Correlation of Pelvic Asymmetry and Joint Movement During Gait in Children With Cerebral PalsyNCT06051422
Correlation of Pelvic Asymmetry and Joint Movement During Gait in Children With Cerebral Palsy
An observational study of Correlation of Pelvic Asymmetry and Joint Movement During Gait in Children With Cerebral Palsy, run by Cairo University at 1 site in Egypt.
Trial summary
the study's particular goals were to determine whether excessive hip, knee, and ankle displacement at first contact during locomotion correlates with pelvic rotation. Read more about this study
- Who is it for?
- Ages 4 to 6 years
- Conditions the study is for
- Correlation of Pelvic Asymmetry and Joint Movement During Gait in Children With Cerebral Palsy
- What is being tested?
- three dimensional formetric system
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Feb 2023to 30 Jan 2024
- 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 4 to 6 years
- All sexes
- No healthy volunteers
- Child
Study population: 20 kids with spastic cerebral palsy
Who may be able to join
- the lower extremities' degree of spasticity ranged from grade 1 to grade +1 on the Gross Motor Function Classification System (GMFCS) [7] classified motor function levels as being between levels I and II. Children have the cognitive ability to understand and follow instructions.
Who cannot join
- having an extensive intellectual disability, orthopedic issues, upper or lower limb surgery, visual or hearing issues, usage of behavior-altering medicines, or a major neurological illness (epilepsy)
Trial locations and contacts
1 site in 1 country.
About this study
the study's particular goals were to determine whether excessive hip, knee, and ankle displacement at first contact during locomotion correlates with pelvic rotation.
- Conditions
- Correlation of Pelvic Asymmetry and Joint Movement During Gait in Children With Cerebral Palsy
- Being tested
- three dimensional formetric system
- Keywords
- Cerebral palsy, pelvic obliquity, joint movement
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
three dimensional formetric systemDevice
Also called digital cameras
A three-dimensional computer program that automatically detects pelvic torsion, surface rotation, and anatomical landmarks. Aesculap-Meditec GMBH, based in the Netherlands, creates the Formetric Instrument System. Different subject heights could be accommodated by adjusting the scanner.
What is being measured
The primary outcome is the main question the study is designed to answer.
pelvic asymmetry and joints movement measures
A three-dimensional computer program that automatically detects pelvic torsion, surface rotation, and anatomical landmarks. Aesculap-Meditec GMBH, based in the Netherlands, creates the Formetric Instrument System. Different subject heights could be accommodated by adjusting the scanner. the Unit of measures detected by degrees
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start12 Feb 2023
- Primary completion20 May 2023
- Study completion30 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Correlation of Pelvic Asymmetry and Joint Movement During Gait in Children With 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shimaa Mohamed Reffat, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06051422
- Sponsor's protocol ID
- P.T. REC/012/004462
- Status last verified
- Jan 2024
- First submitted
- 25 Jul 2023
- Last updated
- 17 Jan 2024
- 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 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Pelvic Asymmetry and Joint Movement During Gait in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06051422
- Acronym / sponsor ID
- P.T. REC/012/004462
- Conditions
- Correlation of Pelvic Asymmetry and Joint Movement During Gait in Children With Cerebral Palsy
- Keywords
- Cerebral palsy, pelvic obliquity, joint movement
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 12 Feb 2023 (actual)
- Primary completion
- 20 May 2023 (actual)
- Study completion
- 30 Jan 2024 (estimated)
- First posted
- 22 Sep 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.
the study's particular goals were to determine whether excessive hip, knee, and ankle displacement at first contact during locomotion correlates with pelvic rotation.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 20 kids with spastic cerebral palsy
Key inclusion criteria (1 listed)
- the lower extremities' degree of spasticity ranged from grade 1 to grade +1 on the Gross Motor Function Classification System (GMFCS) [7] classified motor function levels as being between levels I and II. Children have the cognitive ability to understand and follow instructions.
Key exclusion criteria (1 listed)
- having an extensive intellectual disability, orthopedic issues, upper or lower limb surgery, visual or hearing issues, usage of behavior-altering medicines, or a major neurological illness (epilepsy)
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 |
|---|---|---|
| three dimensional formetric systemAlso: digital camerasA three-dimensional computer program that automatically detects pelvic torsion, surface rotation, and anatomical landmarks. Aesculap-Meditec GMBH, based in the Netherlands, creates the Formetric Instrument System. Different subject heights could be accommodated by adjusting the scanner. | Device | – |
Primary outcome
pelvic asymmetry and joints movement measures
Time frame: 2 months
A three-dimensional computer program that automatically detects pelvic torsion, surface rotation, and anatomical landmarks. Aesculap-Meditec GMBH, based in the Netherlands, creates the Formetric Instrument System. Different subject heights could be accommodated by adjusting the scanner. the Unit of measures detected by degrees
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
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?
An observational study of Correlation of Pelvic Asymmetry and Joint Movement During Gait in Children With 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 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: status not confirmed, as of the sponsor's last update on 17 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?
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 asymmetry and joints movement measures (time frame: 2 months). 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 17 Jan 2024.