Clinical trial NCT02146989: Upper Extremity Strength in Cerebral Palsy
Official title: Upper Extremity Strength in Children and Adolescents With and Without Unilateral Cerebral Palsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy
Keywords: Cerebral Palsy
child
upper extremity
strength, reproducibility
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Maastricht University
name: Adelante, Centre of Expertise in Rehabilitation and Audiology
name: Revant
name: Tolbrug
name: Libra Zorggroep
name: VieCuri Medical Centre
First posted: 2014-05-26
Enrollment: 370
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Spastic unilateral Cerebral Palsy and Healthy Controls

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.


Eligibility 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

Primary outcomes:
measure: Inter-rater and test-retest reliability of HHD expressed as ICC value
timeFrame: t1 (base-line) and t1 (2-3 weeks later)
measure: Inter-rater and test-retest reliability of E-link expressed as ICC value
timeFrame: t1 (base-line) and t1 (2-3 weeks later)
measure: Inter-rater and test-retest reliability of functional strength measurements expressed as ICC value
timeFrame: t1 (base-line) and t1 (2-3 weeks later)
measure: Inter-rater and test-retest agreement of HHD expressed as Limits of Agreement
timeFrame: t1 (base-line) and t1 (2-3 weeks later)
measure: Inter-rater and test-retest agreement of E-Link expressed as Limits of Agreement
timeFrame: t1 (base-line) and t1 (2-3 weeks later)
measure: Inter-rater and test-retest agreement of functional measurements expressed as Limits of Agreement
timeFrame: t1 (base-line) and t1 (2-3 weeks later)
Secondary outcomes:
Other outcomes:
Locations:
city: Hoensbroek
country: Netherlands
facility: Adelante
state: Limburg
city: 's Hertogenbosch
country: Netherlands
facility: Tolbrug
city: Arnhem
country: Netherlands
facility: Klimmendaal
city: Breda
country: Netherlands
facility: Revant
city: Den Haag
country: Netherlands
facility: Sophie Revalidatie
city: Eindhoven
country: Netherlands
facility: Libra Zorggroep
city: Leiden
country: Netherlands
facility: Rijnlands Revalidatie Centrum
city: Nijmegen
country: Netherlands
facility: St. Maartenskliniek
city: Venlo
country: Netherlands
facility: Viecuri Medical Centre
Study officials:
affiliation: Adelante, Centre of Expertise in Rehabilitation and Audiology
name: Yvonne JM Janssen-Potten, PhD
role: PRINCIPAL_INVESTIGATOR
References: