NCT02988557

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 7, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 9, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

February 21, 2017

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 11, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 11, 2020

Completed
Last Updated

August 6, 2020

Status Verified

July 1, 2020

Enrollment Period

3.1 years

First QC Date

December 7, 2016

Last Update Submit

August 5, 2020

Conditions

Cerebral PalsySpastic Diplegia

Keywords

cerebral palsygaitslopeelectromyography

Outcome Measures

Primary Outcomes (1)

  • minimal knee extension in stance (kinematics)

    quantitative value of the extension (degree(s))

    1 day (single evaluation)

Study Arms (1)

Treadmill

EXPERIMENTAL
Procedure: walking on a treadmill with a sloped surfaceDevice: treadmill

Interventions

walking on a treadmill with a sloped surfacePROCEDURE

walking on a treadmill with a sloped surface

Treadmill
treadmillDEVICE

walking on a treadmill with a sloped surface

Treadmill

Eligibility Criteria

Age6 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • botulinum toxin injection or lower limb surgery within the last year.
  • Uncontrolled seizures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nantes

Nantes, 44000, France

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometryInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2016

First Posted

December 9, 2016

Study Start

February 21, 2017

Primary Completion

March 11, 2020

Study Completion

March 11, 2020

Last Updated

August 6, 2020

Record last verified: 2020-07

Locations

FR(1)