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

Centre Hospitalier Universitaire de Saint Etienne

Status: Withdrawn

Conditions: Cerebral Palsy

Treatments: Procedure: Wearing of night splint ankle foot orthoses (phase A); Procedure: No wearing of night splint ankle foot orthoses (phase B)

Study type: Interventional

Funder types: Other

Identifiers

NCT03686644

2018-A01082-53 (Other Identifier)

18CH070

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 8 to 16 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Children with Cerebral Palsy

Experimental group

Description:

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.

Treatment:

Procedure: Wearing of night splint ankle foot orthoses (phase A)

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