Upper Extremity Strength in Cerebral Palsy

April 25, 2018 updated by: Maastricht University Medical Center

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
370

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
t1 (base-line) and t1 (2-3 weeks later)
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.
t1 (base-line) and t1 (2-3 weeks later)
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.
t1 (base-line) and t1 (2-3 weeks later)
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.
t1 (base-line) and t1 (2-3 weeks later)
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.
t1 (base-line) and t1 (2-3 weeks later)
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.
t1 (base-line) and t1 (2-3 weeks later)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Maastricht University Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Maastricht University
VieCuri Medical Centre
Adelante, Centre of Expertise in Rehabilitation and Audiology
Revant
Tolbrug
Libra Zorggroep

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yvonne JM Janssen-Potten, PhD, Adelante, Centre of Expertise in Rehabilitation and Audiology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 19, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 19, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 21, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 23, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 26, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 26, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NL45430.068.13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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