Ankle-foot Orthoses for Night Splinting in Children With CP: Impact on Passive Stiffness in Plantarflexors Muscles (NIGHTSTRETCH)
Effects of Wearing Orthoses on Nightly Postures on Passive Stiffness in Plantar Flexors Muscles in Children With Cerebral Palsy
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: 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.
|
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. 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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
change from baseline elasticity modulus of the leg muscles at 4 weeks
Time Frame: Weeks 0, 1, 2, 3 and 4
|
measured by ultrasounds
|
Weeks 0, 1, 2, 3 and 4
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maximal dorsiflexion angle
Time Frame: Weeks 0, 1, 2, 3 and 4
|
Measured by isokinetic dynamometer.
|
Weeks 0, 1, 2, 3 and 4
|
|
Maximum angle of tense knee dorsiflexion
Time Frame: Weeks 0, 1, 2, 3 and 4
|
Measured by isokinetic dynamometer.
|
Weeks 0, 1, 2, 3 and 4
|
|
Torque of force maximal tolerated in maximum angle of tense knee dorsiflexion
Time Frame: Weeks 0, 1, 2, 3 and 4
|
Measured by isokinetic dynamometer.
|
Weeks 0, 1, 2, 3 and 4
|
|
Visual Analog Scale of sleeping
Time Frame: Weeks 0, 1, 2, 3 and 4
|
Measured the quality of night sleeping between 0 (bad sleeping) and 10 (good sleeping).
|
Weeks 0, 1, 2, 3 and 4
|
Collaborators and Investigators
Investigators
- Principal Investigator: Vincent GAUTHERON, MD PhD, CHU de Saint Etienne
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18CH070
- 2018-A01082-53 (OTHER: ANSM)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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