Independent Walking Onset of Children With Cerebral Palsy
BB-AQM
Biomechanics and Motor Control of the First 6 Months of Independent Walking for Children With Unilateral Cerebral Palsy
1 other identifier
observational
27
2 countries
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Sep 2018
Shorter than P25 for all trials
2 active sites
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
Study Start
First participant enrolled
September 5, 2018
CompletedFirst Submitted
Initial submission to the registry
October 22, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 23, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 23, 2018
CompletedFirst Posted
Study publicly available on registry
April 4, 2019
CompletedApril 4, 2019
October 1, 2018
2 months
October 22, 2018
April 2, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Study Arms (2)
cerebral palsy infants
gait analysis
typically developed infants
gait analysis
Interventions
gait analysis using an optoelectronic system and a surface EMG
Eligibility Criteria
10 toddlers with unilateral CP will be compared to 10 toddlers typically developed. The populations will have maximum 6 months of walking experience.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
CHRU de Brest
Brest, 29609, France
Centrul National Clinic Recuperare Copii "Dr. N. Robanescu"
Bucharest, 041408, Romania
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 22, 2018
First Posted
April 4, 2019
Study Start
September 5, 2018
Primary Completion
October 23, 2018
Study Completion
October 23, 2018
Last Updated
April 4, 2019
Record last verified: 2018-10