Reliability and Validity of Strength Measurements of the... | NCT03818152

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

NCT03818152

Sponsor

University Ghent

Status

Completed

Last Update Posted

Dec 13, 2023Actual

Enrollment

24Actual

Phase

Not Applicable

Conditions

Children
Cerebral Palsy
Muscle Weakness

Interventions

Functional strength assessment

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 30, 2018Actual

Primary Completion Date

Feb 15, 2019Actual

Completion Date

Feb 15, 2019Actual

First Submitted Date

Jan 25, 2019

First Submission Date that Met QC Criteria

Jan 25, 2019

First Posted Date

Jan 28, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 12, 2023

Last Update Posted Date

Dec 13, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
study group	Other	Reliability study isokinetic strength assessment of the lower limbs.	Other: Functional strength assessment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Functional strength assessment	Other	Functional strength exercises to assess strength in lower limbs.	study group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Isometric strength test	Strength of the lower limbs (Nm) by means of a fixed hand held dynamometer	60 minutes
Core stability test	30 seconds tests (nr/3 30 seconds test (nr/30 seconds)

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ghent University		Ghent		9000	Belgium

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002547	Cerebral Palsy
D018908	Muscle Weakness

Ancestor Terms

ID	Term
D001925	Brain Damage, Chronic
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

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Browse Branches

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