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Walking Inclined Plane

Primary Purpose

Cerebral Palsy, Spastic Diplegia

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

walking on a treadmill with a sloped surface

treadmill

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring cerebral palsy, gait, slope, electromyography

Eligibility Criteria

6 Years - 14 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

CHU de Nantes

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treadmill

Arm Description

Outcomes

Primary Outcome Measures

minimal knee extension in stance (kinematics)

quantitative value of the extension (degree(s))

Secondary Outcome Measures

Full Information

NCT ID

NCT02988557

First Posted

December 7, 2016

Last Updated

August 5, 2020

Sponsor

Nantes University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02988557

Brief Title

Walking Inclined Plane

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Completed

Study Start Date

February 21, 2017 (Actual)

Primary Completion Date

March 11, 2020 (Actual)

Study Completion Date

March 11, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Nantes University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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)

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cerebral Palsy, Spastic Diplegia

Keywords

cerebral palsy, gait, slope, electromyography

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

29 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treadmill

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

walking on a treadmill with a sloped surface

Intervention Description

walking on a treadmill with a sloped surface

Intervention Type

Device

Intervention Name(s)

treadmill

Intervention Description

walking on a treadmill with a sloped surface

Primary Outcome Measure Information:

Title

minimal knee extension in stance (kinematics)

Description

quantitative value of the extension (degree(s))

Time Frame

1 day (single evaluation)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

14 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

CHU de Nantes

City

Nantes

ZIP/Postal Code

44000

Country

France

12. IPD Sharing Statement

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Walking Inclined Plane

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