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

Primary Purpose

Children, Cerebral Palsy, Muscle Weakness

Status

Completed

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

Functional strength assessment

About this trial

This is an interventional treatment trial for Children focused on measuring Cerebral palsy, Children, Functional strength measurement, Lower limbs, Reproducability

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Ghent University

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

study group

Arm Description

Reliability study isokinetic strength assessment of the lower limbs.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Isometric strength test

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

Core stability test

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

Gait capacity

1 Minute Walking Test (m/1 minute)

Gait capacity

Timed up and go (seconds)

Full Information

NCT ID

NCT03818152

First Posted

January 25, 2019

Last Updated

October 18, 2019

Sponsor

University Ghent

1. Study Identification

Unique Protocol Identification Number

NCT03818152

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2019

Overall Recruitment Status

Completed

Study Start Date

November 30, 2018 (Actual)

Primary Completion Date

February 15, 2019 (Actual)

Study Completion Date

February 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Ghent

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Children, Cerebral Palsy, Muscle Weakness

Keywords

Cerebral palsy, Children, Functional strength measurement, Lower limbs, Reproducability

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

study group

Arm Type

Other

Arm Description

Reliability study isokinetic strength assessment of the lower limbs.

Intervention Type

Other

Intervention Name(s)

Functional strength assessment

Intervention Description

Functional strength exercises to assess strength in lower limbs.

Primary Outcome Measure Information:

Title

Functional testing

Description

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

Time Frame

60 minutes

Secondary Outcome Measure Information:

Title

Isometric strength test

Description

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

Time Frame

60 minutes

Title

Core stability test

Description

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

Time Frame

30 minutes

Title

Gait capacity

Description

1 Minute Walking Test (m/1 minute)

Time Frame

1 minute

Title

Gait capacity

Description

Timed up and go (seconds)

Time Frame

5 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

Ghent University

City

Gent

ZIP/Postal Code

9000

Country

Belgium

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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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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