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

Not Applicable

Recruiting

• Conditions: Flat Feet; Genu Varum; Scoliosis Idiopathic; Valgus, Talipes; Laxity of Ligament; Hyperlordosis; Varus; Talipes; Genu Valgus; Cavus Foot; Hyperkyphosis
• Interventions: Diagnostic Test: Clinical tests and motor control evaluation using Inertial Measurement Units

• Registration Number: NCT05763901
• Lead Sponsor: Istituto Ortopedico Rizzoli

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-01
• Study First Submitted: 2022-07-14
• Study First Submitted QC: 2023-02-28
• Study First Posted: 2023-03-10
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-15
• Last Update Posted: 2025-01-16
• Primary Completion: 2025-10-18
• Study Completion: 2025-10-18

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Paramorphisms/dysmorphisms of spine and/or lower limbs	Clinical tests and motor control evaluation using Inertial Measurement Units	Only one arm of patients assessed for motor competence and balance without controls

Primary Outcome Measures

Name	Time	Method
Measurement of balance	Baseline	Measurement of balance assessing synchronicity from data obtained with Inertial Measurement Units.
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 motor competence	Baseline	Measurement motor competence assessing automaticity from data obtained with Inertial Measurement Units.

Trial Locations

Locations (1)

IRCCS-Istituto Ortopedico Rizzoli; 🇮🇹 Bologna, Italy