MOTOR-CHILD: IMU-based Assessment of Motor Control in a Population of Young Subjects With Paramorphisms and Dysmorphisms

Sponsor

Istituto Ortopedico Rizzoli (Other)

Overall Status

Recruiting

CT.gov ID

NCT05763901

Collaborator

(none)

180

Enrollment

Location

Arm

Anticipated Duration (Months)

6.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Genu Varum Genu Valgus Flat Feet Cavus Foot Scoliosis Idiopathic Varus; Talipes Valgus, Talipes Laxity of Ligament Hyperlordosis Hyperkyphosis Angular Limb Deformity	Diagnostic Test: Clinical tests and motor control evaluation using Inertial Measurement Units	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

180 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Apr 1, 2021

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Paramorphisms/dysmorphisms of spine and/or lower limbs Only one arm of patients assessed for motor competence and balance without controls	Diagnostic Test: Clinical tests and motor control evaluation using Inertial Measurement Units Each patient is evaluated using clinical tests (Movement ABC2, Test of Motor Competence), a screening questionnaire (DCD-Q), and wearable Inertial Measurement Units to assess balance and motor control during a Natural Walking and Tandem Walking test.

Arm

Intervention/Treatment

Experimental: Paramorphisms/dysmorphisms of spine and/or lower limbs

Only one arm of patients assessed for motor competence and balance without controls

Diagnostic Test: Clinical tests and motor control evaluation using Inertial Measurement Units

Each patient is evaluated using clinical tests (Movement ABC2, Test of Motor Competence), a screening questionnaire (DCD-Q), and wearable Inertial Measurement Units to assess balance and motor control during a Natural Walking and Tandem Walking test.

Outcome Measures

Primary Outcome Measures

Evaluation and measurement of balance [Baseline]
Evaluation of balance using clinical tests ( Movement ABC2).
Evaluation and measurement motor competence [Baseline]
Evaluation of motor competence using clinical tests (Test of Motor Competence, ).
Measurement of balance [Baseline]
Measurement of balance assessing synchronicity from data obtained with Inertial Measurement Units.
Measurement of motor competence [Baseline]
Measurement motor competence assessing automaticity from data obtained with Inertial Measurement Units.

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)