Cerebral PalsyCPNCT06531044
Relationship Between Gross Motor Coordination and Balance in Children With Spastic Cerebral Palsy
An observational study of Cerebral Palsy, run by Sinai University at 1 site in Egypt.
Trial summary
This study aims to determine if there is a connection between gross motor coordination and balance in children with spastic cerebral palsy. Since these children often struggle with balance and other motor skills, researchers hypothesize that there is no link between the two abilities. Read more about this study
- Who is it for?
- Ages 5 to 11 years
- Conditions the study is for
- Cerebral Palsy
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Mar 2024to 20 Nov 2024
- How long will I take part?
- 1 Day
- 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 11 years
- All sexes
- No healthy volunteers
- Child
Study population: Children with spastic cerebral palsy
Who may be able to join
- They were scored Level I on the Gross Motor Function Classification System (GMFCS).
- The subjects' age was from five to eleven years.
- They were at least 1-meter-tall and not less 20 Kg.
- They had to comprehend verbal commands.
- They were score 1 to 1+ based on Modified Ashworth' Scale.
Who cannot join
- Contracture, deformity and/or tightness in upper or lower limbs.
- Botulinum toxin in the last year.
- Recent fracture.
- Vertigo or dizziness.
- Epilepsy.
- Osteoporosis.
- Recent operation in the six months at least (according to the type of operation).
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Sinai University
Ismailia
alaan.kora@gmail.com
Alaa N Kora
About this study
This study aims to determine if there is a connection between gross motor coordination and balance in children with spastic cerebral palsy. Since these children often struggle with balance and other motor skills, researchers hypothesize that there is no link between the two abilities.
Read the detailed description
PURPOSE:
To examine the relationship between the gross motor coordination and balance in children with spastic cerebral palsy.
BACKGROUND:
Motor coordination is required for the effective acquisition of movements and effortless performance. Gross motor coordination involves numerous skills, including balance, bilateral movement, agility, and speed. Children with cerebral palsy exhibit a deterioration in gross motor coordination ability.
The lack of postural control in children with cerebral palsy impairs functional balance. According to studies, children with cerebral palsy have poorer static and dynamic balance responses than typically developing children.
HYPOTHESES:
- There is no relationship between gross motor coordination and balance in children with spastic cerebral palsy.
RESEARCH QUESTION:
- Is there a relationship between gross motor coordination and balance in children with spastic cerebral palsy.
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral Palsy, Balance, Gross Motor Coordination
- Medical subject headings
- Cerebral Palsy
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 |
|---|---|---|
| 1 of children with cerebral palsy | Children with spastic cerebral palsy will be enrolled in this study upon fulfilling the following inclusion criteria: They were scored Level I on the Gross Motor Function Classification System (GMFCS). |
What is being measured
The primary outcome is the main question the study is designed to answer.
balance.
Biodex Balance System will be used to assess balance.
Measured: 1 day - one session
gross motor coordination.
- Gross Motor - BOT -2 will be used to assess gross motor coordination.
Measured: 1 day - one session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2024
- Study start6 Mar 2024
- Primary completion20 Nov 2024 (estimated)
- Study completion20 Nov 2024 (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.
- 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
- 60 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Sinai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Noureldeen Kora, Sinai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06531044
- Sponsor's protocol ID
- P.T.REC/012/005131
- Acronym
- CP
- Status last verified
- Jul 2024
- First submitted
- 28 Jul 2024
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Sharing Individual Patient Data (IPD) is often hindered by privacy concerns, data security risks, legal and ethical obligations, resource limitations, and data quality issues.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Gross Motor Coordination and Balance in Children With Spastic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT06531044
- Acronym / sponsor ID
- CP / P.T.REC/012/005131
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral Palsy, Balance, Gross Motor Coordination
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sinai UniversityUniversity, hospital or other
- Study start
- 6 Mar 2024 (actual)
- Primary completion
- 20 Nov 2024 (estimated)
- Study completion
- 20 Nov 2024 (estimated)
- First posted
- 31 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.
This study aims to determine if there is a connection between gross motor coordination and balance in children with spastic cerebral palsy. Since these children often struggle with balance and other motor skills, researchers hypothesize that there is no link between the two abilities.
Detailed description
PURPOSE:
To examine the relationship between the gross motor coordination and balance in children with spastic cerebral palsy.
BACKGROUND:
Motor coordination is required for the effective acquisition of movements and effortless performance. Gross motor coordination involves numerous skills, including balance, bilateral movement, agility, and speed. Children with cerebral palsy exhibit a deterioration in gross motor coordination ability.
The lack of postural control in children with cerebral palsy impairs functional balance. According to studies, children with cerebral palsy have poorer static and dynamic balance responses than typically developing children.
HYPOTHESES:
- There is no relationship between gross motor coordination and balance in children with spastic cerebral palsy.
RESEARCH QUESTION:
- Is there a relationship between gross motor coordination and balance in children with spastic cerebral palsy.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 of children with cerebral palsy | – | –Children with spastic cerebral palsy will be enrolled in this study upon fulfilling the following inclusion criteria: They were scored Level I on the Gross Motor Function Classification System (GMFCS). |
Who may qualify
- Ages
- 5 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with spastic cerebral palsy
Key inclusion criteria (5 listed)
- They were scored Level I on the Gross Motor Function Classification System (GMFCS).
- The subjects' age was from five to eleven years.
- They were at least 1-meter-tall and not less 20 Kg.
- They had to comprehend verbal commands.
- They were score 1 to 1+ based on Modified Ashworth' Scale.
Key exclusion criteria (7 listed)
- Contracture, deformity and/or tightness in upper or lower limbs.
- Botulinum toxin in the last year.
- Recent fracture.
- Vertigo or dizziness.
- Epilepsy.
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
balance.
Time frame: 1 day - one session
Biodex Balance System will be used to assess balance.
gross motor coordination.
Time frame: 1 day - one session
- Gross Motor - BOT -2 will be used to assess gross motor coordination.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Individual participant dataSharing planned: Undecided. Sharing Individual Patient Data (IPD) is often hindered by privacy concerns, data security risks, legal and ethical obligations, resource limitations, and data quality issues.
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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 Sinai 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 5 inclusion and 7 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 31 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alaa N Kora, PhD (01002701815, alaan.kora@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
balance. (time frame: 1 day - one session). 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 31 Jul 2024.