Cerebral PalsyNCT06124352
Correlation Between Clinical Measurement Scales for Gross Motor Function
An observational study of Cerebral Palsy, run by Cairo University at 1 site in Egypt.
Trial summary
Evaluating and applying an early and consistent rehabilitation approach to children with neurological impairments requires a multidisciplinary approach that involves different specialists, including pediatricians, pediatric neurologists, professional therapists, and pediatric physical therapists. Read more about this study
- Who is it for?
- Ages 4 to 6 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Gross Motor Function Measurement - 66 (GMFM- 66), Bruininks- Oseretsky Motor Proficiency and the Peabody Developmental Motor Scale - Second Edition (PDMS-2
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 15 May 2023to 6 Oct 2023
- 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
- Child
Study population: In this single-group cross-sectional study design, 50 participants with diplegic CP from the ages of 4 and 6 years evaluated in a physical therapy outpatient clinic and receiving a physiotherapy program for at minimum 6 months were included
Who may be able to join
- children with spastic CP with the capability to keep a standing position alone for at minimum five seconds, and the grade of hypertonicity in the lower extremity varied from grade 1 to grade 2 on the Modified Ashworth Scale with the capability to collaborate and follow directives
Who cannot join
- Children were excluded If they had a serious neurological condition (epilepsy), orthopedic complications, leg surgery, botulinum toxin treatment in the lower extremity in the last 6 months before the study and suffered from advanced intellectual disability.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation Between Clinical Measurement Scales for Gross Motor Function in Children With Spastic Cerebral Palsy
Evaluating and applying an early and consistent rehabilitation approach to children with neurological impairments requires a multidisciplinary approach that involves different specialists, including pediatricians, pediatric neurologists, professional therapists, and pediatric physical therapists. Evaluation is essential to validate the judgment, monitor the source, and evaluate the mechanical function and related difficulties.
- Conditions
- Cerebral Palsy
- Being tested
- Gross Motor Function Measurement - 66 (GMFM- 66), Bruininks- Oseretsky Motor Proficiency, the Peabody Developmental Motor Scale - Second Edition (PDMS-2
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gross Motor Function Measurement - 66 (GMFM- 66)Diagnostic test
GMFM-66 was performed for participants established on self-independent motion, with importance on allocations, and motion. The emphasis is to detect the grade that greatest reveals the current skills and disabilities of the child regarding motor functions. The new Gross Motor Ability Estimator (GMAE) scoring method for test-retest reliability data showed a high level of stability of the GMFM-66 over time (ICC=0.9932) that did not differ since the original GMFM 88-item test-retest reliability
Bruininks- Oseretsky Motor ProficiencyDiagnostic test
The BOT-2 are scale used to evaluate fine and gross motion skill development. It's used to classify children with movement control limitation. The test is appropriate for those aged 4 to 21 years. The interrater reliability ranging from 0.92 to 0.99 and construct validity. r = 0.78 (0.56 - 0.86) (test grades / chronological age)
the Peabody Developmental Motor Scale - Second Edition (PDMS-2Diagnostic test
The PDMS-2 is a consistent test that evaluates a child's movement skills. It is norm-referenced and consists of three composites: Fine Motor (FM), Gross Motor (GM), and Total movement composites (TM). GM composite incorporates 151 points from four sub-tests: reflexes, stationary, locomotion, and object manipulation. A 3-point scale scored for each item, with 2 being the highest score. Definite criterion for score of 2 is given when the child achieves the item, 1 is given when the behavior is emerging but not fully met, and 0 is given when the child cannot achieve the point. The highest raw scores of the sub-tests range from 16 to 198. The test-retest reliability of PDMS-2 was found to be r = 0.85 [24, 25].
What is being measured
The primary outcome is the main question the study is designed to answer.
