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

Primary Purpose

Genu Varum, Genu Valgus, Flat Feet

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Clinical tests and motor control evaluation using Inertial Measurement Units
Sponsored by
Istituto Ortopedico Rizzoli
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Genu Varum

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • IRCCS-Istituto Ortopedico RizzoliRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Paramorphisms/dysmorphisms of spine and/or lower limbs

Arm Description

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

Outcomes

Primary Outcome Measures

Evaluation and measurement of balance
Evaluation of balance using clinical tests ( Movement ABC2).
Evaluation and measurement motor competence
Evaluation of motor competence using clinical tests (Test of Motor Competence, ).
Measurement of balance
Measurement of balance assessing synchronicity from data obtained with Inertial Measurement Units.
Measurement of motor competence
Measurement motor competence assessing automaticity from data obtained with Inertial Measurement Units.

Secondary Outcome Measures

Full Information

First Posted
July 14, 2022
Last Updated
May 12, 2023
Sponsor
Istituto Ortopedico Rizzoli
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1. Study Identification

Unique Protocol Identification Number
NCT05763901
Brief Title
IMU-based Assessment of Motor Control in a Population of Young Subjects With Paramorphisms and Dysmorphisms
Acronym
MOTOR-CHILD
Official Title
Evaluation of Motor Control During Developmental Age in Young Patients With Paramorphisms and Dysmorphisms Using Inertial Measurement Units
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istituto Ortopedico Rizzoli

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Genu Varum, Genu Valgus, Flat Feet, Cavus Foot, Scoliosis Idiopathic, Varus; Talipes, Valgus, Talipes, Laxity of Ligament, Hyperlordosis, Hyperkyphosis, Angular Limb Deformity

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Paramorphisms/dysmorphisms of spine and/or lower limbs
Arm Type
Experimental
Arm Description
Only one arm of patients assessed for motor competence and balance without controls
Intervention Type
Diagnostic Test
Intervention Name(s)
Clinical tests and motor control evaluation using Inertial Measurement Units
Intervention Description
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.
Primary Outcome Measure Information:
Title
Evaluation and measurement of balance
Description
Evaluation of balance using clinical tests ( Movement ABC2).
Time Frame
Baseline
Title
Evaluation and measurement motor competence
Description
Evaluation of motor competence using clinical tests (Test of Motor Competence, ).
Time Frame
Baseline
Title
Measurement of balance
Description
Measurement of balance assessing synchronicity from data obtained with Inertial Measurement Units.
Time Frame
Baseline
Title
Measurement of motor competence
Description
Measurement motor competence assessing automaticity from data obtained with Inertial Measurement Units.
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Giuseppina Mariagrazia Farella, MD
Phone
+39 051 6366359
Email
giuseppinamariagrazia.farella@ior.it
Facility Information:
Facility Name
IRCCS-Istituto Ortopedico Rizzoli
City
Bologna
ZIP/Postal Code
40136
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Grazia Benedetti, MD
Phone
+390516366236
Email
mariagrazia.benedetti@ior.it

12. IPD Sharing Statement

Learn more about this trial

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

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