Cerebral PalsyNCT05546164
Strength and Dexterity of Less Affected Hand of Hemiparetic Cerebral Palsy Children
An observational study of Cerebral Palsy, run by Cairo University at 1 site in Egypt.
Trial summary
The contralateral hand deficits are often masked by the complex clinical presentation of the more affected hand in children with spastic hemiparesis. Thus, intervention targeting the contralateral hand is not often a component of the child's rehabilitation plan of care. Read more about this study
- Who is it for?
- Ages 6 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Assessment of hand grip strength, Assessment of pinch strength and Assessment of upper limb dexterity
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2022to 30 Sep 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 6 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: This study will include 120 children of both gender with age from 6 years to 10 years
Who may be able to join
- Children will be recruited according to the following criteria:
- Age range between 6 and 10 years.
- Both sexes
- The degree of spasticity rang from grade 1 to 1+ according to Modified Ashworth scale (Appendix II).
- They can follow the order during the testing.
- Exclusion Criteria:Children will be excluded from the study if they had any of the following criteria;
Show all 11Show fewer
- Significant visual or auditory defect that may affect their performance.
- Previous orthopedic surgery for upper extremity.
- Injection with Botulinium toxin in the last 6 months.
- Structural deformities in any joint or bone of the upper limbs.
- Practicing any form of sports.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Strength and Dexterity of Less Affected Hand of Hemiparetic Cerebral Palsy Children: A Comparison Study With Normal Peers
The contralateral hand deficits are often masked by the complex clinical presentation of the more affected hand in children with spastic hemiparesis. Thus, intervention targeting the contralateral hand is not often a component of the child's rehabilitation plan of care. The presence of bilateral hand deficits, even if subtle in the contralateral hand, may limit the transfer of unimanual gains following rehabilitation to bimanual activities of daily living tasks. However, conservation of upper-limb function of the less-affected side is highly important for individuals with hemiparesis, because this side is often employed as a compensatory 'tool' in performing activities of daily living . Therefore, the current study will be conducted to determine and compare the motor abilities of the less affected hand of children with hemiparesis.
Read the detailed description
An impairment of the less affected hand of hemiparetic cerebral palsy children can be detrimental to the development of bimanual skills. It would be beneficial to identify and quantify the severity of any impairment of the less affected hand of hemiparetic cerebral palsy children. Hemiparetic cerebral palsy may present with substantial deficits in hand function, because bimanual activities involve the ability to use the affected and contralateral hands together for grasp and stabilization. Several authors have evaluated bimanual involvement in cerebral palsy but these studies have not compared the contralateral hand with norms. The less affected hand is widely regarded as "normal" or "unaffected" and is consequently rarely evaluated.
Several authors have reported incidental findings of subtle deficits in the less affected extremity, noted that hemiparetic children "also presented motor impairments in their non-paretic hand, especially in dexterity.
The purpose of this study is to assess the grip ,pinch strength and dexterity of less affected hand of hemiparetic cerebral palsy children and compare with dominant hand of normal peers
- Conditions
- Cerebral Palsy
- Being tested
- Assessment of hand grip strength, Assessment of pinch strength, Assessment of upper limb dexterity
- Keywords
- Cerebral Palsy, Unilateral cerebral palsy, grip strength, pinch strength, upper limb dexterity
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of hand grip strengthOther
Assessment of hand grip strength
Assessment of pinch strengthOther
Assessment of pinch strength
Assessment of upper limb dexterityOther
Assessment of upper limb dexterity
| Study group | Role | What they receive |
|---|---|---|
| Hemiparetic group | This group will contains 60 children with hemiparesis Receives: Other: Assessment of hand grip strength; Other: Assessment of pinch strength; Other: Assessment of upper limb dexterity | |
| Normal group | This group will contains 60 children with normal children Receives: Other: Assessment of hand grip strength; Other: Assessment of pinch strength; Other: Assessment of upper limb dexterity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hand grip strength
Hand dynamometer will be used to measure grip strength. It is a reliable tool, by measuring the amount of pressure applied to the compressible bulb-shaped rubber handle (Innes, 1999).The child sit in chair with armrest, suitable back support, feet flat on the floor, shoulder adducted to side, elbow flexed to 90 degree and forearm in neutral position then teach the child how to apply pressure on bulb through grip or pinch pressure for 3 times and their mean was calculated.
Measured: from October 2022 to September 2023
Hand pinch strength
Hand dynamometer will be used to measure pinch strength. It is a reliable tool, by measuring the amount of pressure applied to the compressible bulb-shaped rubber handle (Innes, 1999).The child sit in chair with armrest, suitable back support, feet flat on the floor, shoulder adducted to side, elbow flexed to 90 degree and forearm in neutral position then teach the child how to apply pressure on bulb through grip or pinch pressure for 3 times and their mean was calculated.
Measured: from October 2022 to September 2023
upper limb dexterity
Functional dexterity test will be used for assessment of fine motor dexterity. it is a timed pegboard test that provides objective assessment of in-hand manipulation and tripod pinch, .It consists of 16 cylindrical pegs arranged on a peg board in 4 rows of 4 pegs. Participants are instructed to pick up each peg, turn it over in their hand while refraining from supinating or touching the table with the peg, and re-insert it into the pegboard as quickly as possible, beginning with the top row and proceeding in a zigzag fashion through all 4 rows. One complete practice trial is performed to allow the child to learn the task, and the second trial is timed. The time taken to complete the test is measured with a stopwatch..
