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

NCT ID: NCT03686644

Last Updated: 2022-07-22

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-16
• Study Completion Date: 2018-10-16

Brief 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

Cerebral Palsy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Children with Cerebral Palsy

Children with Cerebral Palsy (CP) will be included. They will have to wearing of night splint ankle foot orthoses (phase A) and then no wearing of night splint ankle foot orthoses (phase B). The phases A and B will be repeated twice. In more, they will have an ultrasound, isokinetic dynamometer and measure of quality of night sleeping.

Group Type: EXPERIMENTAL

Wearing of night splint ankle foot orthoses (phase A)

Intervention Type: PROCEDURE

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.

No wearing of night splint ankle foot orthoses (phase B)

Intervention Type: PROCEDURE

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.

Interventions

Wearing 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.

Intervention Type: PROCEDURE

No 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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Children diagnosed spastic cerebral palsy
• Children wearing night splint ankle foot orthoses all night long during 1 week minimum
• Children with a level of spasticity in the gastrocnemius muscle greater than or equal to X1, VII, on the Tardieu scale and 2 on the Ashworth scale.
• Children able to understand and respect the simple instructions of the study
• Children and parents who received informed information about the study and who co-signed, with the investigator, a consent to participate in the study.

Exclusion Criteria

• Children who do not tolerate ankle foot orthoses all night long.
• Children who had botulinum injection in gastrocnemius or soleus muscles during last three months.
• Children benefiting from an injection of botulinum toxin or the setting up of new equipment during the protocol.
• Children who do not tolerate ankle foot orthoses all night long.
• Children having benefited from plaster lengthening for less than three months.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vincent GAUTHERON, MD PhD

Role: PRINCIPAL_INVESTIGATOR

CHU de Saint Etienne

Other Identifiers

2018-A01082-53

Identifier Type: OTHER

Identifier Source: secondary_id

18CH070

Identifier Type: -

Identifier Source: org_study_id