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

NCT05763901 — Not applicable, Completed, 151 participants, Istituto Ortopedico Rizzoli

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

Registry	NCT05763901, acronym MOTOR-CHILD
Status	Completed
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, diagnostic
Enrollment	151 (Actual)
Sponsor	Istituto Ortopedico Rizzoli (Other)
Conditions	Genu Varum, Genu Valgus, Flat Feet, Cavus Foot, Scoliosis Idiopathic, Varus; Talipes, Valgus, Talipes, Laxity of Ligament, Hyperlordosis, Hyperkyphosis, Angular Limb Deformity
Interventions	Clinical tests and motor control evaluation using Inertial Measurement Units (Diagnostic test)
Dates	start 2021-04-01, primary completion 2024-05-16, completion 2024-12-20, first posted 2023-03-10, last updated 2025-12-23
Locations	1 site in Italy

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Paramorphisms/dysmorphisms of spine and/or lower limbs	Experimental	Diagnostic Test: Clinical tests and motor control evaluation using Inertial Measurement Units	Only one arm of patients assessed for motor competence and balance without controls

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.

+Outcome measures

Primary outcomes

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

Sex: All, ages: 6 Years to 17 Years

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)

+Locations (1)

Facility	City	Country	Status
IRCCS-Istituto Ortopedico Rizzoli	Bologna	Italy