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

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ClinicalTrials.gov Identifier: NCT03818152
Recruitment Status : Completed
First Posted : January 28, 2019
Last Update Posted : October 22, 2019
Sponsor:
Information provided by (Responsible Party):
University Ghent

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Children Cerebral Palsy Muscle Weakness Other: Functional strength assessment Not Applicable

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Reliability and Validity of Strength Measurements of the Lower Limbs in Children With Bilateral Spastic Cerebral Palsy.
Actual Study Start Date : November 30, 2018
Actual Primary Completion Date : February 15, 2019
Actual Study Completion Date : February 15, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
study group
Reliability study isokinetic strength assessment of the lower limbs.
 Other: Functional strength assessment
Functional strength exercises to assess strength in lower limbs.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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)


Eligibility Criteria
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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03818152


Locations
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Belgium
Ghent University
Gent, Belgium, 9000
Sponsors and Collaborators
University Ghent
More Information
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Responsible Party: University Ghent
ClinicalTrials.gov Identifier: NCT03818152    
Other Study ID Numbers: B670201834766/Amendement
First Posted: January 28, 2019    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Ghent:
Cerebral palsy
Children
Functional strength measurement
Lower limbs
Reproducability
Additional relevant MeSH terms:
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Muscle Weakness
Paralysis
Cerebral Palsy
Neurologic Manifestations
Nervous System Diseases
Brain Damage, Chronic
 Brain Diseases
Central Nervous System Diseases
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Pathologic Processes