Diplegic Cerebral PalsyNCT05428865
Correlation Between Body Mass Index, Selective Motor Control and Functional Ability in Children With CP
An observational study of Diplegic Cerebral Palsy, run by Cairo University at 1 site in Egypt.
Trial summary
PURPOSE: To investigate the correlations between body mass index, spasticity, functional ability and isolated motor control in children with spastic diplegia. BACKGROUND: Cerebral palsy is primarily a disorder of movement and posture HYPOTHESES: There is no correlation between body mass index, spasticity, functional… Read more about this study
- Who is it for?
- Ages 6 to 9 years
- Conditions the study is for
- Diplegic Cerebral Palsy
- What is being tested?
- correlation study
- How many people
- 84 participants
- Where
- 1 siteEgypt
- Study dates
- 24 Jan 2022to 24 Jul 2022
- 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 9 years
- All sexes
- No healthy volunteers
- Child
Study population: spastic diplegic cerebral palsy children
Who may be able to join
- spastic diplegic CP, age from 6 to 9 years, able to follow verbal commands or instructions during testing procedures, 1+ and 2 according to Modified Ashworth scale (MAS), (GMFCS E\&R) selected Level II , III.
Who cannot join
- patients who had contractures or fixed deformities related to the joints of the lower limbs, injection with Botulinium toxin or any orthopaedic surgery in lower limbs within one year before study,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation Between Body Mass Index, Selective Motor Control, Spasticity and Functional Ability in Children With Diplegic Cerebral Palsy
PURPOSE:
To investigate the correlations between body mass index, spasticity, functional ability and isolated motor control in children with spastic diplegia.
BACKGROUND:
Cerebral palsy is primarily a disorder of movement and posture
HYPOTHESES:
There is no correlation between body mass index, spasticity, functional ability and isolated motor control in children with spastic diplegia.
RESEARCH QUESTION:
Is there a correlation between body mass index, spasticity, functional ability and isolated motor control in children with spastic diplegia?
Read the detailed description
This is an observational correlational study. SCALE will be used to assess selective motor control of lower extremity. GMFM-88 and WEE FIM will be used to assess functional ability. MAS will be used to assess degree of spasticity
- Conditions
- Diplegic Cerebral Palsy
- Being tested
- correlation study
- Keywords
- isolated motor control, functional ability, body mass index, cerebral palsy
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
correlation studyOther
investigate the correlations between body mass index, spasticity, functional ability and isolated motor control in children with spastic diplegia.
What is being measured
The primary outcome is the main question the study is designed to answer.
The selective control assessment of lower extremity (SCALE)
is a tool used for assessment of SVMC in children with spastic CP.
Measured: through study completion, an average of 1 year
Anthropometric measurements
include weight (measured using a calibrated digital scale and height (measured using Harpenden Stadiometer). Body mass index (BMI) was calculated as weight (kg)/height (m2). higher scores indicate obesity
Measured: through study completion, an average of 1 year
Wee Functional Independence Measure (Wee-FIM)
is a tool used to assess activities of daily living (ADL) in children with cerebral palsy.
Measured: through study completion, an average of 1 year
Secondary outcomes (2)
Modified Ashworth Scale (MAS)
For grading degree of spasticity.
Measured: through study completion, an average of 1 year
Gross Motor Function Classification System Expanded and Revised for CP children between 6th and 12th birthday:
The Gross Motor Function Classification System (GMFCS E\&R) is a classification system that describes the level of gross motor function of CP children according to abilities and limitations
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2022
- Study start24 Jan 2022
- Primary completion1 Jun 2022
- Study completion24 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diplegic 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
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Fahmy Hassan Al Nemr, Cairo University
- Investigators
- Faculty OP Therapy, lecturer, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05428865
- Sponsor's protocol ID
- P.T.REC/012/003833
- Status last verified
- Feb 2023
- First submitted
- 11 Jun 2022
- Last updated
- 14 Feb 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 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Body Mass Index, Selective Motor Control, Spasticity and Functional Ability in Children With Diplegic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05428865
- Acronym / sponsor ID
- P.T.REC/012/003833
- Conditions
- Diplegic Cerebral Palsy
- Keywords
- isolated motor control, functional ability, body mass index, cerebral palsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 24 Jan 2022 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 24 Jul 2022 (actual)
- First posted
- 23 Jun 2022 (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.
PURPOSE:
To investigate the correlations between body mass index, spasticity, functional ability and isolated motor control in children with spastic diplegia.
BACKGROUND:
Cerebral palsy is primarily a disorder of movement and posture
HYPOTHESES:
There is no correlation between body mass index, spasticity, functional ability and isolated motor control in children with spastic diplegia.
RESEARCH QUESTION:
Is there a correlation between body mass index, spasticity, functional ability and isolated motor control in children with spastic diplegia?
Detailed description
This is an observational correlational study. SCALE will be used to assess selective motor control of lower extremity. GMFM-88 and WEE FIM will be used to assess functional ability. MAS will be used to assess degree of spasticity
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- spastic diplegic cerebral palsy children
Key inclusion criteria (1 listed)
- spastic diplegic CP, age from 6 to 9 years, able to follow verbal commands or instructions during testing procedures, 1+ and 2 according to Modified Ashworth scale (MAS), (GMFCS E\&R) selected Level II , III.
Key exclusion criteria (1 listed)
- patients who had contractures or fixed deformities related to the joints of the lower limbs, injection with Botulinium toxin or any orthopaedic surgery in lower limbs within one year before 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 |
|---|---|---|
| correlation studyinvestigate the correlations between body mass index, spasticity, functional ability and isolated motor control in children with spastic diplegia. | Other | – |
Primary outcome
The selective control assessment of lower extremity (SCALE)
Time frame: through study completion, an average of 1 year
is a tool used for assessment of SVMC in children with spastic CP.
Anthropometric measurements
Time frame: through study completion, an average of 1 year
include weight (measured using a calibrated digital scale and height (measured using Harpenden Stadiometer). Body mass index (BMI) was calculated as weight (kg)/height (m2). higher scores indicate obesity
Wee Functional Independence Measure (Wee-FIM)
Time frame: through study completion, an average of 1 year
is a tool used to assess activities of daily living (ADL) in children with cerebral palsy.
2 secondary outcomes
Modified Ashworth Scale (MAS)
Time frame: through study completion, an average of 1 year
Gross Motor Function Classification System Expanded and Revised for CP children between 6th and 12th birthday:
Time frame: through study completion, an average of 1 year
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 14 Feb 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.
Faculty OP Therapy, lecturer principal investigator
Cairo University
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 Diplegic 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 14 Feb 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 selective control assessment of lower extremity (SCALE) (time frame: through study completion, an average of 1 year). 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 14 Feb 2023.