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

NCT06873685 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-03-21

No results posted yet for this study

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.

Conditions

  • Sarcoma, Soft Tissue

Interventions

OTHER

Rehabilitation

After 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.

Sponsors & Collaborators

  • Fondazione Don Carlo Gnocchi Onlus

    collaborator OTHER

  • Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale

    collaborator NETWORK

  • Fondazione Policlinico Universitario Campus Bio-Medico

    lead OTHER

Principal Investigators

  • Bruno Vincenzi, MD, PhD · Fondazione Policlinico Universitario Campus Bio-Medico

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-13
Primary Completion
2025-12-31
Completion
2026-08-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06873685 on ClinicalTrials.gov