems in Spastic Hemiplegic ChildrenStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohanad Mohsen Madboly Elsayed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05463718
- Sponsor's protocol ID
- 012/003683
- Status last verified
- Jan 2022
- First submitted
- 19 Jun 2022
- Last updated
- 19 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Versus Balance Beam on Walking Performance in Children With Spastic Hemiplegic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05463718
- Acronym / sponsor ID
- 012/003683
- Conditions
- Balance Problems in Spastic Hemiplegic Children, Walking Performance in Spastic Hemiplegic Children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (estimated)
- Primary completion
- 1 Nov 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 19 Jul 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.
Is there any difference between the use of Virtual reality and Balance beam on walking performance in children with Spastic Hemiplegic Children?
Detailed description
To compare the effect of Virtual reality and the traditional physical therapy program based on Neurodevelopmental technique with Spastic Hemiplegic Children.
To compare the effect of Balance beam and the traditional physical therapy program based on Neurodevelopmental technique with Spastic Hemiplegic Children.
To compare the effect of Virtual reality and Balance beam on walking performance in children with Spastic Hemiplegic Children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| children treated by the traditional physical therapy program based on Neurodevelopmental technique | Experimental | Device: Virtual RealityTwenty-five cerebral palsied hemiplegic children will be treated by the traditional physical therapy program ( balance board, single limb support, standing with throwing ball ) based on Neurodevelopmental technique for 6 month |
| children treated by Virtual Reality for 15 min. besides the traditional physical therapy program | Experimental | Device: Virtual Realitytwenty-five cerebral palsied hemiplegics will be included in this group; they will be receive the regular physical therapy program in addition to training by Virtual reality with use of the HMD helmet allows users to perceive a 3D stereoscopic images that enable participants to interact with different balance games as football Soccer, football heading (known as Soccer Heading), the tight rope walks and the Penguin slide game. |
| children treated by Balance Beam for 15 min besides the traditional physical therapy program | Experimental | Device: Virtual RealityTwenty-five cerebral palsied hemiplegics will be included in this group; they will be receive the regular physical therapy program in addition to training by standing and walking in balance beam by differentiate levels of walking balance proficiency as varying widths of beam and walking in different direction (forward or backward). |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age ranges from 7 to 11 years old, from both genders.
- Modified Ashworth scale adopted from, (Bohannon and Smith,1987) was used to select the patients with grade 1 and 1+ of Spasticity.
- They were able to stand and walk.
- Gross motor function measure scale GMFM (level I \&II). (Russell et al. ,2013).
- Children with good mentality to understand the evaluation steps.
Key exclusion criteria (3 listed)
- Children who have orthopedic surgery or Botulinum Toxin-A injection in the last 6 months.
- Children who have any spinal deformities.
- Children with severe muscle contracture.
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 Realitychildren treated by Virtual Reality for 15 min. besides the traditional physical therapy program | Device | children treated by Balance Beam for 15 min besides the traditional physical therapy program, children treated by Virtual Reality for 15 min. besides the traditional physical therapy program, children treated by the traditional physical therapy program based on Neurodevelopmental technique |
Primary outcome
Balance it will be assist by HUMAC Balance Assessment system
Time frame: 6 month
Evaluation materials that used in assist balance : HUMAC Balance Assessment system consists of: 1- The force platform 2- The HUMAC CD holding the operating program This test will be use assess the sensory integration of balance and postural control in the conditions of eyes open and eyes closed from standing, lasts for 30 second and the test was repeated for three times and the mean value is calculated from the result of each trial which appears in the form of percent of stability in each trial
Walking ability
Time frame: 6 month
Evaluation materials Six Minute Walk Test (6MWT) it is a valid and reliable instrumentation using to asses walking capacity The child of this test is to walk as far as possible for 6 minutes. You will walk back and forth in this hallway, after the test, measured walking capacity exercise (BP, HR and SpO2) were re-measured.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2022.
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Neurodevelopmental Disorders, Neurodevelopmental Disorders (NDD)
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.
2 sites 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 Balance Problems in Spastic Hemiplegic Children and Walking Performance in Spastic Hemiplegic Children, 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 3 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 19 Jul 2022. 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. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance it will be assist by HUMAC Balance Assessment system (time frame: 6 month). 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 19 Jul 2022.