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

Not Applicable

Withdrawn

• Conditions: Cerebral Palsy
• Interventions: Procedure: Wearing of night splint ankle foot orthoses (phase A); Procedure: No wearing of night splint ankle foot orthoses (phase B)

• Registration Number: NCT03686644
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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.

Study Timeline

• Study First Submitted: 2018-09-24
• Study First Submitted QC: 2018-09-26
• Study First Posted: 2018-09-27
• Study Start: 2018-10-16
• Primary Completion: 2018-10-16
• Study Completion: 2018-10-16
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-19
• Last Update Posted: 2022-07-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Children with Cerebral Palsy	Wearing of night splint ankle foot orthoses (phase A)	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 with Cerebral Palsy	No wearing of night splint ankle foot orthoses (phase B)	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.

Primary Outcome Measures

Name	Time	Method
change from baseline elasticity modulus of the leg muscles at 4 weeks	Weeks 0, 1, 2, 3 and 4	measured by ultrasounds

Secondary Outcome Measures

Name	Time	Method
Maximal dorsiflexion angle	Weeks 0, 1, 2, 3 and 4	Measured by isokinetic dynamometer.
Maximum angle of tense knee dorsiflexion	Weeks 0, 1, 2, 3 and 4	Measured by isokinetic dynamometer.
Torque of force maximal tolerated in maximum angle of tense knee dorsiflexion	Weeks 0, 1, 2, 3 and 4	Measured by isokinetic dynamometer.
Visual Analog Scale of sleeping	Weeks 0, 1, 2, 3 and 4	Measured the quality of night sleeping between 0 (bad sleeping) and 10 (good sleeping).