Reliability Clinical Trial
— ReliabBB-AQMOfficial 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
gait reliability study of toddlers with typically developing and with unilateral cerebral palsy during the first 6 months of independent walking
Status | Completed |
Enrollment | 41 |
Est. completion date | December 31, 2018 |
Est. primary completion date | May 31, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 10 Months to 36 Months |
Eligibility |
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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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National Clinical Center for Neuropsychomotor Recovery for Children Dr. Nicolae Robanescu | University Hospital, Brest |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | identify the most reliable kinematic parameters | identify those joints and planes where the Standard Error of Measurement (SEM) calculated for primary outcome have values below 5 degrees. | 3 years | |
Primary | 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. | 3 years | |
Primary | 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. | 3 years | |
Secondary | 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. | 3 years | |
Secondary | 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. | 3 years |
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