Spine DiseaseNCT06400680
Gait Spine Functional Evaluation Protocol
A study testing Spine Kinematic Assessment with Optoelectronic system in people with Spine Disease and Gait, run by IRCCS Eugenio Medea at 1 site in Italy.
Trial summary
The goal of this clinical trial is to develop and validate of a new protocol for multifactorial functional assessment of the kinematics of spinal and total body movements during walking by means of the optoelectronic motion analysis system in healthy and scoliosis subjects. Read more about this study
- Who is it for?
- Ages 5 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Spine Disease, Gait
- What is being tested?
- Spine Kinematic Assessment with Optoelectronic system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 18 May 2023to 18 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 5 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- no history of low back pain or spine related pathology
- Diagnosis of idiopathic scoliosis
- Autonomous gait
Who cannot join
- motor impairments during gait
- For scoliosis group:
- motor impairments during gait
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of New Multifactorial Functional Evaluation Protocols and Related Indices for the Pediatric Age - Gait Spine Evaluation Protocol
The goal of this clinical trial is to develop and validate of a new protocol for multifactorial functional assessment of the kinematics of spinal and total body movements during walking by means of the optoelectronic motion analysis system in healthy and scoliosis subjects.
The main questions it aims to answer are:
- Is feasibility developing a protocol to assess the spine kinematic during walking?
- Is the intra and inter operator reliability of the developed protocol acceptable?
- Is the usability of the developed protocol acceptable? During data acquisition a trained therapist placed reflective markers on the skin of the participants in the selected body landmarks. The participants will be asked to perform five trial of walking barefoot on a 6 meters distance at a self-selected normal-pace speed, for each session.
Read the detailed description
The spine is the central supporting structure of the body and for the torso in particular, allowing for flexibility and shock absorption, as well as routing and protecting the spinal cord and supporting the head and upper limbs for sensory and motor functions. In this perspective the evaluation of its movements in a global and segmental contribution is of paramount importance and cannot be separated by the other tasks. The locomotor function was the first one targeted by human motion analysis and still represent the main application in the rehabilitation. Optoelectronic systems are the gold standard technique for this assessment and specific protocols are available and applied. Traditional stereophotogrammetric models were used to assess the kinematics of pelvis, hip, knee, ankle, trunk (considered as a single rigid segment that does not provide information on kinematic changes within the spine). Indeed, it is relevant to understand the integrated and synergic motion of the spine and other body segment for a variety of applications, such as clinical diagnosis, endoprosthesis design, and the evaluation of treatment outcomes. Therefore, an accurate trunk motion analysis may be useful during medical diagnostic-therapeutic process. The aim of this study is introducing a new protocol consisting of a marker set, i.e. an innovative and integrated biomechanical model of the human body for the global analysis of spine and body movement during gait allows for a more detailed evaluation of the motor behavior and its abnormalities to better characterize the functionality of the spine at the level of its three main segments (upper thoracic, lower thoracic and lumbar), both on the sagittal, frontal and transversal plane, during walking. The development of a new protocol of analysis requires the validation before its definitive and clinical application. More in detail, the validation should be carried out in terms of both comparisons with reference absolute measures and the evaluation of its repeatability with healthy subjects.
- Conditions
- Spine Disease, Gait
- Being tested
- Spine Kinematic Assessment with Optoelectronic system
- Keywords
- Spine Kinematics, Thoracic Spine, Lumbar Spine, Motion analysis
- Medical subject headings
- Spinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spine Kinematic Assessment with Optoelectronic systemDevice
All measurements will be obtained using an optoelectronic multicamera system for human motion analysis (with eight high-resolution cameras with infrared light and a sampling frequency of 100 Hz.
The experimental protocol require the positioning of markers (plastic spheres covered by reflecting film). Markers will be placed by clinical operators (physiotherapists with training in optoelectronic system for human motion analysis) after training and experience in recognition of the position of spinous and transversal processes, by manual identification.
During the data acquisition protocol, the subject perform five trial of walking barefoot on a 6 m distance at a self-selected normal-pace speed.
Every subject repeated this operations 2 times with 2 different operators.
| Study group | Role | What they receive |
|---|---|---|
| Healthy subjects | Experimental | Subjects without spine disease Receives: Device: Spine Kinematic Assessment with Optoelectronic system |
| Scoliotic subjects | Experimental | Subjects with a scoliosis diagnosis Receives: Device: Spine Kinematic Assessment with Optoelectronic system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra/Inter Operator Reliability
In the intra and interoperator repeatability analysis the investigators considered the correlation coefficient for the average RoM (in the 5 trials) in corresponding sessions. In particular, the investigators referred to standard interpretation criteria: the ICC values 0.5 and 0.75 indicate moderate reliability, values between 0.75 and 0.9 indicate good reliability, and values greater than, 0.90 indicate excellent reliability.
Intra and inter operator reliability will be calculated at the achievement of ten healthy subjects ( during the first year), and then at the achievement of ten scoliotic subjects (during the second year)
Measured: Through study completion, an average of 3 year
Root mean square error as measure of accuracy
For the accuracy analysis, the comparison between the reference measures and the measure obtained with the optoelectronic system for every segment of the spine assessed through the root mean square error
Measured: Year 1
SUS questionnaire score for usability assessment
About the usability assessment, the System Usability Scale (SUS) collected at the end of each acquisition and calculated the average score value. The SUS provides a reliable tool for measuring the usability. The SUS questionnaire consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree
Measured: Through study completion, an average of 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start18 May 2023
- Primary completion18 May 2026 (estimated)
- Study completion18 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine DiseaseStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Eugenio Medea
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giuseppe Andreoni, Principal investigator, IRCCS E. Medea - La Nostra Famiglia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06400680
- Sponsor's protocol ID
- 1053
- Status last verified
- Mar 2026
- First submitted
- 19 Mar 2024
- Last updated
- 14 Apr 2026
- 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 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of New Multifactorial Functional Evaluation Protocols and Related Indices for the Pediatric Age - Gait Spine Evaluation Protocol
- ClinicalTrials.gov ID
- NCT06400680
- Acronym / sponsor ID
- 1053
- Conditions
- Spine Disease, Gait
- Keywords
- Spine Kinematics, Thoracic Spine, Lumbar Spine, Motion analysis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (actual)
- Lead sponsor
- IRCCS Eugenio MedeaUniversity, hospital or other
- Study start
- 18 May 2023 (actual)
- Primary completion
- 18 May 2026 (estimated)
- Study completion
- 18 May 2026 (estimated)
- First posted
- 6 May 2024 (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.
