Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT03686644

Ankle-foot Orthoses for Night Splinting in Children With CP: Impact on Passive Stiffness in Plantarflexors Muscles

Effects of Wearing Orthoses on Nightly Postures on Passive Stiffness in Plantar Flexors Muscles in Children With Cerebral Palsy

Status
Withdrawn
Phase
N/A
Study type
Interventional
Enrollment
0 (actual)
Sponsor
Centre Hospitalier Universitaire de Saint Etienne · Academic / Other
Sex
All
Age
8 Years – 16 Years
Healthy volunteers
Not accepted

Summary

Children with cerebral palsy present early in the childhood altered muscular properties, characterized by short muscle belly length and increased stiffness which contribute to contracture and limiting joint range of motion. In order to prevent equinus deformity, ankle foot orthoses for night splinting are usually used in children with spastic Cerebral Palsy (CP). However, there's a lack of proof about efficacy by using this modality of treatment. Moreover, impact on quality of life for children and families, cost for society were high. Principal purpose of this study was to assess impact of night splint ankle foot orthoses on passive stiffness in plantarflexors muscles in children with CP.

Detailed description

Children with cerebral palsy present early in the childhood altered muscular properties, characterized by short muscle belly length and increased stiffness which contribute to contracture and limiting joint range of motion. In order to prevent equinus deformity, ankle foot orthoses for night splinting are usually used in children with spastic CP. However, there's a lack of proof about efficacy by using this modality of treatment. Moreover, impact on quality of life for children and families, cost for society were high.

Conditions

Interventions

TypeNameDescription
PROCEDUREWearing of night splint ankle foot orthoses (phase A)Children wearing of night splint ankle foot orthoses during 6, 7 or 8 days according to the position of inclusion. An ultrasound of the leg muscles will be realized every morning after removing night splint. An isokinetic dynamometer will be realize at the beginning of the study and at the end of each phase. measure of quality of night sleeping will be measured by Visual Analog Scale (VAS) results.
PROCEDURENo wearing of night splint ankle foot orthoses (phase B)Children no wearing of night splint ankle foot orthoses during 6, 7 or 8 days according to the position of inclusion. An ultrasound of the leg muscles will be realized every morning after removing night splint. An isokinetic dynamometer will be realize at the beginning of the study and at the end of each phase. measure of quality of night sleeping will be measured by Visual Analog Scale (VAS) results.

Timeline

Start date
2018-10-16
Primary completion
2018-10-16
Completion
2018-10-16
First posted
2018-09-27
Last updated
2022-07-22

Source: ClinicalTrials.gov record NCT03686644. Inclusion in this directory is not an endorsement.