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Completed

NCT Number: NCT02146989

Upper Extremity Strength in Cerebral Palsy

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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

7 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Adelante, Hoensbroek, Limburg, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

reproducibility of upper extremity strength measurements

Other

inter-rater reliability and test-retest reliability

Other names: Hand Held Dynamometry, E-link system, functional strength measurements

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • Adelante, Centre of Expertise in Rehabilitation and Audiology
  • Libra Zorggroep
  • Maastricht University
  • Revant
  • Tolbrug
  • VieCuri Medical Centre

Registry information

Official study title

Upper Extremity Strength in Children and Adolescents With and Without Unilateral Cerebral Palsy

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
May 26, 2014
Registry last updated
Apr 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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