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

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03818152
• Other study ID #: B670201834766/Amendement
• Status: Completed
• Phase: N/A
• Start date: November 30, 2018
• Est. completion date: February 15, 2019

Study information

• Verified date: December 2023
• Source: University Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: February 15, 2019
• Est. primary completion date: February 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Children
• Muscle Weakness
• Paralysis

Intervention

Other:
• Functional strength assessment
Functional strength exercises to assess strength in lower limbs.

Locations

Country	Name	City	State
Belgium	Ghent University	Gent

Sponsors (1)

Lead Sponsor	Collaborator
University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Isometric strength test	Strength of the lower limbs (Nm) by means of a fixed hand held dynamometer	60 minutes
Secondary	Core stability test	30 seconds tests (nr/3 30 seconds test (nr/30 seconds)	30 minutes
Secondary	Gait capacity	1 Minute Walking Test (m/1 minute)	1 minute
Secondary	Gait capacity	Timed up and go (seconds)	5 minutes