Movement Analysis in Musculoskeletal Oncology: a Pilot Study (AnMov)

January 11, 2024 updated by: Regina Elena Cancer Institute
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00144
        • Recruiting
        • "Regina Elena" National Cancer Institute
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

- Inability to perform pre-post treatment assessment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Popolation
Device: Motion Analysis in Musculoskeletal Oncology
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regina Elena Cancer Institute

Collaborators

Università degli studi di Roma Foro Italico
Azienda Policlinico Umberto I

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 28, 2022

Primary Completion (Estimated)

September 28, 2024

Study Completion (Estimated)

September 28, 2024

Study Registration Dates

First Submitted

March 28, 2023

First Submitted That Met QC Criteria

June 15, 2023

First Posted (Actual)

June 26, 2023

Study Record Updates

Last Update Posted (Estimated)

January 15, 2024

Last Update Submitted That Met QC Criteria

January 11, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RS1704/22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Motion Analysis in Musculoskeletal Oncology

Clinical Trials on Motion Analysis in Musculoskeletal Oncology

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saudi Arabia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe