Genu VarumMOTOR-CHILDNCT05763901
IMU-based Assessment of Motor Control in a Population of Young Subjects With Paramorphisms and Dysmorphisms
A study of Genu Varum and Genu Valgus, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Genu Varum, Genu Valgus, Flat Feet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2021to 20 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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)
Who cannot join
- Preterm birth
- Diagnosis of pathologies compromising motor control (Infantile Cerebral Palsy, Neuromuscular Diseases, Spina Bifida, Arthrogryposis, Genetic Syndromes)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- Being tested
- Clinical tests and motor control evaluation using Inertial Measurement Units
- Medical subject headings
- Genu Varum, Genu Valgum, Flatfoot, Talipes Cavus, Clubfoot, Joint Instability, Swayback, Kyphosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical tests and motor control evaluation using Inertial Measurement UnitsDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Paramorphisms/dysmorphisms of spine and/or lower limbs | Experimental | Only one arm of patients assessed for motor competence and balance without controls Receives: Diagnostic Test: Clinical tests and motor control evaluation using Inertial Measurement Units |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation and measurement of balance
Evaluation of balance using clinical tests ( Movement ABC2).
Measured: Baseline
Evaluation and measurement motor competence
Evaluation of motor competence using clinical tests (Test of Motor Competence, ).
Measured: Baseline
Measurement of balance
Measurement of balance assessing synchronicity from data obtained with Inertial Measurement Units.
Measured: Baseline
Measurement of motor competence
Measurement motor competence assessing automaticity from data obtained with Inertial Measurement Units.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start1 Apr 2021
- Primary completion16 May 2024
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genu VarumStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05763901
- Sponsor's protocol ID
- 0004188
- Acronym
- MOTOR-CHILD
- Status last verified
- Dec 2025
- First submitted
- 14 Jul 2022
- Last updated
- 23 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Motor Control During Developmental Age in Young Patients With Paramorphisms and Dysmorphisms Using Inertial Measurement Units
- ClinicalTrials.gov ID
- NCT05763901
- Acronym / sponsor ID
- MOTOR-CHILD / 0004188
- Conditions
- Genu Varum, Genu Valgus, Flat Feet, Cavus Foot, Scoliosis Idiopathic, Varus; Talipes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 16 May 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 10 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paramorphisms/dysmorphisms of spine and/or lower limbs | Experimental | Diagnostic Test: Clinical tests and motor control evaluation using Inertial Measurement UnitsOnly one arm of patients assessed for motor competence and balance without controls |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (2 listed)
- Preterm birth
- Diagnosis of pathologies compromising motor control (Infantile Cerebral Palsy, Neuromuscular Diseases, Spina Bifida, Arthrogryposis, Genetic Syndromes)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical tests and motor control evaluation using Inertial Measurement UnitsEach 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. | Diagnostic test | Paramorphisms/dysmorphisms of spine and/or lower limbs |
Primary outcome
Evaluation and measurement of balance
Time frame: Baseline
Evaluation of balance using clinical tests ( Movement ABC2).
Evaluation and measurement motor competence
Time frame: Baseline
Evaluation of motor competence using clinical tests (Test of Motor Competence, ).
Measurement of balance
Time frame: Baseline
Measurement of balance assessing synchronicity from data obtained with Inertial Measurement Units.
Measurement of motor competence
Time frame: Baseline
Measurement motor competence assessing automaticity from data obtained with Inertial Measurement Units.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Genu Varum and Genu Valgus, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation and measurement of balance (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.