Independent Walking Onset of Children With Cerebral Palsy (BB-AQM)

April 2, 2019 updated by: University Hospital, Brest

Biomechanics and Motor Control of the First 6 Months of Independent Walking for Children With Unilateral Cerebral Palsy

This study will focus the gait analysis, using an optoelectronic system, of children with unilateral cerebral palsy compared to typically developed children in the first 6 months of independent walking.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

27

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Brest, France, 29609
        • CHRU de Brest
  • Romania
      • Bucharest, Romania, 041408
        • Centrul National Clinic Recuperare Copii "Dr. N. Robanescu"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 3 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

10 toddlers with unilateral CP will be compared to 10 toddlers typically developed. The populations will have maximum 6 months of walking experience.

Description

Inclusion Criteria:

  • Maximum age of 3 years old
  • Independent walking experience of maximum 6 months
  • Ability to walk 5 m without falling or needing a technical assistance
  • A right or left hemiplegia in a predictive clinical context of a CP at the age of 2 years

Exclusion Criteria:

  • History of lower limb musculoskeletal trauma in the last 6 months
  • A known skin allergy to any adhesive product
  • History of lower limb musculoskeletal surgery
  • History of BTX injections into the lower limbs muscles in the last 3 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
cerebral palsy infants
gait analysis
Diagnostic test: gait analysis
gait analysis using an optoelectronic system and a surface EMG
typically developed infants
gait analysis
Diagnostic test: gait analysis
gait analysis using an optoelectronic system and a surface EMG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The lower limbs Global Profile Score during gait
Time Frame: All the data collection and analysis wil be done within 2 months from the start point of the study.
Data will be collected from gait analysis of unilateral CP children and the Global Profile Score, characterizing the overall kinematics of the pelvis and lower limbs, during gait, will be compared those of a typical developed children group matched in walking experience. Mann Whitney U test will be used for this comparison.
All the data collection and analysis wil be done within 2 months from the start point of the study.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Brest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 5, 2018

Primary Completion (Actual)

October 23, 2018

Study Completion (Actual)

October 23, 2018

Study Registration Dates

First Submitted

October 22, 2018

First Submitted That Met QC Criteria

April 2, 2019

First Posted (Actual)

April 4, 2019

Study Record Updates

Last Update Posted (Actual)

April 4, 2019

Last Update Submitted That Met QC Criteria

April 2, 2019

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BB-AQM ( 29BRC18.071)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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