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

Primary Purpose

Cerebral Palsy

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Wearing of night splint ankle foot orthoses (phase A)
No wearing of night splint ankle foot orthoses (phase B)
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cerebral Palsy focused on measuring night splinting, stiffness, ankle foot orthoses, teenager

Eligibility Criteria

8 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Children with Cerebral Palsy

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    change from baseline elasticity modulus of the leg muscles at 4 weeks
    measured by ultrasounds

    Secondary Outcome Measures

    Maximal dorsiflexion angle
    Measured by isokinetic dynamometer.
    Maximum angle of tense knee dorsiflexion
    Measured by isokinetic dynamometer.
    Torque of force maximal tolerated in maximum angle of tense knee dorsiflexion
    Measured by isokinetic dynamometer.
    Visual Analog Scale of sleeping
    Measured the quality of night sleeping between 0 (bad sleeping) and 10 (good sleeping).

    Full Information

    First Posted
    September 24, 2018
    Last Updated
    July 19, 2022
    Sponsor
    Centre Hospitalier Universitaire de Saint Etienne
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03686644
    Brief Title
    Ankle-foot Orthoses for Night Splinting in Children With CP: Impact on Passive Stiffness in Plantarflexors Muscles
    Acronym
    NIGHTSTRETCH
    Official Title
    Effects of Wearing Orthoses on Nightly Postures on Passive Stiffness in Plantar Flexors Muscles in Children With Cerebral Palsy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2022
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    never started
    Study Start Date
    October 16, 2018 (Actual)
    Primary Completion Date
    October 16, 2018 (Actual)
    Study Completion Date
    October 16, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Centre Hospitalier Universitaire de Saint Etienne

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cerebral Palsy
    Keywords
    night splinting, stiffness, ankle foot orthoses, teenager

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Children with Cerebral Palsy
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Wearing of night splint ankle foot orthoses (phase A)
    Intervention Description
    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.
    Intervention Type
    Procedure
    Intervention Name(s)
    No wearing of night splint ankle foot orthoses (phase B)
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    change from baseline elasticity modulus of the leg muscles at 4 weeks
    Description
    measured by ultrasounds
    Time Frame
    Weeks 0, 1, 2, 3 and 4
    Secondary Outcome Measure Information:
    Title
    Maximal dorsiflexion angle
    Description
    Measured by isokinetic dynamometer.
    Time Frame
    Weeks 0, 1, 2, 3 and 4
    Title
    Maximum angle of tense knee dorsiflexion
    Description
    Measured by isokinetic dynamometer.
    Time Frame
    Weeks 0, 1, 2, 3 and 4
    Title
    Torque of force maximal tolerated in maximum angle of tense knee dorsiflexion
    Description
    Measured by isokinetic dynamometer.
    Time Frame
    Weeks 0, 1, 2, 3 and 4
    Title
    Visual Analog Scale of sleeping
    Description
    Measured the quality of night sleeping between 0 (bad sleeping) and 10 (good sleeping).
    Time Frame
    Weeks 0, 1, 2, 3 and 4

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    8 Years
    Maximum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Vincent GAUTHERON, MD PhD
    Organizational Affiliation
    CHU de Saint Etienne
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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