Spastic Diplegia Cerebral PalsyBMINCT06642922
Gross Motor Abnormalities in Relation to Balance and Weight Indicators in Diplegia
An observational study of Spastic Diplegia Cerebral Palsy, run by Lamis Neyazy Elrakhawy at 1 site in Egypt.
Trial summary
The goal of this observational study is to investigate the correlation between BMI and balance and gross motor capacities in children with spastic diplegia. The main question it aims to answer is: Is there a correlation between BMI, balance disturbances and gross motor capacity in children with spastic diplegic… Read more about this study
- Who is it for?
- Ages 5 to 10 years
- Conditions the study is for
- Spastic Diplegia Cerebral Palsy
- How many people
- 104 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Oct 2022to 12 Jul 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 5 to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: children with spastic diplegia aged from 5 to 10 years old
Who may be able to join
- Children selected according to the following criteria:
- Diagnosed with diplegic CP
- Their ages will range between 5 and 10 years
- Subjects will participate according to BMI classification ; normal weight in the first group and (obese , overweight) in the second group .
- They must be able to stand independently.
- Have minimum height of 100 cm.
- Have a developmental level of grade I or II according to gross motor function classification system GMFM.
- Able to understand and follow instructions.
Who cannot join
- Auditory defects.
- Visual defects.
- Cognitive or vestibular defects.
- Use of an assistive device.
- Fixed deformity, bony or joint limitation.
- Surgery (tendon lengthening).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation Between BMI , Balance and Gross Motor Capacities in Children with Spastic Diplegia
The goal of this observational study is to investigate the correlation between BMI and balance and gross motor capacities in children with spastic diplegia. The main question it aims to answer is:
Is there a correlation between BMI, balance disturbances and gross motor capacity in children with spastic diplegic cerebral palsy? Researchers compared between results of biodex balance system , GMFM and BMI measures participants stood on biodex balance platform for balance measurement and performed Gross Motor Function Measurement items for gross motor capacities assessment
Read the detailed description
Spastic diplegia is the most common type of CP that results in problems with posture, balance, as well as gait control. For children suffering from spastic diplegic CP, balance problems provide a significant difficulty since they make it difficult for them to achieve and maintain balance . Additionally, they commonly demonstrate delayed development of gross motor function that has been connected to functional outcomes, such as daily living tasks . The prevalence of obesity in the CP population has risen over the last decade from 7.7 to 16.5 %. . Obesity is associated with health risks and difficulties in balance and walking. this cross-sectional-correlation study was conducted at the Outpatient Clinic at the Faculty of Physical Therapy, Cairo University. The study included 104 diplegic children aged from 5-10 years, 53 in normal weight group and 51 in overweight group. Dynamic balance was evaluated by overall stability index (OSI) in biodex balance system and gross motor capacities (GMC) were evaluated by standing \&walking dimensions in GMFM
- Conditions
- Spastic Diplegia Cerebral Palsy
- Keywords
- BMI, Balance, Gross motor capacities, obesity, diplegia
- Medical subject headings
- Cerebral palsy, spastic, diplegic, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| group 1 | normal weight group , 53 participants BMI , balance , and gross motor capacities were assessed for each participant | |
| group 2 | overweight and obese group , 51 participants BMI , balance , and gross motor capacities were assessed for each participant |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI
Standardized height-weight measuring scale for measurement of weight and height, to be able to calculate BMI Growth charts were used to plot BMI and age separately for girls and boys. Then, each subject was given a percentile and put into one of two categories: normal (5th to 85th percentile) and overweight, obese (85th and above percentile).
