Independent Walking Onset of Children With Cerebral Palsy | NCT03902886

Studies
Independent Walking Onset of Children With Cerebral Palsy

NCT03902886

Sponsor

University Hospital, Brest

Status

Completed

Last Update Posted

Apr 4, 2019Actual

Enrollment

27Actual

Phase

Not provided

Conditions

Cerebral Palsy

Interventions

gait analysis

Countries

France
Romania

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 5, 2018Actual

Primary Completion Date

Oct 23, 2018Actual

Completion Date

Oct 23, 2018Actual

First Submitted Date

Oct 22, 2018

First Submission Date that Met QC Criteria

Apr 2, 2019

First Posted Date

Apr 4, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 2, 2019

Last Update Posted Date

Apr 4, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

27Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
cerebral palsy infants		gait analysis	Diagnostic Test: gait analysis
typically developed infants		gait analysis	Diagnostic Test: gait analysis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
gait analysis	Diagnostic Test	gait analysis using an optoelectronic system and a surface EMG	cerebral palsy infants typically developed infants

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The lower limbs Global Profile Score during gait	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.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

36 Months

Standard Ages

Child

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHRU de Brest		Brest		29609	France
Centrul National Clinic Recuperare Copii "Dr. N. Robanescu"

Condition Browse Module

MeSH Terms

ID	Term
D002547	Cerebral Palsy

Ancestor Terms

ID	Term
D001925	Brain Damage, Chronic
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077107	Gait Analysis

Ancestor Terms

ID	Term
D005684	Gait
D010808	Physical Examination
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided