- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05763901
IMU-based Assessment of Motor Control in a Population of Young Subjects With Paramorphisms and Dysmorphisms (MOTOR-CHILD)
Evaluation of Motor Control During Developmental Age in Young Patients With Paramorphisms and Dysmorphisms Using Inertial Measurement Units
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Bologna, Italy, 40136
- IRCCS-Istituto Ortopedico Rizzoli
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Paramorphisms/dysmorphisms of spine and/or lower limbs
Only one arm of patients assessed for motor competence and balance without controls
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluation and measurement of balance
Time Frame: Baseline
|
Evaluation of balance using clinical tests ( Movement ABC2).
|
Baseline
|
|
Evaluation and measurement motor competence
Time Frame: Baseline
|
Evaluation of motor competence using clinical tests (Test of Motor Competence, ).
|
Baseline
|
|
Measurement of balance
Time Frame: Baseline
|
Measurement of balance assessing synchronicity from data obtained with Inertial Measurement Units.
|
Baseline
|
|
Measurement of motor competence
Time Frame: Baseline
|
Measurement motor competence assessing automaticity from data obtained with Inertial Measurement Units.
|
Baseline
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Talipes
- Bone Diseases
- Musculoskeletal Diseases
- Nutrition Disorders
- Joint Diseases
- Spinal Diseases
- Musculoskeletal Abnormalities
- Congenital Abnormalities
- Deficiency Diseases
- Malnutrition
- Spinal Curvatures
- Lower Extremity Deformities, Congenital
- Limb Deformities, Congenital
- Foot Deformities
- Foot Deformities, Acquired
- Foot Deformities, Congenital
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
- Nutritional and Metabolic Diseases
- Animal Diseases
- Sheep Diseases
- Talipes Cavus
- Kyphosis
- Flatfoot
- Swayback
- Joint Instability
- Clubfoot
- Genu Varum
- Genu Valgum
Other Study ID Numbers
- 0004188
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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