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

Cerebral Palsy Clinical Trial

— NIGHTSTRETCH  

Official title:

Effects of Wearing Orthoses on Nightly Postures on Passive Stiffness in Plantar Flexors Muscles in Children With Cerebral Palsy

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03686644
• Other study ID #: 18CH070
• Secondary ID: 2018-A01082-53
• Status: Withdrawn
• Phase: N/A
• Start date: October 16, 2018
• Est. completion date: October 16, 2018

Study information

• Verified date: July 2022
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 16, 2018
• Est. primary completion date: October 16, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change from baseline elasticity modulus of the leg muscles at 4 weeks	measured by ultrasounds	Weeks 0, 1, 2, 3 and 4
Secondary	Maximal dorsiflexion angle	Measured by isokinetic dynamometer.	Weeks 0, 1, 2, 3 and 4
Secondary	Maximum angle of tense knee dorsiflexion	Measured by isokinetic dynamometer.	Weeks 0, 1, 2, 3 and 4
Secondary	Torque of force maximal tolerated in maximum angle of tense knee dorsiflexion	Measured by isokinetic dynamometer.	Weeks 0, 1, 2, 3 and 4
Secondary	Visual Analog Scale of sleeping	Measured the quality of night sleeping between 0 (bad sleeping) and 10 (good sleeping).	Weeks 0, 1, 2, 3 and 4