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Trial record 85 of 10357 for:    strength

Upper Extremity Strength in Cerebral Palsy

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ClinicalTrials.gov Identifier: NCT02146989
Recruitment Status : Completed
First Posted : May 26, 2014
Last Update Posted : April 26, 2018
Sponsor:
Collaborators:
Maastricht University
Adelante, Centre of Expertise in Rehabilitation and Audiology
Revant
Tolbrug
Libra Zorggroep
VieCuri Medical Centre
Information provided by (Responsible Party):
Maastricht University Medical Center

Brief Summary:

Rationale:

Children with Cerebral Palsy (CP) experience limitations in motor activities and participation in the community, predominantly caused by impairments in muscle function. Aside from abnormal posturing due to spasticity, muscle weakness can significantly contribute to impaired muscle function and there is increasing evidence that muscle weakness significantly impairs upper limb motor function and ability to perform manual tasks in children with CP. Studies in the last decade have shown that muscle weakness, not spasticity, is the greatest limiting factor of motor function in children with CP. Furthermore, there is increasing evidence that the strength in the upper extremities of children with CP is less compared to their typically developing peers (TDP). A systematic review focused on the psychometric properties of strength measurement instruments has shown that the number of studies investigating psychometric properties of strength measurement instruments is limited and that the methodological quality of these studies is low.

Aim:

The present study aims to investigate the reproducibility of the following three isometric strength measurements in the upper extremity of children and adolescents with unilateral CP as well as in TDP: Hand Held Dynamometry (HHD), pinch and grip strength using the E-link system and functional strength. To study to which extent upper extremity strength, both in the affected side and the non-affected side, differs from the strength in the upper extremities of TDP, these measurements will also be performed by children without neurological problems.

Study Design:

A cross-sectional study in which the reproducibility of three strength measurement instruments, i.e. HHD, E-link and Functional strength, will be investigated in children and adolescents with unilateral CP and TDP.

Population:

Children with unilateral spastic CP (with perinatal acquired hypoxic ischemic incidents), aged 7 to 18 years, Manual Ability Classification System (MACS) levels I-III, who are mentally able to perform the measurements will be included and TDP.

Outcome measures:

The most important psychometric property in strength measurement instruments is reproducibility. Reproducibility will be investigated using the following factors: Intraclass Correlation Coefficient (ICC), Limits of Agreement (LOA), Standard Error of Measurement (SEM) and the Smallest Detectable Difference (SDD). Reference values will be determined using the Generalised Additive Models for Location, Scale, and Shape (GAMLSS) method.


Condition or disease Intervention/treatment
Cerebral Palsy Other: reproducibility of upper extremity strength measurements

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Study Type : Observational
Actual Enrollment : 370 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Upper Extremity Strength in Children and Adolescents With and Without Unilateral Cerebral Palsy
Actual Study Start Date : June 2014
Actual Primary Completion Date : March 19, 2018
Actual Study Completion Date : March 19, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Cerebral Palsy
Children and adolescents with spastic unilateral Cerebral Palsy (with perinatal acquired hypoxic ischemic incidents), aged 7 to 18 years, MACS levels I-III.
Other: reproducibility of upper extremity strength measurements
inter-rater reliability and test-retest reliability
Other Names:
  • Hand Held Dynamometry
  • E-link system
  • functional strength measurements

Healthy controls
Children and adolescents without Cerebral Palsy
Other: reproducibility of upper extremity strength measurements
inter-rater reliability and test-retest reliability
Other Names:
  • Hand Held Dynamometry
  • E-link system
  • functional strength measurements




Primary Outcome Measures :
  1. Inter-rater and test-retest reliability of HHD expressed as ICC value [ Time Frame: t1 (base-line) and t1 (2-3 weeks later) ]
    The intraclass correlation coefficient (ICC) is commonly used in the assessment of consistency or reproducibility of quantitative measurements made by different observers measuring the same quantity.

  2. Inter-rater and test-retest reliability of E-link expressed as ICC value [ Time Frame: t1 (base-line) and t1 (2-3 weeks later) ]
    The intraclass correlation coefficient (ICC) is commonly used in the assessment of consistency or reproducibility of quantitative measurements made by different observers measuring the same quantity.

  3. 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) ]
    The intraclass correlation coefficient (ICC) is commonly used in the assessment of consistency or reproducibility of quantitative measurements made by different observers measuring the same quantity.

  4. Inter-rater and test-retest agreement of HHD expressed as Limits of Agreement [ Time Frame: t1 (base-line) and t1 (2-3 weeks later) ]
    The limits of agreement (LOA) provide insight into how much random variation may be influencing the ratings. If the raters tend to agree, the differences between the raters' observations will be near zero. If one rater is usually higher or lower than the other by a consistent amount, the bias (mean of differences) will be different from zero. If the raters tend to disagree, but without a consistent pattern of one rating higher than the other, the mean will be near zero. Confidence limits (usually 95%) can be calculated for both the bias and each of the limits of agreement.

  5. 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) ]
    The limits of agreement (LOA) provide insight into how much random variation may be influencing the ratings. If the raters tend to agree, the differences between the raters' observations will be near zero. If one rater is usually higher or lower than the other by a consistent amount, the bias (mean of differences) will be different from zero. If the raters tend to disagree, but without a consistent pattern of one rating higher than the other, the mean will be near zero. Confidence limits (usually 95%) can be calculated for both the bias and each of the limits of agreement.

  6. 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) ]
    The limits of agreement (LOA) provide insight into how much random variation may be influencing the ratings. If the raters tend to agree, the differences between the raters' observations will be near zero. If one rater is usually higher or lower than the other by a consistent amount, the bias (mean of differences) will be different from zero. If the raters tend to disagree, but without a consistent pattern of one rating higher than the other, the mean will be near zero. Confidence limits (usually 95%) can be calculated for both the bias and each of the limits of agreement.



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Ages Eligible for Study:   7 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Spastic unilateral Cerebral Palsy and Healthy Controls
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02146989


Locations
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Netherlands
Adelante
Hoensbroek, Limburg, Netherlands, 6432CC
Tolbrug
's Hertogenbosch, Netherlands, 5200 ME
Klimmendaal
Arnhem, Netherlands, 6813 GC
Revant
Breda, Netherlands, 4817 JW
Sophie Revalidatie
Den Haag, Netherlands, 2543 SW
Libra Zorggroep
Eindhoven, Netherlands, 5602 BJ
Rijnlands Revalidatie Centrum
Leiden, Netherlands, 2333 AL
St. Maartenskliniek
Nijmegen, Netherlands, 6574 NA
Viecuri Medical Centre
Venlo, Netherlands, 5912 BL
Sponsors and Collaborators
Maastricht University Medical Center
Maastricht University
Adelante, Centre of Expertise in Rehabilitation and Audiology
Revant
Tolbrug
Libra Zorggroep
VieCuri Medical Centre
Investigators
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Principal Investigator: Yvonne JM Janssen-Potten, PhD Adelante, Centre of Expertise in Rehabilitation and Audiology

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Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT02146989     History of Changes
Other Study ID Numbers: NL45430.068.13
First Posted: May 26, 2014    Key Record Dates
Last Update Posted: April 26, 2018
Last Verified: April 2018
Keywords provided by Maastricht University Medical Center:
Cerebral Palsy
child
upper extremity
strength, reproducibility
Additional relevant MeSH terms:
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Paralysis
Cerebral Palsy
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases