- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02988557
Walking Inclined Plane
August 5, 2020 updated by: Nantes University Hospital
Evaluation of the Effect of an Inclined Plane on the Walking of Children With Cerebral Palsy: What Are the Paths for Rehabilitation?
The adaptations in kinematics and muscle activity, investigated by 3D gait analysis and dynamic electromyography recordings, will be studied in children with bilateral spastic cerebral palsy during level walking, and before and after a training on a treadmill with a sloped surface (7°).
Data will be compared with those obtained in a sample of typically developing (TD) children (controls)
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
15 CP children and 15 TD children aged 6 to 14 years will take part in this study.
Dynamic EMG recordings will be performed as well as kinematic data assessments through a gait analysis system.
Three different slopes will be assessed, using a treadmill.
The primary outcome measure will be the minimal knee extension value in the stance phase.
The changes in kinematics will be overall assessed through the Gait Profile Score (Baker et al.).
The details in changes will be assessed through statistical parametric mapping (SPM).
The changes in muscle activity induced by the slope will be investigated by statistical parametric mapping of the EMG or kinematic data.
Study Type
Interventional
Enrollment (Actual)
29
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Nantes, France, 44000
- CHU de Nantes
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 14 years (CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria for children with CP:
- age = 6-14 years old
- children with cerebral palsy: spastic type, bilateral involvement, forefoot initial contact and/or excessive knee flexion at mid-stance and/or decreased hip extension in late stance.
- GMFCS I or II,
- Score on Gillette scale between 8 and 10
- able to walk at least 10 min without help
Inclusion Criteria for TD children:
- age = 6-14 years old
Exclusion Criteria:
- botulinum toxin injection or lower limb surgery within the last year.
- Uncontrolled seizures
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Treadmill
|
walking on a treadmill with a sloped surface
walking on a treadmill with a sloped surface
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
minimal knee extension in stance (kinematics)
Time Frame: 1 day (single evaluation)
|
quantitative value of the extension (degree(s))
|
1 day (single evaluation)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
February 21, 2017
Primary Completion (ACTUAL)
March 11, 2020
Study Completion (ACTUAL)
March 11, 2020
Study Registration Dates
First Submitted
December 7, 2016
First Submitted That Met QC Criteria
December 8, 2016
First Posted (ESTIMATE)
December 9, 2016
Study Record Updates
Last Update Posted (ACTUAL)
August 6, 2020
Last Update Submitted That Met QC Criteria
August 5, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC16_0089
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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