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

NCT03686644 | Withdrawn

• 2 other identifiers: 18CH0702018-A01082-53
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cerebral Palsy

Keywords

night splinting; stiffness; ankle foot orthoses; teenager

Outcome Measures

Primary Outcomes (1)

• change from baseline elasticity modulus of the leg muscles at 4 weeks

  measured by ultrasounds

  Weeks 0, 1, 2, 3 and 4

Secondary Outcomes (4)

• 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

Study Arms (1)

Children with Cerebral Palsy

EXPERIMENTAL

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.

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

Interventions

Wearing of night splint ankle foot orthoses (phase A) PROCEDURE

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 with Cerebral Palsy

No wearing of night splint ankle foot orthoses (phase B) PROCEDURE

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.

Children with Cerebral Palsy

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Vincent GAUTHERON, MD PhD

  CHU de Saint Etienne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2018
• First Posted: September 27, 2018
• Study Start: October 16, 2018
• Primary Completion: October 16, 2018
• Study Completion: October 16, 2018
• Last Updated: July 22, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share