NCT03818152

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 30, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 28, 2019

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2019

Completed
Last Updated

December 13, 2023

Status Verified

December 1, 2023

Enrollment Period

3 months

First QC Date

January 25, 2019

Last Update Submit

December 12, 2023

Conditions

ChildrenCerebral PalsyMuscle Weakness

Keywords

Cerebral palsyChildrenFunctional strength measurementLower limbsReproducability

Outcome Measures

Primary Outcomes (1)

  • Functional testing

    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

    60 minutes

Secondary Outcomes (4)

  • Isometric strength test

    60 minutes

  • Core stability test

    30 minutes

  • Gait capacity

    1 minute

  • Gait capacity

    5 minutes

Study Arms (1)

study group

OTHER

Reliability study isokinetic strength assessment of the lower limbs.

Other: Functional strength assessment

Interventions

Functional strength assessmentOTHER

Functional strength exercises to assess strength in lower limbs.

study group

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghent University

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Cerebral PalsyMuscle Weakness

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMuscular DiseasesMusculoskeletal DiseasesNeuromuscular ManifestationsNeurologic ManifestationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2019

First Posted

January 28, 2019

Study Start

November 30, 2018

Primary Completion

February 15, 2019

Study Completion

February 15, 2019

Last Updated

December 13, 2023

Record last verified: 2023-12

Locations

BE(1)