Measured: from October 2022 to September 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2022
- Study start1 Oct 2022
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
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
- Other
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Ahmed Mohamed Hassan, Cairo University
- Investigators
- Emam EL-Negamy, PhD, Study chair, Cairo UniversityAmira Mahmoud, PhD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05546164
- Sponsor's protocol ID
- No: p.T. R E C /012 /003789
- Status last verified
- Nov 2023
- First submitted
- 15 Sep 2022
- Last updated
- 18 Nov 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 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Strength and Dexterity of Less Affected Hand of Hemiparetic Cerebral Palsy Children: A Comparison Study With Normal Peers
- ClinicalTrials.gov ID
- NCT05546164
- Acronym / sponsor ID
- No: p.T. R E C /012 /003789
- Conditions
- Cerebral Palsy
- Keywords
- Cerebral Palsy, Unilateral cerebral palsy, grip strength, pinch strength, upper limb dexterity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 19 Sep 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.
The contralateral hand deficits are often masked by the complex clinical presentation of the more affected hand in children with spastic hemiparesis. Thus, intervention targeting the contralateral hand is not often a component of the child's rehabilitation plan of care. The presence of bilateral hand deficits, even if subtle in the contralateral hand, may limit the transfer of unimanual gains following rehabilitation to bimanual activities of daily living tasks. However, conservation of upper-limb function of the less-affected side is highly important for individuals with hemiparesis, because this side is often employed as a compensatory 'tool' in performing activities of daily living . Therefore, the current study will be conducted to determine and compare the motor abilities of the less affected hand of children with hemiparesis.
Detailed description
An impairment of the less affected hand of hemiparetic cerebral palsy children can be detrimental to the development of bimanual skills. It would be beneficial to identify and quantify the severity of any impairment of the less affected hand of hemiparetic cerebral palsy children. Hemiparetic cerebral palsy may present with substantial deficits in hand function, because bimanual activities involve the ability to use the affected and contralateral hands together for grasp and stabilization. Several authors have evaluated bimanual involvement in cerebral palsy but these studies have not compared the contralateral hand with norms. The less affected hand is widely regarded as "normal" or "unaffected" and is consequently rarely evaluated.
Several authors have reported incidental findings of subtle deficits in the less affected extremity, noted that hemiparetic children "also presented motor impairments in their non-paretic hand, especially in dexterity.
The purpose of this study is to assess the grip ,pinch strength and dexterity of less affected hand of hemiparetic cerebral palsy children and compare with dominant hand of normal peers
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hemiparetic group | – | Other: Assessment of hand grip strength, Other: Assessment of pinch strength, Other: Assessment of upper limb dexterityThis group will contains 60 children with hemiparesis |
| Normal group | – | Other: Assessment of hand grip strength, Other: Assessment of pinch strength, Other: Assessment of upper limb dexterityThis group will contains 60 children with normal children |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- This study will include 120 children of both gender with age from 6 years to 10 years
Key inclusion criteria (11 listed)
- Children will be recruited according to the following criteria:
- Age range between 6 and 10 years.
- Both sexes
- The degree of spasticity rang from grade 1 to 1+ according to Modified Ashworth scale (Appendix II).
- They can follow the order during the testing.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Assessment of hand grip strengthAssessment of hand grip strength | Other | Hemiparetic group, Normal group |
| Assessment of pinch strengthAssessment of pinch strength | Other | Hemiparetic group, Normal group |
| Assessment of upper limb dexterityAssessment of upper limb dexterity | Other | Hemiparetic group, Normal group |
Primary outcome
Hand grip strength
Time frame: from October 2022 to September 2023
Hand dynamometer will be used to measure grip strength. It is a reliable tool, by measuring the amount of pressure applied to the compressible bulb-shaped rubber handle (Innes, 1999).The child sit in chair with armrest, suitable back support, feet flat on the floor, shoulder adducted to side, elbow flexed to 90 degree and forearm in neutral position then teach the child how to apply pressure on bulb through grip or pinch pressure for 3 times and their mean was calculated.
Hand pinch strength
Time frame: from October 2022 to September 2023
Hand dynamometer will be used to measure pinch strength. It is a reliable tool, by measuring the amount of pressure applied to the compressible bulb-shaped rubber handle (Innes, 1999).The child sit in chair with armrest, suitable back support, feet flat on the floor, shoulder adducted to side, elbow flexed to 90 degree and forearm in neutral position then teach the child how to apply pressure on bulb through grip or pinch pressure for 3 times and their mean was calculated.
upper limb dexterity
Time frame: from October 2022 to September 2023
Functional dexterity test will be used for assessment of fine motor dexterity. it is a timed pegboard test that provides objective assessment of in-hand manipulation and tripod pinch, .It consists of 16 cylindrical pegs arranged on a peg board in 4 rows of 4 pegs. Participants are instructed to pick up each peg, turn it over in their hand while refraining from supinating or touching the table with the peg, and re-insert it into the pegboard as quickly as possible, beginning with the top row and proceeding in a zigzag fashion through all 4 rows. One complete practice trial is performed to allow the child to learn the task, and the second trial is timed. The time taken to complete the test is measured with a stopwatch..
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 18 Nov 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.
Emam EL-Negamy, PhD study chair
Cairo University
Amira Mahmoud, PhD 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 11 inclusion and 0 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 18 Nov 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?
Hand grip strength (time frame: from October 2022 to September 2023). 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 18 Nov 2023.