Cerebral PalsyHemiparesisNCT04644588
Scapular Alignment and Upper Limb Function in Children With Cerebral Palsy
An observational study of Cerebral Palsy, run by Cairo University at 1 site in Egypt.
Trial summary
Purpose: To determine the effect of scapular alignment on upper limb function in hemiparetic children and to find relation between scapular alignment of the affected, less affected limb and the upper limb function in children with spastic hemiparesis Subjects: Forty children with spastic hemiparetic cerebral palsy… Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Children with hemiparetic cerebral palsy being assessed for scapular alignment and upper limb function.
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2020to 30 Jan 2021
- 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 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Study population: Forty children with spastic hemiplegic CP, from both genders, were included in this study. They were selected from Outpatient Clinic of Faculty of Physical Therapy, Cairo University. The age of the selected children was ranging from 3 to 6 years old. They were able to follow instructions and understand commands.Degree of spasticity is ranging from 1 to 1+ according to modified Ashworth scale.
Who may be able to join
- The age of the selected children was ranging from 3 to 6 years old .
- Both genders were included.
- They were able to follow instructions and understand commands.
- Degree of spasticity is ranging from 1 to 1+ according to modified Ashworth scale.
Who cannot join
- Upper limb surgery in the last 12 months.
- Children which had contracture, fracture, and fixed deformities in the upper limb.
- Children with muscleoskletal abnormalities as fixed back deformities.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation Between Scapular Alignment and Upper Limb Function in Children With Hemiparetic Cerebral Palsy
Purpose: To determine the effect of scapular alignment on upper limb function in hemiparetic children and to find relation between scapular alignment of the affected, less affected limb and the upper limb function in children with spastic hemiparesis Subjects: Forty children with spastic hemiparetic cerebral palsy, from both genders, were included in this study. They were selected from Outpatient Clinic of Faculty of Physical Therapy, Cairo University. The age of the selected children was ranging from 3 to 6 years old. Degree of spasticity is ranging from 1 to 1+ according to modified Ashworth scale.
Methods: Forty children with spastic hemiparetic cerebral palsy were assessed for scapular alignment using Postural zone software and for upper limb function using pediatric arm function test.
Read the detailed description
Subjects:
Forty children with spastic hemiplegic CP, from both genders, were included in this study. They were selected from Outpatient Clinic of Faculty of Physical Therapy, Cairo University.
Inclusion criteria:
Children were enrolled in this study according to the following criteria:
- The age of the selected children was ranging from 3 to 6 years old .
- Both genders were included.
- They were able to follow instructions and understand commands.
- Degree of spasticity is ranging from 1 to 1+ according to modified Ashworth scale.
- Postural zone software was assess scapular alignment and pediatric arm function test was assess upper arm function .
Exclusion criteria:
The child was excluded from the study if he / she has one or more of the following:
- Upper limb surgery in the last 12 months.
- Children which had contracture, fracture, and fixed deformities in the upper limb.
- Children with muscleoskletal abnormalities as fixed back deformities.
Methods:
Forty children with spastic hemiparetic cerebral palsy were assessed for scapular alignment using Postural zone software and for upper limb function using pediatric arm function test.
- Conditions
- Cerebral Palsy
- Being tested
- Children with hemiparetic cerebral palsy being assessed for scapular alignment and upper limb function.
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Children with hemiparetic cerebral palsy being assessed for scapular alignment and upper limb function.Diagnostic test
Also called Children being assessed for scapular alignment and upper limb function.
Children with hemiparetic cerebral palsy being assessed for scapular alignment and upper limb function.
| Study group | Role | What they receive |
|---|---|---|
| Children being assessed for scapular alignment and upper limb function. | Children with hemiparetic cerebral palsy being assessed for scapular alignment and hand function using postural zone software to assess scapular alignment and pediatric arm function test toassess upper limb function . Receives: Diagnostic Test: Children with hemiparetic cerebral palsy being assessed for scapular alignment and upper limb function. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Children being assessed for scapular alignment.
Children being assessed for scapular alignment using postural zone software.
Measured: baseline ( enrolment)
Number of Children being assessed for upper limb function.
Children being assessed for upper limb function using pediatric arm function test.
