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

Scoliosis Idiopathic Clinical Trial

— MOTOR-CHILD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05763901
• Other study ID #: 0004188
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: July 18, 2024

Study information

• Verified date: May 2024
• Source: Istituto Ortopedico Rizzoli
• Contact: Giuseppina Mariagrazia Farella, MD
• Phone: +39 051 6366359
• Email: giuseppinamariagrazia.farella[@]ior.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: July 18, 2024
• Est. primary completion date: July 18, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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)

Related Conditions & MeSH terms

• Clubfoot
• Equinus Deformity
• Flat Feet
• Flatfoot
• Genu Valgus
• Genu Varum
• Hyperkyphosis
• Kyphosis
• Scoliosis
• Scoliosis Idiopathic

Intervention

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.

Locations

Country	Name	City	State
Italy	IRCCS-Istituto Ortopedico Rizzoli	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation and measurement of balance	Evaluation of balance using clinical tests ( Movement ABC2).	Baseline
Primary	Evaluation and measurement motor competence	Evaluation of motor competence using clinical tests (Test of Motor Competence, ).	Baseline
Primary	Measurement of balance	Measurement of balance assessing synchronicity from data obtained with Inertial Measurement Units.	Baseline
Primary	Measurement of motor competence	Measurement motor competence assessing automaticity from data obtained with Inertial Measurement Units.	Baseline