RecruitingNot ApplicableNCT06873685

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

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


Sponsor

Fondazione Policlinico Universitario Campus Bio-Medico

Enrollment

120 participants

Start Date

Mar 13, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is examining how soft tissue sarcoma (a cancer of muscle, fat, or connective tissue) and its treatment affect patients' movement, muscle strength, nutrition, and quality of life — and whether a robotic rehabilitation program can help patients recover function after major surgery. **You may be eligible if...** - You are 18 years old or older - You have been diagnosed with a primary (first-time), localized (non-spread) soft tissue sarcoma - You are scheduled for surgery to spare your limb or for removal of tumors in the abdomen/pelvis, with the goal of curing the cancer **You may NOT be eligible if...** - Your sarcoma has returned (recurrent tumor) - Your cancer has spread to other parts of the body (metastatic) - Your surgery is palliative (intended to relieve symptoms rather than cure) - You are pregnant or breastfeeding - You refuse to sign the informed consent form Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERRehabilitation

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.


Locations(3)

Fondazione Policlinico Universitario Campus Bio-Medico

Rome, Lazio, Italy

Fondazione Don Carlo Gnocchi ONLUS

Roma, RM, Italy

Istituto Nazionale Tumori-IRCCS-Fondazione G.Pascale

Naples, Italy

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NCT06873685


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