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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02146989 |
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Date of registration:
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21/05/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Upper Extremity Strength in Cerebral Palsy
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Scientific title:
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Upper Extremity Strength in Children and Adolescents With and Without Unilateral Cerebral Palsy |
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Date of first enrolment:
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June 2014 |
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Target sample size:
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370 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02146989 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Netherlands
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Contacts
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Name:
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Yvonne JM Janssen-Potten, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Adelante, Centre of Expertise in Rehabilitation and Audiology |
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Key inclusion & exclusion criteria
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Inclusion Criteria CP:
- Children with unilateral spastic CP (with perinatal acquired hypoxic ischemic
incidents),
- aged 7 to 18 years,
- MACS levels I-III,
- mentally able to perform the measurements
Inclusion criteria Healthy Controls:
- children attending primary or secondary school
- agd 7 to 18 years
Exclusion Criteria CP:
- Surgical intervention <6 months
- Botulinum Toxin A treatment in the upper extremity < 6 months
- contractures in the upper extremity that might interfere with task performance
Exclusion criteria Healthy Controls:
- muscle disease
- lesion, fracture or cast < 6 months
Age minimum:
7 Years
Age maximum:
18 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Cerebral Palsy
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Intervention(s)
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Other: reproducibility of upper extremity strength measurements
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Primary Outcome(s)
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Inter-rater and test-retest reliability of E-link expressed as ICC value
[Time Frame: t1 (base-line) and t1 (2-3 weeks later)]
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Inter-rater and test-retest reliability of HHD expressed as ICC value
[Time Frame: t1 (base-line) and t1 (2-3 weeks later)]
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Inter-rater and test-retest agreement of E-Link expressed as Limits of Agreement
[Time Frame: t1 (base-line) and t1 (2-3 weeks later)]
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Inter-rater and test-retest agreement of functional measurements expressed as Limits of Agreement
[Time Frame: t1 (base-line) and t1 (2-3 weeks later)]
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Inter-rater and test-retest agreement of HHD expressed as Limits of Agreement
[Time Frame: t1 (base-line) and t1 (2-3 weeks later)]
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Inter-rater and test-retest reliability of functional strength measurements expressed as ICC value
[Time Frame: t1 (base-line) and t1 (2-3 weeks later)]
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Secondary ID(s)
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NL45430.068.13
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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