Effects of Wearing Orthoses on Nightly Postures on Passive Stiffness in Plantar Flexors Muscles in Children With Cerebral Palsy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cerebral Palsy
- Sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Primary Endpoint
- change from baseline elasticity modulus of the leg muscles at 4 weeks
- Status
- Withdrawn
- Last Updated
- 3 years ago
Overview
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.
Investigators
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.
Outcomes
Primary Outcomes
change from baseline elasticity modulus of the leg muscles at 4 weeks
Time Frame: Weeks 0, 1, 2, 3 and 4
measured by ultrasounds
Secondary Outcomes
- Maximal dorsiflexion angle(Weeks 0, 1, 2, 3 and 4)
- Maximum angle of tense knee dorsiflexion(Weeks 0, 1, 2, 3 and 4)
- Torque of force maximal tolerated in maximum angle of tense knee dorsiflexion(Weeks 0, 1, 2, 3 and 4)
- Visual Analog Scale of sleeping(Weeks 0, 1, 2, 3 and 4)