Soft Tissue Sarcoma: Instrumented Evaluation of Motor Performance and Impact of Robotic Rehabilitation, Nutrition and Quality of Life Assessment (START-RUN1)

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• patient with primary and localized STS who is a candidate for limb-sparing surgery or retroperitoneal multivisceral resection (including partial or complete resection of the iliopsoas muscle with functional loss and potential femoral nerve involvement) with curative intent;

• age 18 years or older.

Locations
Other Locations
Italy
Istituto Nazionale Tumori-IRCCS-Fondazione G.Pascale
NOT_YET_RECRUITING
Napoli
Fondazione Don Carlo Gnocchi ONLUS
ACTIVE_NOT_RECRUITING
Roma
Fondazione Policlinico Universitario Campus Bio-Medico
RECRUITING
Rome
Contact Information
Primary
Bruno Vincenzi
b.vincenzi@policlinicocampus.it
+3906225411160
Time Frame
Start Date: 2025-03-13
Estimated Completion Date: 2026-08-31
Participants
Target number of participants: 120
Treatments
Experimental: Rehabilitation
Conventional and robotic / technological rehabilitation treatments targeting the upper or lower limb, based on tumor location.
Related Therapeutic Areas
Sponsors
Collaborators: Fondazione Don Carlo Gnocchi Onlus, Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale
Leads: Fondazione Policlinico Universitario Campus Bio-Medico

This content was sourced from clinicaltrials.gov