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

  • France
      • 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
Procedure: walking on a treadmill with a sloped surface
walking on a treadmill with a sloped surface
Device: treadmill
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

Nantes University Hospital

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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