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

NCT05763901 | Completed

• 1 other identifier: 0004188
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• Evaluation and measurement of balance

  Evaluation of balance using clinical tests ( Movement ABC2).

  Baseline

• Evaluation and measurement motor competence

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

  Baseline

• Measurement of balance

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

  Baseline

• Measurement of motor competence

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

  Baseline

Study Arms (1)

Paramorphisms/dysmorphisms of spine and/or lower limbs

EXPERIMENTAL

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

Interventions

Clinical tests and motor control evaluation using Inertial Measurement Units 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.

Paramorphisms/dysmorphisms of spine and/or lower limbs

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

IRCCS-Istituto Ortopedico Rizzoli

Bologna, 40136, Italy

Location

MeSH Terms

Conditions

Genu Varum; Genu Valgum; Flatfoot; Talipes Cavus; Clubfoot; Joint Instability; Swayback; Kyphosis

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Talipes; Foot Deformities, Acquired; Foot Deformities; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Joint Diseases; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Sheep Diseases; Animal Diseases; Spinal Curvatures; Spinal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2022
• First Posted: March 10, 2023
• Study Start: April 1, 2021
• Primary Completion: May 16, 2024
• Study Completion: December 20, 2024
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

IT (1)