Walking Inclined Plane

NCT ID: NCT02988557

Last Updated: 2020-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-21

Study Completion Date

2020-03-11

Brief Summary

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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)

Detailed Description

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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.

Conditions

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Cerebral Palsy Spastic Diplegia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treadmill

Group Type EXPERIMENTAL

walking on a treadmill with a sloped surface

Intervention Type PROCEDURE

walking on a treadmill with a sloped surface

treadmill

Intervention Type DEVICE

walking on a treadmill with a sloped surface

Interventions

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walking on a treadmill with a sloped surface

walking on a treadmill with a sloped surface

Intervention Type PROCEDURE

treadmill

walking on a treadmill with a sloped surface

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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


* age = 6-14 years old

Exclusion Criteria

* botulinum toxin injection or lower limb surgery within the last year.
* Uncontrolled seizures
Minimum Eligible Age

6 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU de Nantes

Nantes, , France

Site Status

Countries

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France

Other Identifiers

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RC16_0089

Identifier Type: -

Identifier Source: org_study_id

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