Upper Extremity Strength in Cerebral Palsy

Upper Extremity Strength in Children and Adolescents With and Without Unilateral 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.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy
• Intervention / Treatment: Other: reproducibility of upper extremity strength measurements

• Study Type: Observational
• Enrollment (Actual): 370

Contacts and Locations

Study Locations

• Netherlands
  • 's Hertogenbosch, Netherlands, 5200 ME
    • Tolbrug
  • Arnhem, Netherlands, 6813 GC
    • Klimmendaal
  • Breda, Netherlands, 4817 JW
    • Revant
  • Den Haag, Netherlands, 2543 SW
    • Sophie Revalidatie
  • Eindhoven, Netherlands, 5602 BJ
    • Libra Zorggroep
  • Leiden, Netherlands, 2333 AL
    • Rijnlands Revalidatie Centrum
  • Nijmegen, Netherlands, 6574 NA
    • St. Maartenskliniek
  • Venlo, Netherlands, 5912 BL
    • Viecuri Medical Centre
  • Limburg
    • Hoensbroek, Limburg, Netherlands, 6432CC
      • Adelante

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Spastic unilateral Cerebral Palsy and Healthy Controls

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inter-rater and test-retest reliability of HHD expressed as ICC value	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.	t1 (base-line) and t1 (2-3 weeks later)
Inter-rater and test-retest reliability of E-link expressed as ICC value	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.	t1 (base-line) and t1 (2-3 weeks later)
Inter-rater and test-retest reliability of functional strength measurements expressed as ICC value	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.	t1 (base-line) and t1 (2-3 weeks later)
Inter-rater and test-retest agreement of HHD expressed as Limits of Agreement	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.	t1 (base-line) and t1 (2-3 weeks later)
Inter-rater and test-retest agreement of E-Link expressed as Limits of Agreement	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.	t1 (base-line) and t1 (2-3 weeks later)
Inter-rater and test-retest agreement of functional measurements expressed as Limits of Agreement	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.	t1 (base-line) and t1 (2-3 weeks later)

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center
• Collaborators: Maastricht University; VieCuri Medical Centre; Adelante, Centre of Expertise in Rehabilitation and Audiology; Revant; Tolbrug; Libra Zorggroep
• Investigators: Principal Investigator: Yvonne JM Janssen-Potten, PhD, Adelante, Centre of Expertise in Rehabilitation and Audiology

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2014
• Primary Completion (Actual): March 19, 2018
• Study Completion (Actual): March 19, 2018

Study Registration Dates

• First Submitted: May 21, 2014
• First Submitted That Met QC Criteria: May 23, 2014
• First Posted (Estimate): May 26, 2014

Study Record Updates

• Last Update Posted (Actual): April 26, 2018
• Last Update Submitted That Met QC Criteria: April 25, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Cerebral Palsy; child; upper extremity; strength, reproducibility
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Cerebral Palsy; Paralysis
• Other Study ID Numbers: NL45430.068.13