Measured: baseline ( enrolment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2020
- Study start1 Feb 2020
- Primary completion6 Nov 2020
- Study completion30 Jan 2021
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 only
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Elsayed Abbass, Cairo University
- Investigators
- Mai Abbass, Ph.D., Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04644588
- Sponsor's protocol ID
- REC\012\002554
- Acronym
- Hemiparesis
- Status last verified
- Feb 2021
- First submitted
- 20 Nov 2020
- Last updated
- 26 Feb 2021
- 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 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Scapular Alignment and Upper Limb Function in Children With Hemiparetic Cerebral Palsy
- ClinicalTrials.gov ID
- NCT04644588
- Acronym / sponsor ID
- Hemiparesis / REC\012\002554
- Conditions
- Cerebral Palsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 6 Nov 2020 (actual)
- Study completion
- 30 Jan 2021 (actual)
- First posted
- 25 Nov 2020 (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 determine the effect of scapular alignment on upper limb function in hemiparetic children and to find relation between scapular alignment of the affected, less affected limb and the upper limb function in children with spastic hemiparesis Subjects: Forty children with spastic hemiparetic cerebral palsy, from both genders, were included in this study. They were selected from Outpatient Clinic of Faculty of Physical Therapy, Cairo University. The age of the selected children was ranging from 3 to 6 years old. Degree of spasticity is ranging from 1 to 1+ according to modified Ashworth scale.
Methods: Forty children with spastic hemiparetic cerebral palsy were assessed for scapular alignment using Postural zone software and for upper limb function using pediatric arm function test.
Detailed description
Subjects:
Forty children with spastic hemiplegic CP, from both genders, were included in this study. They were selected from Outpatient Clinic of Faculty of Physical Therapy, Cairo University.
Inclusion criteria:
Children were enrolled in this study according to the following criteria:
- The age of the selected children was ranging from 3 to 6 years old .
- Both genders were included.
- They were able to follow instructions and understand commands.
- Degree of spasticity is ranging from 1 to 1+ according to modified Ashworth scale.
- Postural zone software was assess scapular alignment and pediatric arm function test was assess upper arm function .
Exclusion criteria:
The child was excluded from the study if he / she has one or more of the following:
- Upper limb surgery in the last 12 months.
- Children which had contracture, fracture, and fixed deformities in the upper limb.
- Children with muscleoskletal abnormalities as fixed back deformities.
Methods:
Forty children with spastic hemiparetic cerebral palsy were assessed for scapular alignment using Postural zone software and for upper limb function using pediatric arm function test.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children being assessed for scapular alignment and upper limb function. | – | Diagnostic Test: Children with hemiparetic cerebral palsy being assessed for scapular alignment and upper limb function.Children with hemiparetic cerebral palsy being assessed for scapular alignment and hand function using postural zone software to assess scapular alignment and pediatric arm function test toassess upper limb function . |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Forty children with spastic hemiplegic CP, from both genders, were included in this study. They were selected from Outpatient Clinic of Faculty of Physical Therapy, Cairo University. The age of the selected children was ranging from 3 to 6 years old. They were able to follow instructions and understand commands.Degree of spasticity is ranging from 1 to 1+ according to modified Ashworth scale.
Key inclusion criteria (4 listed)
- The age of the selected children was ranging from 3 to 6 years old .
- Both genders were included.
- They were able to follow instructions and understand commands.
- Degree of spasticity is ranging from 1 to 1+ according to modified Ashworth scale.
Key exclusion criteria (3 listed)
- Upper limb surgery in the last 12 months.
- Children which had contracture, fracture, and fixed deformities in the upper limb.
- Children with muscleoskletal abnormalities as fixed back deformities.
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 |
|---|---|---|
| Children with hemiparetic cerebral palsy being assessed for scapular alignment and upper limb function.Also: Children being assessed for scapular alignment and upper limb function.Children with hemiparetic cerebral palsy being assessed for scapular alignment and upper limb function. | Diagnostic test | Children being assessed for scapular alignment and upper limb function. |
Primary outcome
Number of Children being assessed for scapular alignment.
Time frame: baseline ( enrolment)
Children being assessed for scapular alignment using postural zone software.
Number of Children being assessed for upper limb function.
Time frame: baseline ( enrolment)
Children being assessed for upper limb function using pediatric arm function test.
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 26 Feb 2021.
- 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.
Mai Abbass, Ph.D. study director
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 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 4 inclusion and 3 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 26 Feb 2021. 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?
Number of Children being assessed for scapular alignment. (time frame: baseline ( enrolment)). 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 26 Feb 2021.