The principal purpose of this study is to find the correlation between the clinical measurement scales for gross motor function in young CP children
For this study, a correlation between these 3 categories of clinical measures scales was analyzed in diplegic patients.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start15 May 2023
- Primary completion28 Aug 2023
- Study completion6 Oct 2023
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
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 50 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
- NCT06124352
- Sponsor's protocol ID
- Clinical Measure Scales
- Status last verified
- Nov 2023
- First submitted
- 4 Nov 2023
- Last updated
- 9 Nov 2023
- 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 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Clinical Measurement Scales for Gross Motor Function in Children With Spastic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06124352
- Acronym / sponsor ID
- Clinical Measure Scales
- Conditions
- Cerebral Palsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 May 2023 (actual)
- Primary completion
- 28 Aug 2023 (actual)
- Study completion
- 6 Oct 2023 (actual)
- First posted
- 9 Nov 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.
Evaluating and applying an early and consistent rehabilitation approach to children with neurological impairments requires a multidisciplinary approach that involves different specialists, including pediatricians, pediatric neurologists, professional therapists, and pediatric physical therapists. Evaluation is essential to validate the judgment, monitor the source, and evaluate the mechanical function and related difficulties.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Age groups
- Child
- Study population
- In this single-group cross-sectional study design, 50 participants with diplegic CP from the ages of 4 and 6 years evaluated in a physical therapy outpatient clinic and receiving a physiotherapy program for at minimum 6 months were included
Key inclusion criteria (1 listed)
- children with spastic CP with the capability to keep a standing position alone for at minimum five seconds, and the grade of hypertonicity in the lower extremity varied from grade 1 to grade 2 on the Modified Ashworth Scale with the capability to collaborate and follow directives
Key exclusion criteria (1 listed)
- Children were excluded If they had a serious neurological condition (epilepsy), orthopedic complications, leg surgery, botulinum toxin treatment in the lower extremity in the last 6 months before the study and suffered from advanced intellectual disability.
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 |
|---|---|---|
| Gross Motor Function Measurement - 66 (GMFM- 66)GMFM-66 was performed for participants established on self-independent motion, with importance on allocations, and motion. The emphasis is to detect the grade that greatest reveals the current skills and disabilities of the child regarding motor functions. The new Gross Motor Ability Estimator (GMAE) scoring method for test-retest reliability data showed a high level of stability of the GMFM-66 over time (ICC=0.9932) that did not differ since the original GMFM 88-item test-retest reliability | Diagnostic test | – |
| Bruininks- Oseretsky Motor ProficiencyThe BOT-2 are scale used to evaluate fine and gross motion skill development. It's used to classify children with movement control limitation. The test is appropriate for those aged 4 to 21 years. The interrater reliability ranging from 0.92 to 0.99 and construct validity. r = 0.78 (0.56 - 0.86) (test grades / chronological age) | Diagnostic test | – |
| the Peabody Developmental Motor Scale - Second Edition (PDMS-2The PDMS-2 is a consistent test that evaluates a child's movement skills. It is norm-referenced and consists of three composites: Fine Motor (FM), Gross Motor (GM), and Total movement composites (TM). GM composite incorporates 151 points from four sub-tests: reflexes, stationary, locomotion, and object manipulation. A 3-point scale scored for each item, with 2 being the highest score. Definite criterion for score of 2 is given when the child achieves the item, 1 is given when the behavior is emerging but not fully met, and 0 is given when the child cannot achieve the point. The highest raw scores of the sub-tests range from 16 to 198. The test-retest reliability of PDMS-2 was found to be r = 0.85 [24, 25]. | Diagnostic test | – |
Primary outcome
The principal purpose of this study is to find the correlation between the clinical measurement scales for gross motor function in young CP children
Time frame: 6 months
For this study, a correlation between these 3 categories of clinical measures scales was analyzed in diplegic patients.
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 9 Nov 2023.
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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 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: finished, as of the sponsor's last update on 9 Nov 2023. 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?
The principal purpose of this study is to find the correlation between the clinical measurement scales for gross motor function in young CP children (time frame: 6 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 9 Nov 2023; AzTrials last refreshed its copy on 28 Oct 2026.