Upper Extremity Strength in Cerebral Palsy

NCT02146989 | Completed

• 1 other identifier: NL45430.068.13
• Study Type: observational
• Target: 370
• Locations: 1 country
• Sites: 9

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.

Conditions

Cerebral Palsy

Keywords

Cerebral Palsy; child; upper extremity; strength, reproducibility

Outcome Measures

Primary Outcomes (6)

• 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)

Study Arms (2)

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

Healthy controls

Children and adolescents without Cerebral Palsy

Other: reproducibility of upper extremity strength measurements

Interventions

reproducibility of upper extremity strength measurements OTHER

inter-rater reliability and test-retest reliability

Also known as: Hand Held Dynamometry, E-link system, functional strength measurements

Cerebral Palsy; Healthy controls

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Spastic unilateral Cerebral Palsy and Healthy Controls

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (9)

Adelante

Hoensbroek, Limburg, 6432CC, Netherlands

Location

Tolbrug

's-Hertogenbosch, 5200 ME, Netherlands

Location

Klimmendaal

Arnhem, 6813 GC, Netherlands

Location

Revant

Breda, 4817 JW, Netherlands

Location

Libra Zorggroep

Eindhoven, 5602 BJ, Netherlands

Location

Rijnlands Revalidatie Centrum

Leiden, 2333 AL, Netherlands

Location

St. Maartenskliniek

Nijmegen, 6574 NA, Netherlands

Location

Sophie Revalidatie

The Hague, 2543 SW, Netherlands

Location

Viecuri Medical Centre

Venlo, 5912 BL, Netherlands

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Yvonne JM Janssen-Potten, PhD

  Adelante, Centre of Expertise in Rehabilitation and Audiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2014
• First Posted: May 26, 2014
• Study Start: June 1, 2014
• Primary Completion: March 19, 2018
• Study Completion: March 19, 2018
• Last Updated: April 26, 2018

Record last verified: 2018-04

Locations

NL (9)