Clinical trial NCT03686644: Ankle-foot Orthoses for Night Splinting in Children With CP: Impact on Passive Stiffness in Plantarflexors Muscles
Official title: Effects of Wearing Orthoses on Nightly Postures on Passive Stiffness in Plantar Flexors Muscles in Children With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cerebral Palsy
Keywords: night splinting
stiffness
ankle foot orthoses
teenager
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2018-09-27
Enrollment: 0
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: change from baseline elasticity modulus of the leg muscles at 4 weeks
timeFrame: Weeks 0, 1, 2, 3 and 4
Secondary outcomes:
measure: Maximal dorsiflexion angle
timeFrame: Weeks 0, 1, 2, 3 and 4
measure: Maximum angle of tense knee dorsiflexion
timeFrame: Weeks 0, 1, 2, 3 and 4
measure: Torque of force maximal tolerated in maximum angle of tense knee dorsiflexion
timeFrame: Weeks 0, 1, 2, 3 and 4
measure: Visual Analog Scale of sleeping
timeFrame: Weeks 0, 1, 2, 3 and 4
Other outcomes:
Locations:
Study officials:
affiliation: CHU de Saint Etienne
name: Vincent GAUTHERON, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: