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

NCT ID: NCT05763901

Last Updated: 2025-12-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 151 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2024-12-20

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.

Conditions

Genu Varum; Genu Valgus; Flat Feet; Cavus Foot; Scoliosis Idiopathic; Varus; Talipes; Valgus, Talipes; Laxity of Ligament; Hyperlordosis; Hyperkyphosis; Angular Limb Deformity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Paramorphisms/dysmorphisms of spine and/or lower limbs

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

Group Type: EXPERIMENTAL

Clinical tests and motor control evaluation using Inertial Measurement Units

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

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)

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituto Ortopedico Rizzoli

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

IRCCS-Istituto Ortopedico Rizzoli

Bologna, , Italy

Countries

Italy

Other Identifiers

0004188

Identifier Type: -

Identifier Source: org_study_id