HemiplegiaNCT05614167
Relationship Between Isometric Muscle Strength and Gross Motor Function in Children With Unilateral Cerebral Palsy
An observational study of Hemiplegia and Cerebral Palsy, run by Badr University at 1 site in Egypt.
Trial summary
Muscle strength can be defined as the ability of skeletal muscle to develop force for the purpose of providing stability and mobility within the musculoskeletal system, so that functional movement can take place. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Hemiplegia, Cerebral Palsy
- What is being tested?
- correlation
- How many people
- 97 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Nov 2022to 12 Feb 2023
- How long will I take part?
- 3 Months
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Study population: Muscle weakness was found in children with CP, increasing with severity of gross motor function, approximately 50% of the predicted muscle strength was needed to be able to walk without aids.
Who may be able to join
- Their age between 6 and 12 years old.
- Grade 1and 2 according to the Modified Ashworth scale (RW and Smith, 1987).
- They could walk with limitation or holding on according to GMFCS (level I, II) (Palisano et al., 1997).
- They were able to understand and follow verbal instructions.
Who cannot join
- Children with any visual or auditory problems.
- Children with any surgical interference in the lower limb.
- Children with any structural deformities in joints and bones of lower limbs.
- Children with any special medications affecting muscle functions (anti-spastic drugs).
- Children who suffer from other diseases or associated disorders that interfered with physical activity.
Trial locations and contacts
1 site in 1 country.
About this study
Muscle strength can be defined as the ability of skeletal muscle to develop force for the purpose of providing stability and mobility within the musculoskeletal system, so that functional movement can take place.
Read the detailed description
Cerebral palsy describes a group of disorders of the development of movement and posture, causing activity limitation, that are attributed to non-progressive disturbances that occurred in the developing fatal or infant brain. The motor disorders of cerebral palsy are often accompanied by disturbances of sensation, cognition, communication, perception, and/or behaviour, and/or by a seizure disorder
The development and changes in motor function, both natural and with therapy, can be assessed using the Gross Motor Function Measure (GMFM) created for children with CP
- Conditions
- Hemiplegia, Cerebral Palsy
- Being tested
- correlation
- Keywords
- Hemiplegia, Cerebral Palsy, muscle stength, gmfm
- Medical subject headings
- Hemiplegia, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
correlationOther
A total of 97 children with CP between the ages of six and 12 years participated in the study. Muscle strength was measured with a handheld dynamometer. Motor function in children with CP was classified with the Gross Motor Function Classification System (GMFCS), graded with the Gross Motor Function Measure (GMFM)
What is being measured
The primary outcome is the main question the study is designed to answer.
Gross motor function measure
standing and walking domain
Measured: 3 months
Isometric muscle strength
a handheld dynamometer
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start7 Nov 2022
- Primary completion12 Jan 2023
- Study completion12 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemiplegiaStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 97 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Badr University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omnya Samy Abdallah Ghoneim, Badr University
- Investigators
- Omnya samy, PHD, Principal investigator, lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05614167
- Sponsor's protocol ID
- Omnya3
- Status last verified
- Apr 2023
- First submitted
- 5 Nov 2022
- Last updated
- 11 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: private
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Isometric Muscle Strength and Gross Motor Function in Children With Unilateral Cerebral Palsy
- ClinicalTrials.gov ID
- NCT05614167
- Acronym / sponsor ID
- Omnya3
- Conditions
- Hemiplegia, Cerebral Palsy
- Keywords
- Hemiplegia, Cerebral Palsy, muscle stength, gmfm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Badr UniversityUniversity, hospital or other
- Study start
- 7 Nov 2022 (actual)
- Primary completion
- 12 Jan 2023 (actual)
- Study completion
- 12 Feb 2023 (actual)
- First posted
- 14 Nov 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.
Muscle strength can be defined as the ability of skeletal muscle to develop force for the purpose of providing stability and mobility within the musculoskeletal system, so that functional movement can take place.
Detailed description
Cerebral palsy describes a group of disorders of the development of movement and posture, causing activity limitation, that are attributed to non-progressive disturbances that occurred in the developing fatal or infant brain. The motor disorders of cerebral palsy are often accompanied by disturbances of sensation, cognition, communication, perception, and/or behaviour, and/or by a seizure disorder
The development and changes in motor function, both natural and with therapy, can be assessed using the Gross Motor Function Measure (GMFM) created for children with CP
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Muscle weakness was found in children with CP, increasing with severity of gross motor function, approximately 50% of the predicted muscle strength was needed to be able to walk without aids.
Key inclusion criteria (4 listed)
- Their age between 6 and 12 years old.
- Grade 1and 2 according to the Modified Ashworth scale (RW and Smith, 1987).
- They could walk with limitation or holding on according to GMFCS (level I, II) (Palisano et al., 1997).
- They were able to understand and follow verbal instructions.
Key exclusion criteria (5 listed)
- Children with any visual or auditory problems.
- Children with any surgical interference in the lower limb.
- Children with any structural deformities in joints and bones of lower limbs.
- Children with any special medications affecting muscle functions (anti-spastic drugs).
- Children who suffer from other diseases or associated disorders that interfered with physical activity.
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 |
|---|---|---|
| correlationA total of 97 children with CP between the ages of six and 12 years participated in the study. Muscle strength was measured with a handheld dynamometer. Motor function in children with CP was classified with the Gross Motor Function Classification System (GMFCS), graded with the Gross Motor Function Measure (GMFM) | Other | – |
Primary outcome
Gross motor function measure
Time frame: 3 months
standing and walking domain
Isometric muscle strength
Time frame: 3 months
a handheld dynamometer
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 11 Apr 2023.
- Individual participant dataSharing planned: No. private
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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.
Omnya samy, PHD principal investigator
lecturer
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 Hemiplegia and Cerebral Palsy, run by Badr 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 4 inclusion and 5 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 11 Apr 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?
Gross motor function measure (time frame: 3 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 11 Apr 2023.