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Clinical Trials/NCT05763901
NCT05763901
Completed
N/A

Evaluation of Motor Control During Developmental Age in Young Patients With Paramorphisms and Dysmorphisms Using Inertial Measurement Units

Istituto Ortopedico Rizzoli1 site in 1 country151 target enrollmentApril 1, 2021

Overview

Phase
N/A
Intervention
Not specified
Conditions
Genu Varum
Sponsor
Istituto Ortopedico Rizzoli
Enrollment
151
Locations
1
Primary Endpoint
Evaluation and measurement of balance
Status
Completed
Last Updated
4 months ago

Overview

Brief Summary

While various complex pathologies of the developmental age, such as Infantile Cerebral Palsy or Neuromuscular Diseases, are notoriously considered causes of alteration of locomotor development, it is scarcely known whether conditions much more frequent in the pediatric population, the so-called "Paramorphisms or Dysmorphisms", may be associated with more or less noticeable changes in locomotor development.

On a few studies, flat feet and hyperlaxity has been correlated with a motor control delay or poorer motor performance, based on complex clinical tests or on stereophotogrammetry movement analysis.

Although promising, these preliminary studies, in addition to not providing information on the possible influence of other paramorphisms, such as varus and valgus of the knees, do not provide conclusive indications.

The aim of this study is to investigate, through clinical tests and wearable inertial units, the motor control of a pediatric population affected by Paramorphisms or Dysmorphisms and to compare them with a population of healthy controls, matched by age, taken from the recently developed control data set from Bisi and Stagni.

Registry
clinicaltrials.gov
Start Date
April 1, 2021
End Date
December 20, 2024
Last Updated
4 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Born at term
  • Without known delay in motor development
  • Finding of one or more paramorphisms or dysmorphisms of the developmental age (flat or cavus foot, valgus or varus talipes, valgus or varus knee, scoliotic attitude or scoliosis, hyperkyphosis or hyperlordosis, generalized or focused hyperlaxity, heterometry of the AAII, torsional defects AAII)

Exclusion Criteria

  • Preterm birth
  • Diagnosis of pathologies compromising motor control (Infantile Cerebral Palsy, Neuromuscular Diseases, Spina Bifida, Arthrogryposis, Genetic Syndromes)

Outcomes

Primary Outcomes

Evaluation and measurement of balance

Time Frame: Baseline

Evaluation of balance using clinical tests ( Movement ABC2).

Evaluation and measurement motor competence

Time Frame: Baseline

Evaluation of motor competence using clinical tests (Test of Motor Competence, ).

Measurement of balance

Time Frame: Baseline

Measurement of balance assessing synchronicity from data obtained with Inertial Measurement Units.

Measurement of motor competence

Time Frame: Baseline

Measurement motor competence assessing automaticity from data obtained with Inertial Measurement Units.

Study Sites (1)

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