Motion Analysis in Musculoskeletal OncologyAnMovNCT05918549
Movement Analysis in Musculoskeletal Oncology: a Pilot Study
An observational study of Motion Analysis in Musculoskeletal Oncology, run by Regina Elena Cancer Institute at 1 site in Italy.
Trial summary
Noninterventional, prospective, multicenter pilot study of patients with primary and secondary musculoskeletal tumors designed to investigate functional outcomes after therapy using both subjective and quantitative motion detection techniques Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Motion Analysis in Musculoskeletal Oncology
- What is being tested?
- Motion Analysis in Musculoskeletal Oncology
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 28 Sep 2022to 28 Sep 2024
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with primary and secondary cancers of the musculoskeletal system with estimated survival greater than one year who are candidates for bone resection surgery or wide excision of soft tissue lesion and/or radio and chemotherapy treatments
Who may be able to join
- Age > 6 years
- Diagnosis of primary and secondary tumors of the musculoskeletal system
- Patients who will need to undergo surgery for bone resection or wide excision of soft tissue lesion, and/or radiation or drug treatments
- Availability of follow-up data (for at least 6 months)
- Written informed consent
Who cannot join
- Inability to perform pre-post treatment assessment
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
"Regina Elena" National Cancer Institute
Rome, 00144
Roberto Biagini, MD, ND, roberto.biagini@ifo.it
About this study
Noninterventional, prospective, multicenter pilot study of patients with primary and secondary musculoskeletal tumors designed to investigate functional outcomes after therapy using both subjective and quantitative motion detection techniques
- Being tested
- Motion Analysis in Musculoskeletal Oncology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motion Analysis in Musculoskeletal OncologyDevice
Noninterventional, prospective, multicenter pilot study of patients with primary and secondary musculoskeletal tumors designed to investigate functional outcomes after therapy using both subjective and quantitative motion detection techniques
| Study group | Role | What they receive |
|---|---|---|
| Popolation | Not described Receives: Device: Motion Analysis in Musculoskeletal Oncology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life
To investigate any differences found using the two methods (quantitative/movement analysis technique versus "subjective"/qualitative technique) in changes in walking/motor characteristics in post-treatment versus pre-treatment.
Patients will be monitored via a system of wearable sensors (OPAL 15) which send signals to a computer - station receiving. The system is equipped with 15 small, wireless devices and non-invasive, which contain the following sensors:
- triaxial accelerometer for measuring linear accelerations of the body segment; ii) triaxial gyroscope for measuring angular speeds; iii) triaxial magnetometer, essential for estimating the orientation of the segment in space corporeal. The system synchronously acquires data from each device and sends it via telemetry to one control unit that collects them and saves them in the local database of the computer used for the acquisition.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start28 Sep 2022
- Primary completion28 Sep 2024 (estimated)
- Study completion28 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motion Analysis in Musculoskeletal OncologyStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regina Elena Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Policlinico Umberto I, Università degli studi di Roma Foro Italico
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05918549
- Sponsor's protocol ID
- RS1704/22
- Acronym
- AnMov
- Status last verified
- Jan 2024
- First submitted
- 28 Mar 2023
- Last updated
- 16 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Movement Analysis in Musculoskeletal Oncology: a Pilot Study
- ClinicalTrials.gov ID
- NCT05918549
- Acronym / sponsor ID
- AnMov / RS1704/22
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Regina Elena Cancer InstituteUniversity, hospital or other
- Collaborators
- Azienda Policlinico Umberto I, Università degli studi di Roma Foro Italico
- Study start
- 28 Sep 2022 (actual)
- Primary completion
- 28 Sep 2024 (estimated)
- Study completion
- 28 Sep 2024 (estimated)
- First posted
- 26 Jun 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.
Noninterventional, prospective, multicenter pilot study of patients with primary and secondary musculoskeletal tumors designed to investigate functional outcomes after therapy using both subjective and quantitative motion detection techniques
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Popolation | – | Device: Motion Analysis in Musculoskeletal Oncology |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with primary and secondary cancers of the musculoskeletal system with estimated survival greater than one year who are candidates for bone resection surgery or wide excision of soft tissue lesion and/or radio and chemotherapy treatments
Key inclusion criteria (5 listed)
- Age > 6 years
- Diagnosis of primary and secondary tumors of the musculoskeletal system
- Patients who will need to undergo surgery for bone resection or wide excision of soft tissue lesion, and/or radiation or drug treatments
- Availability of follow-up data (for at least 6 months)
- Written informed consent
Key exclusion criteria (1 listed)
- Inability to perform pre-post treatment assessment
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 |
|---|---|---|
| Motion Analysis in Musculoskeletal OncologyNoninterventional, prospective, multicenter pilot study of patients with primary and secondary musculoskeletal tumors designed to investigate functional outcomes after therapy using both subjective and quantitative motion detection techniques | Device | Popolation |
Primary outcome
Quality of life
Time frame: Baseline
To investigate any differences found using the two methods (quantitative/movement analysis technique versus "subjective"/qualitative technique) in changes in walking/motor characteristics in post-treatment versus pre-treatment. Patients will be monitored via a system of wearable sensors (OPAL 15) which send signals to a computer - station receiving. The system is equipped with 15 small, wireless devices and non-invasive, which contain the following sensors: i) triaxial accelerometer for measuring linear accelerations of the body segment; ii) triaxial gyroscope for measuring angular speeds; iii) triaxial magnetometer, essential for estimating the orientation of the segment in space corporeal. The system synchronously acquires data from each device and sends it via telemetry to one control unit that collects them and saves them in the local database of the computer used for the acquisition.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2024.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Motion Analysis in Musculoskeletal Oncology, run by Regina Elena Cancer Institute 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 5 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 16 Jan 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life (time frame: Baseline). 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 16 Jan 2024.