Measured: 9 months
balance assessment
Biodex balance system SD with movable platform was used .The overall stability index (OSI) will be measured as indicator of dynamic balance. The higher the OSI values, the lower the dynamic balance stability. Bilateral stance (standing on both legs), eyes open, stability level 5 (12 is the most stable level), and three repeated trials (for more accuracy) for 20 seconds (test time for each trial) were the test conditions
Measured: 9 months
Secondary outcomes (1)
gross motor capacities
GMC assessed by using dimensions D and E of the Gross Motor Function Measure (GMFM-88) which measures respectively activities in standing, and walking, running, and jumping. . A 4-point scale was used and scores were expressed as percentages
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start20 Oct 2022
- Primary completion15 Jun 2023
- Study completion12 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spastic Diplegia Cerebral PalsyStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lamis Neyazy Elrakhawy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lamis Neyazy Elrakhawy, Cairo University
- Investigators
- khaled A Mamdouh, Principal investigator, Department of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo UniversityHoda A Eltalawy, Study director, Department of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo UniversityRadwa s Abdulrahman, Study director, Department of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06642922
- Sponsor's protocol ID
- P.T.REC/012/004585
- Other IDs
- faculty of physical therapy
- Acronym
- BMI
- Status last verified
- Aug 2021
- First submitted
- 10 Oct 2024
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between BMI , Balance and Gross Motor Capacities in Children with Spastic Diplegia
- ClinicalTrials.gov ID
- NCT06642922
- Acronym / sponsor ID
- BMI / P.T.REC/012/004585
- Conditions
- Spastic Diplegia Cerebral Palsy
- Keywords
- BMI, Balance, Gross motor capacities, obesity, diplegia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Lamis Neyazy ElrakhawyUniversity, hospital or other
- Study start
- 20 Oct 2022 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 12 Jul 2023 (actual)
- First posted
- 15 Oct 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.
The goal of this observational study is to investigate the correlation between BMI and balance and gross motor capacities in children with spastic diplegia. The main question it aims to answer is:
Is there a correlation between BMI, balance disturbances and gross motor capacity in children with spastic diplegic cerebral palsy? Researchers compared between results of biodex balance system , GMFM and BMI measures participants stood on biodex balance platform for balance measurement and performed Gross Motor Function Measurement items for gross motor capacities assessment
Detailed description
Spastic diplegia is the most common type of CP that results in problems with posture, balance, as well as gait control. For children suffering from spastic diplegic CP, balance problems provide a significant difficulty since they make it difficult for them to achieve and maintain balance . Additionally, they commonly demonstrate delayed development of gross motor function that has been connected to functional outcomes, such as daily living tasks . The prevalence of obesity in the CP population has risen over the last decade from 7.7 to 16.5 %. . Obesity is associated with health risks and difficulties in balance and walking. this cross-sectional-correlation study was conducted at the Outpatient Clinic at the Faculty of Physical Therapy, Cairo University. The study included 104 diplegic children aged from 5-10 years, 53 in normal weight group and 51 in overweight group. Dynamic balance was evaluated by overall stability index (OSI) in biodex balance system and gross motor capacities (GMC) were evaluated by standing \&walking dimensions in GMFM
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | – | –normal weight group , 53 participants BMI , balance , and gross motor capacities were assessed for each participant |
| group 2 | – | –overweight and obese group , 51 participants BMI , balance , and gross motor capacities were assessed for each participant |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- children with spastic diplegia aged from 5 to 10 years old
Key inclusion criteria (8 listed)
- Diagnosed with diplegic CP
- Their ages will range between 5 and 10 years
- Subjects will participate according to BMI classification ; normal weight in the first group and (obese , overweight) in the second group .
- They must be able to stand independently.
- Have minimum height of 100 cm.
Key exclusion criteria (6 listed)
- Auditory defects.
- Visual defects.
- Cognitive or vestibular defects.
- Use of an assistive device.
- Fixed deformity, bony or joint limitation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
BMI
Time frame: 9 months
Standardized height-weight measuring scale for measurement of weight and height, to be able to calculate BMI Growth charts were used to plot BMI and age separately for girls and boys. Then, each subject was given a percentile and put into one of two categories: normal (5th to 85th percentile) and overweight, obese (85th and above percentile).
balance assessment
Time frame: 9 months
Biodex balance system SD with movable platform was used .The overall stability index (OSI) will be measured as indicator of dynamic balance. The higher the OSI values, the lower the dynamic balance stability. Bilateral stance (standing on both legs), eyes open, stability level 5 (12 is the most stable level), and three repeated trials (for more accuracy) for 20 seconds (test time for each trial) were the test conditions
1 secondary outcome
gross motor capacities
Time frame: 9 months
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 17 Oct 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.
khaled A Mamdouh principal investigator
Department of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University
Hoda A Eltalawy study director
Department of Physical Therapy for Pediatrics, Faculty of Physical Therapy, Cairo University
Radwa s Abdulrahman study director
Department of Physical Therapy for Pediatrics, Faculty of Physical Therapy, 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 Spastic Diplegia Cerebral Palsy, run by Lamis Neyazy Elrakhawy 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 8 inclusion and 6 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 17 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?
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?
BMI (time frame: 9 months). The study lists 2 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 17 Oct 2024.