Spastic Cerebral PalsyNCT06481722
Knee Joint Angle Affect Muscle Architecture in Children With Cerebral Palsy
An observational study of Spastic Cerebral Palsy, run by Cairo University at 1 site in Egypt.
Trial summary
To determine if there is an effect of knee joint angle on muscle architecture in children with spastic cerebral palsy Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Spastic Cerebral Palsy
- What is being tested?
- cerebral palsy
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Apr 2023to 20 Mar 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 3 to 6 years
- All sexes
- Child
Study population: To determine if there is an effect of knee joint angle on muscle architecture in children with spastic cerebral palsy, 40 diplegic cerebral palsy children of both sexes will participate in this study.
Who may be able to join
- A diagnosis of spastic diplegia CP.
- Age from 3 to 6 years.
- Spasticity grade 1 and 1+ according to the Modified Ashworth scale.
- Level III motor function according to the Growth Motor Function Classification System.
- Hamstring muscle tightness.
- Able to understand and follow instructions.
Who cannot join
- Epilepsy.
- Significant visual or auditory problems according to medical reports (audio-vestibular and ophthalmic examination).
- Structural or fixed soft tissue deformities of the lower extremities.
- Neurological or orthopedic surgery in the past 12 months.
- Botox injection in the lower extremities in the past 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Knee Joint Angle Affect Muscle Architecture in Children With Spastic Cerebral Palsy?
To determine if there is an effect of knee joint angle on muscle architecture in children with spastic cerebral palsy
Read the detailed description
To determine if there is an effect of knee joint angle on muscle architecture in children with spastic cerebral palsy
- Conditions
- Spastic Cerebral Palsy
- Being tested
- cerebral palsy
- Keywords
- muscle architecture, knee joint angle, cerebral palsy, spasticity, children
- Medical subject headings
- Cerebral Palsy, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cerebral palsyOther
no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Fascicle length
Fascicle length will be measured by ultrasonography
Measured: 3 months
knee joint angle will be measured by digital Goniometer
knee joint angle will be measured by digital Goniometer
Measured: 3 months
pennation angle
pennation angle will be measured by ultrasonography
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2024
- Study start10 Apr 2023
- Primary completion20 Nov 2023
- Study completion20 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spastic 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
- Case crossover
- Time perspective
- Retrospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa S Ali, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06481722
- Sponsor's protocol ID
- P.T.REC/012/ 004995
- Status last verified
- Jun 2024
- First submitted
- 22 Jun 2024
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Knee Joint Angle Affect Muscle Architecture in Children With Spastic Cerebral Palsy?
- ClinicalTrials.gov ID
- NCT06481722
- Acronym / sponsor ID
- P.T.REC/012/ 004995
- Conditions
- Spastic Cerebral Palsy
- Keywords
- muscle architecture, knee joint angle, cerebral palsy, spasticity, children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Apr 2023 (actual)
- Primary completion
- 20 Nov 2023 (actual)
- Study completion
- 20 Mar 2024 (actual)
- First posted
- 1 Jul 2024 (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.
To determine if there is an effect of knee joint angle on muscle architecture in children with spastic cerebral palsy
Detailed description
To determine if there is an effect of knee joint angle on muscle architecture in children with spastic cerebral palsy
Study design
- Observational model
- Case crossover
- Time perspective
- Retrospective
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Age groups
- Child
- Study population
- To determine if there is an effect of knee joint angle on muscle architecture in children with spastic cerebral palsy, 40 diplegic cerebral palsy children of both sexes will participate in this study.
Key inclusion criteria (6 listed)
- A diagnosis of spastic diplegia CP.
- Age from 3 to 6 years.
- Spasticity grade 1 and 1+ according to the Modified Ashworth scale.
- Level III motor function according to the Growth Motor Function Classification System.
- Hamstring muscle tightness.
Key exclusion criteria (5 listed)
- Epilepsy.
- Significant visual or auditory problems according to medical reports (audio-vestibular and ophthalmic examination).
- Structural or fixed soft tissue deformities of the lower extremities.
- Neurological or orthopedic surgery in the past 12 months.
- Botox injection in the lower extremities in the past 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cerebral palsyno intervention | Other | – |
Primary outcome
Fascicle length
Time frame: 3 months
Fascicle length will be measured by ultrasonography
knee joint angle will be measured by digital Goniometer
Time frame: 3 months
knee joint angle will be measured by digital Goniometer
pennation angle
Time frame: 3 months
pennation angle will be measured by ultrasonography
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 1 Jul 2024.
- Individual participant dataSharing planned: No
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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?
An observational study of Spastic 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 6 inclusion and 5 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 1 Jul 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?
Fascicle length (time frame: 3 months). The study lists 3 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 1 Jul 2024.