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Completed

NCT Number: NCT02988557

Walking Inclined Plane

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)

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases Spastic Diplegia

Age range

6 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nantes

Nantes, 44000, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

walking on a treadmill with a sloped surface

Procedure

walking on a treadmill with a sloped surface

Treadmill

Device

walking on a treadmill with a sloped surface

Primary outcomes

  1. minimal knee extension in stance (kinematics)

    Time frame: 1 day (single evaluation)

    quantitative value of the extension (degree(s))

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

Evaluation of the Effect of an Inclined Plane on the Walking of Children With Cerebral Palsy: What Are the Paths for Rehabilitation?

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Dec 9, 2016
Registry last updated
Aug 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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