Movement Analysis in Musculoskeletal Oncology: a Pilot Study

NCT05918549 | Unknown

• 1 other identifier: RS1704/22
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Motion Analysis in Musculoskeletal Oncology

Outcome Measures

Primary Outcomes (1)

• 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: 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

Study Arms (1)

Popolation

Device: Motion Analysis in Musculoskeletal Oncology

Interventions

Motion Analysis in Musculoskeletal Oncology DEVICE

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

Popolation

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• \- Inability to perform pre-post treatment assessment

Sponsors & Collaborators

• Regina Elena Cancer Institute: lead
• Azienda Policlinico Umberto I: collaborator
• Università degli studi di Roma Foro Italico: collaborator

Study Sites (1)

"Regina Elena" National Cancer Institute

Rome, 00144, Italy

RECRUITING

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2023
• First Posted: June 26, 2023
• Study Start: September 28, 2022
• Primary Completion: September 28, 2024
• Study Completion: September 28, 2024
• Last Updated: January 16, 2024

Record last verified: 2024-01

Locations

IT (1)