Cerebral PalsyNCT05014451
Pelvic Alignment in Relation to Standing Balance and Selective Motor Control in Children With Spastic Diplegia
An observational study of Cerebral Palsy and Spastic Diplegia, run by Cairo University.
Trial summary
This study will be conducted to identify the relation between pelvic alignment and standing balance and also the relation between pelvic alignment and selective motor control in children with spastic diplegic cerebral palsy. Read more about this study
- Who is it for?
- Ages 6 to 8 years
- Conditions the study is for
- Cerebral Palsy, Spastic Diplegia
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2021to 30 Dec 2021
- Phase
- Observational
- 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 8 years
- All sexes
- No healthy volunteers
- Child
Study population: Children with spastic diplegia, their height will not be less than 1 meter to meet the requirements of assessment by the Biodex and Formetric systems. They will be able to stand without the use of an assistive device and they will be able to follow instructions and understand given orders.
Who may be able to join
- Their age will be ranged from 6 to 8 years.
- The degree of their spasticity will be ranged from 1 to 1+ according to Modified Ashworth' Scale.
- They will be on level Ⅰ or Ⅱ on Growth Motor Function Classification System (GMFCS).
Who cannot join
- The Children will be excluded if they have one of the following:
- Severe visual or hearing impairment.
- Fixed deformities or surgical interventions in the lower extremities.
- Botulinum toxin injections in the last 6 months.
About this study
This study will be conducted to identify the relation between pelvic alignment and standing balance and also the relation between pelvic alignment and selective motor control in children with spastic diplegic cerebral palsy.
Read the detailed description
In this study, pelvic alignment of children with diplegia will be evaluated using the Formetric instrument system. Their standing balance will be evaluated using the Biodex balance system, while selective voluntary motor control of lower extremities will be assessed using the Selective Control Assessment of the Lower Extremity scale (SCALE).
Results will be compared to find the correlation between pelvic alignment and standing balance and the correlation between pelvic alignment and selective motor control. Results can help clinicians to better address the problems of pelvic asymmetry in children with spastic diplegia to improve their overall balance and functional abilities.
- Conditions
- Cerebral Palsy, Spastic Diplegia
- Keywords
- pelvic alignment, pelvic tilt, torsion, inclination, Formetric, Biodex, dynamic balance, selective motor control, SCALE
- Medical subject headings
- Cerebral Palsy
What is being measured
The primary outcome is the main question the study is designed to answer.
Pelvic alignment in relation to dynamic standing balance
Pelvic alignment will be assessed using the Formetric system, while standing balance will be assessed using the Biodex system then results will be compared to find the relation between pelvic alignment and dynamic standing balance in children with diplegia.
Measured: 2 months
Pelvic alignment in relation to selective voluntary motor control of the lower extremities
Pelvic alignment will be assessed using the Formetric system, while selective motor control (SMC) of lower extremities will be assessed using Selective Control Assessment of the Lower Extremity scale (SCALE) then results will be compared to find the relation between pelvic alignment and selective motor control in children with diplegia.
Measured: 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2021
- Study start1 Nov 2021 (estimated)
- Primary completion1 Dec 2021 (estimated)
- Study completion30 Dec 2021 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Naglaa Ezzat Abd Allah Mahmoud, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05014451
- Sponsor's protocol ID
- P.T.REC/012/003257
- Status last verified
- Oct 2021
- First submitted
- 14 Aug 2021
- Last updated
- 18 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pelvic Alignment in Relation to Standing Balance and Selective Motor Control in Children With Spastic Diplegia
- ClinicalTrials.gov ID
- NCT05014451
- Acronym / sponsor ID
- P.T.REC/012/003257
- Conditions
- Cerebral Palsy, Spastic Diplegia
- Keywords
- pelvic alignment, pelvic tilt, torsion, inclination, Formetric, Biodex, dynamic balance, selective motor control, SCALE
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Nov 2021 (estimated)
- Primary completion
- 1 Dec 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 20 Aug 2021 (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 be conducted to identify the relation between pelvic alignment and standing balance and also the relation between pelvic alignment and selective motor control in children with spastic diplegic cerebral palsy.
Detailed description
In this study, pelvic alignment of children with diplegia will be evaluated using the Formetric instrument system. Their standing balance will be evaluated using the Biodex balance system, while selective voluntary motor control of lower extremities will be assessed using the Selective Control Assessment of the Lower Extremity scale (SCALE).
Results will be compared to find the correlation between pelvic alignment and standing balance and the correlation between pelvic alignment and selective motor control. Results can help clinicians to better address the problems of pelvic asymmetry in children with spastic diplegia to improve their overall balance and functional abilities.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with spastic diplegia, their height will not be less than 1 meter to meet the requirements of assessment by the Biodex and Formetric systems. They will be able to stand without the use of an assistive device and they will be able to follow instructions and understand given orders.
Key inclusion criteria (3 listed)
- Their age will be ranged from 6 to 8 years.
- The degree of their spasticity will be ranged from 1 to 1+ according to Modified Ashworth' Scale.
- They will be on level Ⅰ or Ⅱ on Growth Motor Function Classification System (GMFCS).
Key exclusion criteria (4 listed)
- Severe visual or hearing impairment.
- Fixed deformities or surgical interventions in the lower extremities.
- Botulinum toxin injections in the last 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pelvic alignment in relation to dynamic standing balance
Time frame: 2 months
Pelvic alignment will be assessed using the Formetric system, while standing balance will be assessed using the Biodex system then results will be compared to find the relation between pelvic alignment and dynamic standing balance in children with diplegia.
Pelvic alignment in relation to selective voluntary motor control of the lower extremities
Time frame: 2 month
Pelvic alignment will be assessed using the Formetric system, while selective motor control (SMC) of lower extremities will be assessed using Selective Control Assessment of the Lower Extremity scale (SCALE) then results will be compared to find the relation between pelvic alignment and selective motor control in children with diplegia.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2021.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication will be shared.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy and Spastic Diplegia, run by Cairo University.
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 4 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 18 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Pelvic alignment in relation to dynamic standing balance (time frame: 2 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 18 Oct 2021.