Clinical Trial

Soft Tissue Sarcoma: Motor Performance, Robotic Rehabilitation, Nutrition, and Quality of Life

Study acronym: START-RUN1
Recruiting
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Record status
This record was last updated March 21, 2025 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.
Summary
Soft tissue sarcomas are a group of rare and heterogeneous tumors. Surgery is the mainstay of treatment and microscopic negative margins need to be achieved to improve disease local control. We designed this prospective study to evaluate the main features of motor impairment and the impact of tailored robotic rehabilitation techniques in patients treated for localized soft tissue sarcoma (surgery alone, or surgery + radiation or radiochemotherapy). Specific patients' motor strategies will be quantitatively measured through a biomechanical assessment, including the analysis of joint kinematics, and muscle activity timing patterns. Considering the influence of motor impairment after demolitive surgery, a major interest of this study will be focused on nutrition and Quality of life which will be prospectively evaluated by specific questionnaires at different time points.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-03-11.
Status change: Not Yet Recruiting → Recruiting 2025-03-19
Trial Details
NCT Number NCT06873685
Lead Sponsor Fondazione Policlinico Universitario Campus Bio-Medico
Collaborators: Fondazione Don Carlo Gnocchi ETS, Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale
Conditions Sarcoma, Soft Tissue
Enrollment 120 participants
Start Date 2025-03-13
Primary Completion 2025-12-31 (estimated)
Study Completion 2026-08-31 (estimated)
Updated on ClinicalTrials.gov 2025-03-21