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

NCT04559776 | Completed

• 1 other identifier: 8463/2016
• Study Type: interventional
• Target: 41
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Gait, Spastic; Reliability

Keywords

toddlers; 3D motion analysis; EMG; reliability

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• sources of variability for kinematics

  3 years

• sources of variability for EMG

  3 years

Other Outcomes (1)

• identify the most reliable kinematic parameters

  3 years

Study Arms (2)

typically developing toddlers

EXPERIMENTAL

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

Other: gait analysis

unilateral cerebral palsy toddlers

EXPERIMENTAL

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

Other: gait analysis

Interventions

gait analysis OTHER

gait analysis with 3D optoelectronic system and surface EMG

typically developing toddlers; unilateral cerebral palsy toddlers

Eligibility Criteria

• Age: 10 Months - 36 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• up to 3 years of age,
• maximum independent walking experience of 6 months, and

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Clinical Center for Neuropsychomotor Recovery for Children Dr. Nicolae Robanescu: lead
• University Hospital, Brest: collaborator

MeSH Terms

Conditions

Gait Disorders, Neurologic

Interventions

Gait Analysis

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Gait; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Physical Functional Performance; Physical Fitness; Health; Population Characteristics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: September 1, 2020
• First Posted: September 23, 2020
• Study Start: January 5, 2016
• Primary Completion: May 31, 2018
• Study Completion: December 31, 2018
• Last Updated: September 23, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share