Cerebral PalsyNCT06601569
Predictors of Range of Motion and Balance Abnormalities in Children Diagnosed with Cerebral Palsy
An observational study of Cerebral Palsy, run by Cairo University at 1 site in Egypt.
Trial summary
1. To better understand the factors that contribute to ROM abnormalities in children diagnosed with CP. 2. To describe the distribution of primary (muscle tone and postural stability)and secondary impairments (ROM and functional muscle strength) across the gross motor spectrum measured by GMFCS scores. 3. Read more about this study
- Who is it for?
- Ages 18 months to 5 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- balance and range of motion
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2024to 1 Feb 2025
- 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 18 months to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: children with cerebral plasy their age ranged fro 18 month t 5 yeas old
Who may be able to join
- only children with clinical diagnosis of cerebral palsy , who were receiving physiotherapy services at the paediatric out-patient clinic of Faculty of Physical Therapy, Cairo University for a minimum of six months regularly.
Who cannot join
- Children were excluded if they had one or more of the following: behavioral issues, a history of persistent heart or chest disease, significant visual or auditory impairment, botulinum toxin injection at last six months prior to the study.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Physical Therapy Cairo University
Cairo, Cairo Governorate
mahmoud usama, +21285221209, afekry335@gmail.com
About this study
- To better understand the factors that contribute to ROM abnormalities in children diagnosed with CP.
- To describe the distribution of primary (muscle tone and postural stability)and secondary impairments (ROM and functional muscle strength) across the gross motor spectrum measured by GMFCS scores.
- To evaluate the effects of primary and secondary impairments on gross functional outcome in children with spastic CP.
- To find any possible correlation between clinical variables.
- Conditions
- Cerebral Palsy
- Being tested
- balance and range of motion
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
balance and range of motionDiagnostic test
Also called Spinal alignment and range of motion measure scale, Modified Ashworth scale (MAS), Early clinical assessment of balance (ECAB) scale, Functional strength assessment scale
- Spinal alignment and range of motion measure scale (SAROMM): is a measure of spinal alignment and range of motion using standard physical therapy techniques scored on a 5-point ordinal score of 0 (normal alignment and range with active correction) to4 ("severe" fixed deformity) (Bartlett ey al., 2005)
- Modified Ashworth scale (MAS): is a measure of muscle motion and scoring the perceived resistance to movement on a scale of 1 (no increase in tone) to 5 (rigid in flexion or extension) (Clopton et al., 2005).
- Early clinical assessment of balance (ECAB) scale: Is a 13-item test that estimates postural stability for children with CP across all levels of functional ability (Jeffries etal., 2016).
- Functional strength assessment scale: Therapists completed a functional strength assessment (FSA) to obtain an estimate of strength for major muscle groups including the neck and trunk flexors and extensors, and hip extensors, knee extensors, and shoulder flexors bilaterally.
| Study group | Role | What they receive |
|---|---|---|
| diplegic cerebral palsy | Not described Receives: Diagnostic Test: balance and range of motion | |
| quadripledic cerebral palsy | Not described Receives: Diagnostic Test: balance and range of motion | |
| hemiplegic cerebral palsy | Not described Receives: Diagnostic Test: balance and range of motion | |
| dyskinetic cerebral palsy | Not described Receives: Diagnostic Test: balance and range of motion |
What is being measured
The primary outcome is the main question the study is designed to answer.
predictors of range of motion and balance abnormalities
the aim of the study is to investigate the predicted cause if the range of motion abnormalities measured by (spinal alignment and range of motion assessment scale ) and balance abnormalities ( measured by early clinical assessment of balance scale )in children with cerebral palsy like muscle strength (measured by functional muscle strength scale) and muscle tone changes (measured by modified athwart scale)
Measured: from 1 august 2024 to 1 october 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Aug 2024
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Feb 2025 (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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed fekry ibrahim salman, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06601569
- Sponsor's protocol ID
- P.T.REC/012/005209
- Status last verified
- Sep 2024
- First submitted
- 27 Jul 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Range of Motion and Balance Abnormalities in Children Diagnosed with Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06601569
- Acronym / sponsor ID
- P.T.REC/012/005209
- Conditions
- Cerebral Palsy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 19 Sep 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 better understand the factors that contribute to ROM abnormalities in children diagnosed with CP.
- To describe the distribution of primary (muscle tone and postural stability)and secondary impairments (ROM and functional muscle strength) across the gross motor spectrum measured by GMFCS scores.
- To evaluate the effects of primary and secondary impairments on gross functional outcome in children with spastic CP.
- To find any possible correlation between clinical variables.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| diplegic cerebral palsy | – | Diagnostic Test: balance and range of motion |
| quadripledic cerebral palsy | – | Diagnostic Test: balance and range of motion |
| hemiplegic cerebral palsy | – | Diagnostic Test: balance and range of motion |
| dyskinetic cerebral palsy | – | Diagnostic Test: balance and range of motion |
Who may qualify
- Ages
- 18 months to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- children with cerebral plasy their age ranged fro 18 month t 5 yeas old
Key inclusion criteria (1 listed)
- only children with clinical diagnosis of cerebral palsy , who were receiving physiotherapy services at the paediatric out-patient clinic of Faculty of Physical Therapy, Cairo University for a minimum of six months regularly.
Key exclusion criteria (1 listed)
- Children were excluded if they had one or more of the following: behavioral issues, a history of persistent heart or chest disease, significant visual or auditory impairment, botulinum toxin injection at last six months prior to the study.
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 |
|---|---|---|
| balance and range of motionAlso: Spinal alignment and range of motion measure scale, Modified Ashworth scale (MAS), Early clinical assessment of balance (ECAB) scale, Functional strength assessment scale* Spinal alignment and range of motion measure scale (SAROMM): is a measure of spinal alignment and range of motion using standard physical therapy techniques scored on a 5-point ordinal score of 0 (normal alignment and range with active correction) to4 ("severe" fixed deformity) (Bartlett ey al., 2005) * Modified Ashworth scale (MAS): is a measure of muscle motion and scoring the perceived resistance to movement on a scale of 1 (no increase in tone) to 5 (rigid in flexion or extension) (Clopton et al., 2005). * Early clinical assessment of balance (ECAB) scale: Is a 13-item test that estimates postural stability for children with CP across all levels of functional ability (Jeffries etal., 2016). * Functional strength assessment scale: Therapists completed a functional strength assessment (FSA) to obtain an estimate of strength for major muscle groups including the neck and trunk flexors and extensors, and hip extensors, knee extensors, and shoulder flexors bilaterally. | Diagnostic test | diplegic cerebral palsy, dyskinetic cerebral palsy, hemiplegic cerebral palsy, quadripledic cerebral palsy |
Primary outcome
predictors of range of motion and balance abnormalities
Time frame: from 1 august 2024 to 1 october 2024
the aim of the study is to investigate the predicted cause if the range of motion abnormalities measured by (spinal alignment and range of motion assessment scale ) and balance abnormalities ( measured by early clinical assessment of balance scale )in children with cerebral palsy like muscle strength (measured by functional muscle strength scale) and muscle tone changes (measured by modified athwart scale)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Individual participant dataSharing planned: Yes
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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?
An observational study of 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 1 Oct 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?
Contact ahmed fekry salman (+201067873174, a.salman@ammanu.edu.jo), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
predictors of range of motion and balance abnormalities (time frame: from 1 august 2024 to 1 october 2024). 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 Oct 2024.