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CompletedNCT02988557Updated Aug 6, 2020

Walking Inclined Plane

An interventional study of walking on a treadmill with a sloped surface and treadmill in Cerebral Palsy and Spastic Diplegia, sponsored by Nantes University Hospital. Completed at 1 site in France. Open to participants aged 6 Years to 14 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-08-06.

Sponsored by Nantes University Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
29
Allocation
Not applicable
Ages
6 Years to 14 Years
Sex
All
01

Study 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)

Read the 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.

02

Conditions studied

  • Cerebral Palsy
  • Spastic Diplegia

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Keywords

  • cerebral palsy
  • gait
  • slope
  • electromyography
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In context

Cerebral Palsy

1,853 studies on the registry are indexed under Cerebral Palsy; 435 are open to participants now.

This study's enrollment of 29 is below the median of 33 across 1,368 interventional studies indexed under Cerebral Palsy.

Browse Cerebral Palsy studies →

Lead sponsor

Nantes University Hospital is the lead sponsor of 825 studies on the registry; 195 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 14 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
29 participants (actual)

Study arms

  • Experimental
    Treadmill

    Procedure: walking on a treadmill with a sloped surface · Device: treadmill

Interventions

  • Procedurewalking on a treadmill with a sloped surface

    walking on a treadmill with a sloped surface

  • Devicetreadmill

    walking on a treadmill with a sloped surface

06

What researchers measure

Primary outcomes

  1. minimal knee extension in stance (kinematics)

    quantitative value of the extension (degree(s))

    Time frame: 1 day (single evaluation)

07

Study locations

1 site
  • CHU de Nantes
    Nantes, 44000, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 6, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02988557
Lead sponsor
Nantes University Hospital
Responsible party
Sponsor
First posted
Dec 9, 2016
Start date
Feb 21, 2017
Primary completion
Mar 11, 2020
Completion
Mar 11, 2020
Last update
Aug 6, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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