Independent Walking Onset of Children With Cerebral Palsy

Cerebral Palsy Clinical Trial

— BB-AQM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03902886
• Other study ID #: BB-AQM ( 29BRC18.071)
• Status: Completed
• Start date: September 5, 2018
• Est. completion date: October 23, 2018

Study information

• Verified date: October 2018
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: October 23, 2018
• Est. primary completion date: October 23, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 36 Months

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Diagnostic Test:
• gait analysis
gait analysis using an optoelectronic system and a surface EMG

Locations

Country	Name	City	State
France	CHRU de Brest	Brest
Romania	Centrul National Clinic Recuperare Copii "Dr. N. Robanescu"	Bucharest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Countries where clinical trial is conducted

France,  Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.