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Completed

NCT Number: NCT03818152

Reliability and Validity of Strength Measurements of the Lower Limbs in Children With Bilateral Spastic Cerebral Palsy.

Specific musculo-tendinous adaptations in children with cerebral palsy (CP) have an influence on muscle strength and consequently on functional behavior and participation. Evidence of strength training programs has been shown on level of body function but transfer to levels of activity and participation is still limited. Lack of transfer is related to lack of specificity of the training and poor overall quality of the interventions (intensity, duration, frequency and/or type).

The use of functional strength exercises to assess and train strength of the lower limbs in children with CP is well implemented in the most functional children with CP (GMFCS-level I). To assess isometric strength the hand held dynamometer (HHD) can be used in clinical settings but reliability of this tool is questionable.

The aim of this study is to adapt existing functional strength tests for less functional children with CP (focussing on GMFCS level II and III) and to investigate the correlation with isometric strength measurements and other functional parameters.

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Key information

Conditions

Children Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Muscle Weakness Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ghent University

Ghent, 9000, Belgium

About this study

Specific musculo-tendinous adaptations in children with cerebral palsy (CP) have an influence on muscle strength and consequently on functional behavior and participation. Evidence of strength training programs has been shown on level of body function but transfer to levels of activity and participation is still limited. Lack of transfer is related to lack of specificity of the training and poor overall quality of the interventions (intensity, duration, frequency and/or type).

The use of functional strength exercises to assess and train strength of the lower limbs in children with CP is well implemented in the most functional children with CP (GMFCS-level I).

The aim of this study is to adapt existing functional strength tests for less functional children with CP (focussing on GMFCS-level II and III) and to investigate the correlation with isometric strength measurements and other functional parameters.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Bilateral spastic CP
  • GMFCS II-III
  • 6-18 Y
  • No botox until 4 months before testing
  • No orthopedic surgery until 1 Y before testing
  • Good cooperation

Treatment and study plan

Functional strength assessment

Other

Functional strength exercises to assess strength in lower limbs.

Primary outcomes

  1. Functional testing

    Time frame: 60 minutes

    30 seconds tests (nr/30 seconds): the children have to perform as much as trials as possible within 30 seconds; e.g. stand up and sit

Secondary outcomes

  1. Isometric strength test

    Time frame: 60 minutes

    Strength of the lower limbs (Nm) by means of a fixed hand held dynamometer

  2. Core stability test

    Time frame: 30 minutes

    30 seconds tests (nr/3 30 seconds test (nr/30 seconds)

  3. Gait capacity

    Time frame: 1 minute

    1 Minute Walking Test (m/1 minute)

  4. Gait capacity

    Time frame: 5 minutes

    Timed up and go (seconds)

Sponsors and collaborators

Lead sponsor

University Ghent

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 28, 2019
Registry last updated
Dec 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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