Walking Inclined Plane

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02988557
• Other study ID #: RC16_0089
• Status: Completed
• Phase: N/A
• Start date: February 21, 2017
• Est. completion date: March 11, 2020

Study information

• Verified date: July 2020
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: March 11, 2020
• Est. primary completion date: March 11, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Spastic Diplegia

Intervention

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

Locations

Country	Name	City	State
France	CHU de Nantes	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	minimal knee extension in stance (kinematics)	quantitative value of the extension (degree(s))	1 day (single evaluation)