Upper Extremity Strength in Cerebral Palsy

NCT ID: NCT02146989

Last Updated: 2018-04-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

370 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-06-30

Study Completion Date

2018-03-19

Brief Summary

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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.

Detailed Description

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Conditions

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Cerebral Palsy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

reproducibility of upper extremity strength measurements

Intervention Type OTHER

inter-rater reliability and test-retest reliability

Healthy controls

Children and adolescents without Cerebral Palsy

reproducibility of upper extremity strength measurements

Intervention Type OTHER

inter-rater reliability and test-retest reliability

Interventions

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reproducibility of upper extremity strength measurements

inter-rater reliability and test-retest reliability

Intervention Type OTHER

Other Intervention Names

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Hand Held Dynamometry E-link system functional strength measurements

Eligibility Criteria

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Inclusion Criteria

* 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


* children attending primary or secondary school
* agd 7 to 18 years

Exclusion Criteria

* 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


* muscle disease
* lesion, fracture or cast \< 6 months
Minimum Eligible Age

7 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Maastricht University

OTHER

Sponsor Role collaborator

Adelante, Centre of Expertise in Rehabilitation and Audiology

OTHER

Sponsor Role collaborator

Revant

UNKNOWN

Sponsor Role collaborator

Tolbrug

UNKNOWN

Sponsor Role collaborator

Libra Zorggroep

UNKNOWN

Sponsor Role collaborator

VieCuri Medical Centre

OTHER

Sponsor Role collaborator

Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yvonne JM Janssen-Potten, PhD

Role: PRINCIPAL_INVESTIGATOR

Adelante, Centre of Expertise in Rehabilitation and Audiology

Locations

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Adelante

Hoensbroek, Limburg, Netherlands

Site Status

Tolbrug

's-Hertogenbosch, , Netherlands

Site Status

Klimmendaal

Arnhem, , Netherlands

Site Status

Revant

Breda, , Netherlands

Site Status

Libra Zorggroep

Eindhoven, , Netherlands

Site Status

Rijnlands Revalidatie Centrum

Leiden, , Netherlands

Site Status

St. Maartenskliniek

Nijmegen, , Netherlands

Site Status

Sophie Revalidatie

The Hague, , Netherlands

Site Status

Viecuri Medical Centre

Venlo, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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NL45430.068.13

Identifier Type: -

Identifier Source: org_study_id

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