Movement Analysis in Musculoskeletal Oncology: a Pilot Study

Recruiting

• Conditions: Motion Analysis in Musculoskeletal Oncology
• Interventions: Device: Motion Analysis in Musculoskeletal Oncology

• Registration Number: NCT05918549
• Lead Sponsor: Regina Elena Cancer Institute

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-28
• Study First Submitted: 2023-03-28
• Study First Submitted QC: 2023-06-15
• Study First Posted: 2023-06-26
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-11
• Last Update Posted: 2024-01-16
• Primary Completion: 2024-09-28
• Study Completion: 2024-09-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Popolation	Motion Analysis in Musculoskeletal Oncology	-

Primary Outcome Measures

Name	Time	Method
Quality of life	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.

Trial Locations

Locations (1)

"Regina Elena" National Cancer Institute; 🇮🇹 Rome, Italy