The goal of this clinical trial is to develop and validate of a new protocol for multifactorial functional assessment of the kinematics of spinal and total body movements during walking by means of the optoelectronic motion analysis system in healthy and scoliosis subjects.
The main questions it aims to answer are:
- Is feasibility developing a protocol to assess the spine kinematic during walking?
- Is the intra and inter operator reliability of the developed protocol acceptable?
- Is the usability of the developed protocol acceptable? During data acquisition a trained therapist placed reflective markers on the skin of the participants in the selected body landmarks. The participants will be asked to perform five trial of walking barefoot on a 6 meters distance at a self-selected normal-pace speed, for each session.
Detailed description
The spine is the central supporting structure of the body and for the torso in particular, allowing for flexibility and shock absorption, as well as routing and protecting the spinal cord and supporting the head and upper limbs for sensory and motor functions. In this perspective the evaluation of its movements in a global and segmental contribution is of paramount importance and cannot be separated by the other tasks. The locomotor function was the first one targeted by human motion analysis and still represent the main application in the rehabilitation. Optoelectronic systems are the gold standard technique for this assessment and specific protocols are available and applied. Traditional stereophotogrammetric models were used to assess the kinematics of pelvis, hip, knee, ankle, trunk (considered as a single rigid segment that does not provide information on kinematic changes within the spine). Indeed, it is relevant to understand the integrated and synergic motion of the spine and other body segment for a variety of applications, such as clinical diagnosis, endoprosthesis design, and the evaluation of treatment outcomes. Therefore, an accurate trunk motion analysis may be useful during medical diagnostic-therapeutic process. The aim of this study is introducing a new protocol consisting of a marker set, i.e. an innovative and integrated biomechanical model of the human body for the global analysis of spine and body movement during gait allows for a more detailed evaluation of the motor behavior and its abnormalities to better characterize the functionality of the spine at the level of its three main segments (upper thoracic, lower thoracic and lumbar), both on the sagittal, frontal and transversal plane, during walking. The development of a new protocol of analysis requires the validation before its definitive and clinical application. More in detail, the validation should be carried out in terms of both comparisons with reference absolute measures and the evaluation of its repeatability with healthy subjects.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy subjects | Experimental | Device: Spine Kinematic Assessment with Optoelectronic systemSubjects without spine disease |
| Scoliotic subjects | Experimental | Device: Spine Kinematic Assessment with Optoelectronic systemSubjects with a scoliosis diagnosis |
Who may qualify
- Ages
- 5 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- no history of low back pain or spine related pathology
- Diagnosis of idiopathic scoliosis
- Autonomous gait
Key exclusion criteria (3 listed)
- motor impairments during gait
- motor impairments during gait
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 |
|---|---|---|
| Spine Kinematic Assessment with Optoelectronic systemAll measurements will be obtained using an optoelectronic multicamera system for human motion analysis (with eight high-resolution cameras with infrared light and a sampling frequency of 100 Hz. The experimental protocol require the positioning of markers (plastic spheres covered by reflecting film). Markers will be placed by clinical operators (physiotherapists with training in optoelectronic system for human motion analysis) after training and experience in recognition of the position of spinous and transversal processes, by manual identification. During the data acquisition protocol, the subject perform five trial of walking barefoot on a 6 m distance at a self-selected normal-pace speed. Every subject repeated this operations 2 times with 2 different operators. | Device | Healthy subjects, Scoliotic subjects |
Primary outcome
Intra/Inter Operator Reliability
Time frame: Through study completion, an average of 3 year
In the intra and interoperator repeatability analysis the investigators considered the correlation coefficient for the average RoM (in the 5 trials) in corresponding sessions. In particular, the investigators referred to standard interpretation criteria: the ICC values 0.5 and 0.75 indicate moderate reliability, values between 0.75 and 0.9 indicate good reliability, and values greater than, 0.90 indicate excellent reliability. Intra and inter operator reliability will be calculated at the achievement of ten healthy subjects ( during the first year), and then at the achievement of ten scoliotic subjects (during the second year)
Root mean square error as measure of accuracy
Time frame: Year 1
For the accuracy analysis, the comparison between the reference measures and the measure obtained with the optoelectronic system for every segment of the spine assessed through the root mean square error
SUS questionnaire score for usability assessment
Time frame: Through study completion, an average of 3 year
About the usability assessment, the System Usability Scale (SUS) collected at the end of each acquisition and calculated the average score value. The SUS provides a reliable tool for measuring the usability. The SUS questionnaire consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
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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.
Giuseppe Andreoni principal investigator
IRCCS E. Medea - La Nostra Famiglia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spine Kinematic Assessment with Optoelectronic system in people with Spine Disease and Gait, run by IRCCS Eugenio Medea 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 3 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: under way, not looking for participants, as of the sponsor's last update on 14 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Intra/Inter Operator Reliability (time frame: Through study completion, an average of 3 year). The study lists 3 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 14 Apr 2026.