Spastic Diplegia Cerebral PalsyNCT04628247
Effect of Spring Gravity Bar on Gait Pattern in Children With Spastic Diplegia
A study testing Spring gravity bar in people with Spastic Diplegia Cerebral Palsy, run by Cairo University at 1 site in Egypt.
Trial summary
The purpose of the study is to determine the effect of spring gravity bar on gait pattern in children with spastic diplegia Read more about this study
- Who is it for?
- Ages 7 to 10 years
- Conditions the study is for
- Spastic Diplegia Cerebral Palsy
- What is being tested?
- Spring gravity bar
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Sep 2020to Dec 2020
- 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 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Their age will be extended from 7 to 10 years.
- They can walk with limitation or holding on according to GMFCS (level II \& II).
- They can understand and follow instruction.
Who cannot join
- 1-children with any visual or auditory abnormalities. 2-children receiving any special medication affecting muscle and /or mental function.
- 3-children had any recent surgical interference in the lower limb. 4-children with perceptual defects. 5-children with fixed structural deformities lower limb.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to determine the effect of spring gravity bar on gait pattern in children with spastic diplegia
Read the detailed description
The purpose of this study is to provide insight on investigate the effectiveness of vestibular stimulation on gait pattern by using spring gravity bar , when you bounce up and down it stimulate vestibular system that is considered straight line vestibular stimulation and strength extensor muscle of lower limb by pressure on spring during stance phase all that change gait stability and stride length so can improve gait pattern .
- Conditions
- Spastic Diplegia Cerebral Palsy
- Being tested
- Spring gravity bar
- Medical subject headings
- Cerebral palsy, spastic, diplegic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spring gravity barDevice
- contain two wooden board length (160 cm) and width (15 cm)
- contain pair of spring at every end of board
- two wooden board connect in the middle
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | They will receive the same traditional physical therapy exercise program in addition to gait training on spring gravity bar for one hour Receives: Device: Spring gravity bar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Two dimensional gait analysis
Two-dimensional (2D) video analysis may provide an accessible and affordable means of quantifying postural control deficits that can be implemented across a spectrum of care settings. Angular joint measures during weight lifting obtained using 2D motion analysis software have been shown to be highly correlated to goniometric measures . This system has also been shown to be reliable in quantifying range of motion during reaching and walking/running tasks
Measured: 20 minute
Dynamic gait index
The Dynamic Gait Index is a sensitive and efficient tool for adults and therefore may be a useful tool for children. Dynamic Gait Index (DGI) is a performance-based tool that quantifiesthe dynamic balance instability developed by Shumway-Cook and Woollacott, evaluates the ability of the individual to modify gait in response to changing functions during walking
Measured: 20 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start21 Sep 2020
- Primary completionNov 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spastic Diplegia 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Baseem Zaki Mahmoud, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04628247
- Sponsor's protocol ID
- P.T.REC/012/002557
- Status last verified
- Nov 2020
- First submitted
- 7 Nov 2020
- Last updated
- 13 Nov 2020
- Results posted
- 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 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Spring Gravity Bar on Gait Pattern in Children With Spastic Diplegia
- ClinicalTrials.gov ID
- NCT04628247
- Acronym / sponsor ID
- P.T.REC/012/002557
- Conditions
- Spastic Diplegia Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 21 Sep 2020 (actual)
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 13 Nov 2020 (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 purpose of the study is to determine the effect of spring gravity bar on gait pattern in children with spastic diplegia
Detailed description
The purpose of this study is to provide insight on investigate the effectiveness of vestibular stimulation on gait pattern by using spring gravity bar , when you bounce up and down it stimulate vestibular system that is considered straight line vestibular stimulation and strength extensor muscle of lower limb by pressure on spring during stance phase all that change gait stability and stride length so can improve gait pattern .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Device: Spring gravity barThey will receive the same traditional physical therapy exercise program in addition to gait training on spring gravity bar for one hour |
Who may qualify
- Ages
- 7 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Their age will be extended from 7 to 10 years.
- They can walk with limitation or holding on according to GMFCS (level II \& II).
- They can understand and follow instruction.
Key exclusion criteria (2 listed)
- 1-children with any visual or auditory abnormalities. 2-children receiving any special medication affecting muscle and /or mental function.
- 3-children had any recent surgical interference in the lower limb. 4-children with perceptual defects. 5-children with fixed structural deformities lower limb.
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 |
|---|---|---|
| Spring gravity bar1. contain two wooden board length (160 cm) and width (15 cm) 2. contain pair of spring at every end of board 3. two wooden board connect in the middle | Device | Study group |
Primary outcome
Two dimensional gait analysis
Time frame: 20 minute
Two-dimensional (2D) video analysis may provide an accessible and affordable means of quantifying postural control deficits that can be implemented across a spectrum of care settings. Angular joint measures during weight lifting obtained using 2D motion analysis software have been shown to be highly correlated to goniometric measures . This system has also been shown to be reliable in quantifying range of motion during reaching and walking/running tasks
Dynamic gait index
Time frame: 20 minute
The Dynamic Gait Index is a sensitive and efficient tool for adults and therefore may be a useful tool for children. Dynamic Gait Index (DGI) is a performance-based tool that quantifiesthe dynamic balance instability developed by Shumway-Cook and Woollacott, evaluates the ability of the individual to modify gait in response to changing functions during walking
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spring gravity bar in people with Spastic Diplegia Cerebral Palsy, run by Cairo University 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 3 inclusion and 2 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 13 Nov 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Baseem Zaki Mahmoud, BSc physiotherapy (002001553896691, baseem2022@googlemail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Two dimensional gait analysis (time frame: 20 minute). 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 13 Nov 2020.