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Trial record 90 of 163 for:    Recruiting, Not yet recruiting, Available Studies | "Cerebral Palsy"

Walking Inclined Plane

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ClinicalTrials.gov Identifier: NCT02988557
Recruitment Status : Recruiting
First Posted : December 9, 2016
Last Update Posted : November 20, 2018
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Brief Summary:
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)

Condition or disease Intervention/treatment Phase
Cerebral Palsy Spastic Diplegia Procedure: walking on a treadmill with a sloped surface Device: treadmill Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Effect of an Inclined Plane on the Walking of Children With Cerebral Palsy: What Are the Paths for Rehabilitation?
Actual Study Start Date : February 21, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. minimal knee extension in stance (kinematics) [ Time Frame: 1 day (single evaluation) ]
    quantitative value of the extension (degree(s))



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Ages Eligible for Study:   6 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02988557


Contacts

Locations
France
CHU de Nantes Recruiting
Nantes, France, 44000
Contact: gross       raphael.gross@chu-nantes.fr   
Sponsors and Collaborators
Nantes University Hospital

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT02988557     History of Changes
Other Study ID Numbers: RC16_0089
First Posted: December 9, 2016    Key Record Dates
Last Update Posted: November 20, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nantes University Hospital:
cerebral palsy
gait
slope
electromyography

Additional relevant MeSH terms:
Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases