Clinical trial NCT04559776: Reliability of Newly-acquired Gait in Toddlers With a Typical Development and a Unilateral Cerebral Palsy
Official title: Reliability and Sources of Variability of 3D Kinematics and Muscle Activation Analysis of Newly-acquired Gait in Toddlers With a Typical Development and a Unilateral Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gait, Spastic
Reliability
Keywords: toddlers
3D motion analysis
EMG
reliability
Lead sponsor: National Clinical Center for Neuropsychomotor Recovery for Children Dr. Nicolae Robanescu
Sponsor class: OTHER
Collaborators: name: University Hospital, Brest
First posted: 2020-09-23
Enrollment: 41
Sex: ALL
Minimum age (years): 10
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: cross-sectional study with 2 groups of toddlers (with typical developing and with unilateral cerebral palsy) recorded twice in gait analysis within 30 days interval
Primary purpose: BASIC_SCIENCE

Brief summary: gait reliability study of toddlers with typically developing and with unilateral cerebral palsy during the first 6 months of independent walking

Detailed description: This study aim to assess lower limb kinematics and muscle EMG reliability during gait in typically developing toddlers and in toddlers with unilateral cerebral palsy with less than 6 months of independent walking experience and secondary to determine three sources of variability (between subjects, between sessions and between trials) using an optoelectronic system and a surface EMG system. The third aim was to identify the most reliable gait parameters.

This was a cross-sectional study conducted between January 2016 and May 2018 in the Motion Analysis Laboratory of the National Rehabilitation Center for Children (NRCC) "Dr. N. Robanescu", Bucharest (Romania). The toddlers with UCP were recruited among the inpatients and outpatients of the Pediatric Rehabilitation department. TD toddlers were recruited among the siblings of the toddlers with UCP and the children of people known to the investigators. Given the exploratory nature of this study, the target size of each group was set to a minimum of 10 participants per group.Toddlers from both groups were younger than 3 years old and independent walking experience of maximum 6 months. Every child was proposed to be evaluated in two gait analysis sessions within a period of 30 days. The second gait analysis session was planned approximately at 14 days from the first one. The two sessions were performed by the same experienced assessor.

The toddlers walked barefoot at self-selected pace. Each toddler was equipped with 19 reflective markers and 8 surface EMG electrodes. Data was collected with a BTS motion capture system equipped with 8 infrared cameras and 8 channels EMG system. The biomechanical model used was "Helen Hayes with medial markers".The EMG electrodes were positioned according to the SENIAM recommendations over the rectus femoris, the medial hamstrings, the tibialis anterior and the triceps surae.Visual 3D software (C-motion, Rockville, MD, USA) was used to build the kinematic model and identify gait cycles. A qualitative analysis was conducted for each gait cycle and each child in order to exclude the cycles during running or non-straight walking. Data was filtered and normalized. Three sources of variability (between subjects, between sessions and between trials) for kinematics and EMG data were quantified by calculating the standard deviations for each source.Standard Error of Measurement (SEM) for intertrials and intersessions were also calculated. For TD toddlers, a single value was reported as the quadratic mean for the right and left sides.

Eligibility criteria: Inclusion Criteria:

Toddlers from both groups were included in this study if they met the following inclusion criteria:

* up to 3 years of age,
* maximum independent walking experience of 6 months, and
* able to walk 5 metres without falling and with no technical assistance. Regarding the UCP group, one additional inclusion criterion was added: right or left hemiparesis with a typical history of CP (prematurity, before birth stroke, acute foetal distress/ birth hypoxia, brain malformations...).

Regarding the TD group, two additional inclusion criteria were: typical development and independent gait acquired before the age of 18 months.

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Exclusion Criteria:

Toddlers from both groups were excluded in case of

* trauma to the lower limbs in the last 6 months,
* a known skin allergy to any adhesive product, and
* any lower limb surgery. Toddlers in the UCP group were also excluded if they had botulinum toxin injections in the lower limb muscles in the previous 3 months.

Toddlers in the TD group were also excluded in the presence of a known neurological and/ or orthopaedic disorder.

Primary outcomes:
measure: intertrials and intersessions kinematic reliability
timeFrame: 3 years
measure: intertrials and intersessions EMG reliability
timeFrame: 3 years
Secondary outcomes:
measure: sources of variability for kinematics
timeFrame: 3 years
measure: sources of variability for EMG
timeFrame: 3 years
Other outcomes:
measure: identify the most reliable kinematic parameters
timeFrame: 3 years
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Study officials:
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