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Reliability of Newly-acquired Gait in Toddlers With a Typical Development and a Unilateral Cerebral Palsy (ReliabBB-AQM)

Primary Purpose

Gait, Spastic, Reliability

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
gait analysis
Sponsored by
National Clinical Center for Neuropsychomotor Recovery for Children Dr. Nicolae Robanescu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Gait, Spastic focused on measuring toddlers, 3D motion analysis, EMG, reliability

Eligibility Criteria

10 Months - 36 Months (Child)All SexesAccepts Healthy Volunteers

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.

-

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    typically developing toddlers

    unilateral cerebral palsy toddlers

    Arm Description

    toddlers with a typical development and with less than 3 years old and less than 6 months of independent walking

    toddlers with a unilateral cerebral plasy and with less than 3 years old and less than 6 months of independent walking

    Outcomes

    Primary Outcome Measures

    intertrials and intersessions kinematic reliability
    Assess lower limb joint angles reliability during gait in TD toddlers and with toddlers with unilateral cerebral palsy (UCP) with less than 6 months of independent walking experience by calculating the Standard Error of Measurement (SEM) for each joint of the lower limb and each motion plane and in each group of toddlers (TD and UCP). For UCP toddlers, the SEM was calculated separately for the affected and the non-affected sides. SEM values for joint angles are expressed in degrees.
    intertrials and intersessions EMG reliability
    Assess lower limb reliability of the muscular EMG envelops during gait in TD toddlers and with toddlers with unilateral cerebral palsy (UCP) with less than 6 months of independent walking experience by calculating the Standard Error of Measurement (SEM) for of the four muscles studied (rectus femoris, medial hamstrings, tibialis anterior and triceps surae) and in each group of toddlers (TD and UCP). For UCP toddlers, the SEM was calculated separately for the affected and the non-affected sides. SEM values for EMG envelopes have no units of measure since the EMG envelope of a muscle is normalized by the maximum amplitude of the EMG signal of that muscle for all gait cycles for a subject.

    Secondary Outcome Measures

    sources of variability for kinematics
    Assess 3 sources of gait variability (intersubjects, intersessions, intertrials) during gait in TD toddlers and with toddlers with unilateral cerebral palsy (UCP) with less than 6 months of independent walking experience, by calculating the Standard Deviation (SD) for each joint and each motion plane of lower limb joint and in each group of toddlers (TD and UCP). For UCP toddlers, the SD was calculated separately for the affected and the non-affected sides. SD values for joint angles are expressed in degrees.
    sources of variability for EMG
    Assess 3 sources of gait variability (intersubjects, intersessions, intertrials) of the muscular EMG envelops during gait in TD toddlers and with toddlers with unilateral cerebral palsy (UCP) with less than 6 months of independent walking experience by calculating the Standard Deviation (SD) for of the four muscles studied (rectus femoris, medial hamstrings, tibialis anterior and triceps surae) and in each group of toddlers (TD and UCP). For UCP toddlers, the SD was calculated separately for the affected and the non-affected sides. SD values for EMG envelopes have no units of measure since the EMG envelope of a muscle is normalized by the maximum amplitude of the EMG signal of that muscle for all gait cycles for a subject.

    Full Information

    First Posted
    September 1, 2020
    Last Updated
    September 16, 2020
    Sponsor
    National Clinical Center for Neuropsychomotor Recovery for Children Dr. Nicolae Robanescu
    Collaborators
    University Hospital, Brest
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04559776
    Brief Title
    Reliability of Newly-acquired Gait in Toddlers With a Typical Development and a Unilateral Cerebral Palsy
    Acronym
    ReliabBB-AQM
    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

    2. Study Status

    Record Verification Date
    September 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    January 5, 2016 (Actual)
    Primary Completion Date
    May 31, 2018 (Actual)
    Study Completion Date
    December 31, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    National Clinical Center for Neuropsychomotor Recovery for Children Dr. Nicolae Robanescu
    Collaborators
    University Hospital, Brest

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gait, Spastic, Reliability
    Keywords
    toddlers, 3D motion analysis, EMG, reliability

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    41 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    typically developing toddlers
    Arm Type
    Experimental
    Arm Description
    toddlers with a typical development and with less than 3 years old and less than 6 months of independent walking
    Arm Title
    unilateral cerebral palsy toddlers
    Arm Type
    Experimental
    Arm Description
    toddlers with a unilateral cerebral plasy and with less than 3 years old and less than 6 months of independent walking
    Intervention Type
    Other
    Intervention Name(s)
    gait analysis
    Intervention Description
    gait analysis with 3D optoelectronic system and surface EMG
    Primary Outcome Measure Information:
    Title
    intertrials and intersessions kinematic reliability
    Description
    Assess lower limb joint angles reliability during gait in TD toddlers and with toddlers with unilateral cerebral palsy (UCP) with less than 6 months of independent walking experience by calculating the Standard Error of Measurement (SEM) for each joint of the lower limb and each motion plane and in each group of toddlers (TD and UCP). For UCP toddlers, the SEM was calculated separately for the affected and the non-affected sides. SEM values for joint angles are expressed in degrees.
    Time Frame
    3 years
    Title
    intertrials and intersessions EMG reliability
    Description
    Assess lower limb reliability of the muscular EMG envelops during gait in TD toddlers and with toddlers with unilateral cerebral palsy (UCP) with less than 6 months of independent walking experience by calculating the Standard Error of Measurement (SEM) for of the four muscles studied (rectus femoris, medial hamstrings, tibialis anterior and triceps surae) and in each group of toddlers (TD and UCP). For UCP toddlers, the SEM was calculated separately for the affected and the non-affected sides. SEM values for EMG envelopes have no units of measure since the EMG envelope of a muscle is normalized by the maximum amplitude of the EMG signal of that muscle for all gait cycles for a subject.
    Time Frame
    3 years
    Secondary Outcome Measure Information:
    Title
    sources of variability for kinematics
    Description
    Assess 3 sources of gait variability (intersubjects, intersessions, intertrials) during gait in TD toddlers and with toddlers with unilateral cerebral palsy (UCP) with less than 6 months of independent walking experience, by calculating the Standard Deviation (SD) for each joint and each motion plane of lower limb joint and in each group of toddlers (TD and UCP). For UCP toddlers, the SD was calculated separately for the affected and the non-affected sides. SD values for joint angles are expressed in degrees.
    Time Frame
    3 years
    Title
    sources of variability for EMG
    Description
    Assess 3 sources of gait variability (intersubjects, intersessions, intertrials) of the muscular EMG envelops during gait in TD toddlers and with toddlers with unilateral cerebral palsy (UCP) with less than 6 months of independent walking experience by calculating the Standard Deviation (SD) for of the four muscles studied (rectus femoris, medial hamstrings, tibialis anterior and triceps surae) and in each group of toddlers (TD and UCP). For UCP toddlers, the SD was calculated separately for the affected and the non-affected sides. SD values for EMG envelopes have no units of measure since the EMG envelope of a muscle is normalized by the maximum amplitude of the EMG signal of that muscle for all gait cycles for a subject.
    Time Frame
    3 years
    Other Pre-specified Outcome Measures:
    Title
    identify the most reliable kinematic parameters
    Description
    identify those joints and planes where the Standard Error of Measurement (SEM) calculated for primary outcome have values below 5 degrees.
    Time Frame
    3 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    10 Months
    Maximum Age & Unit of Time
    36 Months
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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. - 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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Reliability of Newly-acquired Gait in Toddlers With a Typical Development and a Unilateral Cerebral Palsy

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