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.
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.
recurrent tumors;
metastatic disease;
candidate for palliative and non-radical surgery;
refusal to sign informed consent;
Single group
Rehabilitation
Other interventionAfter surgery, patients will undergo a personalized rehabilitation program incorporating both conventional and robotic-based approaches. Depending on tumor location, rehabilitation will focus on either the upper or lower limbs. For lower limb rehabilitation, robotic or technological devices will be utilized for gait training with bodyweight support, as well as for balance and proprioception training. Upper limb rehabilitation will involve robotic or sensor-based devices enabling passive, active, and active-assistive movements of the shoulder, elbow, and hand. Treatment will be provided in various settings- inpatient, outpatient, or home-based- tailored to each patient's specific needs. Sessions will be conducted daily for 45 minutes, five days per week, over a two-month period.
Change in patients' physical function after the rehabilitation treatment as assessed by the Toronto Extremity Salvage Score (TESS) score
The Toronto Extremity Salvage Scores is the most commonly used, valid, and disease-specific measure to assess physical function in patients with bone and soft tissue tumors of the extremities undergoing limb salvage surgery. The Italian version will be used. The score ranges from 0 to 100, with 100 being the best score. According to tumor's location, either the upper or the lower limb section will be used. We will employ the Italian version of the TESS.
Toronto Extremity Salvage Score (TESS)
The Toronto Extremity Salvage Scores is the most commonly used, valid, and disease-specific measure to assess physical function in patients with bone and soft tissue tumors of the extremities undergoing limb salvage surgery. The Italian version will be used. The score ranges from 0 to 100, with 100 being the best score. According to tumor's location, either the upper or the lower limb section will be used. We will employ the Italian version of the TESS.
Musculoskeletal Tumor Society Rating Scale (MSTS)
The Musculoskeletal Tumor Society Rating Scale (MSTS) scoring system is a commonly used functional evaluation system for patients who undergo surgery for musculoskeletal tumors. The MSTS system consists of six key criteria, each graded on a five-point scale (0 to 5 points). The total score ranges from 0 to 30 points, where higher scores indicate better functional outcomes. According to tumor's location, either the upper or the lower limb section will be used.
Numerical Pain Rating Scale (NPRS)
The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale, from 0 (no pain) to 10 (worst pain imaginable).
Brief Pain Questionnaire (BPI)
The Brief Pain Inventory (BPI) is a rapid tool for assessing clinical pain. It consists of two sections. The first section, composed of four items, assesses pain intensity in different situations (current pain, worst pain, least pain, and average pain). The second section examines the impact of pain on daily life through seven items, covering work, recreational activities, mobility, sleep quality, mood, interpersonal relationships, and overall quality of life. Each item is rated using an 11-point Likert scale, ranging from 0 ("no pain/no interference") to 10 ("maximum pain/maximum interference").
Click on the lead sponsor to view all of their trials.
Fondazione Policlinico Universitario Campus Bio-Medico
Lead sponsor
Fondazione Don Carlo Gnocchi Onlus
Collaborator
Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale
Collaborator
