NCT06873685Recruiting
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)
Source: ClinicalTrials.gov · Last updated 21 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 10 Feb 2025
- Start date
- 13 Mar 2025
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Fondazione Policlinico Universitario Campus Bio-Medico
- Diseases
- Sarcoma
- NCT number
- NCT06873685
What you commit to
- Study type: Interventional
- Planned participants: 120
- From 13 Mar 2025 to the primary completion date, 31 Dec 2025
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- candidate for palliative and non-radical surgery;
Other illness
- metastatic disease;
Other
- recurrent tumors;
- refusal to sign informed consent;
- Pregnant or breastfeeding women at the time of screening.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale" Coordinator of this site? Confirm its status | Naples | Italy | Not yet recruiting |
| Fondazione Don Carlo Gnocchi ONLUS Coordinator of this site? Confirm its status | Roma | Italy | Active, not recruiting |
| Fondazione Policlinico Universitario Campus Bio-Medico Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.