Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06873685

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

Led by Fondazione Policlinico Universitario Campus Bio-Medico · Updated on 2025-03-21

120

Participants Needed

3

Research Sites

34 weeks

Total Duration

On this page

Sponsors

F

Fondazione Policlinico Universitario Campus Bio-Medico

Lead Sponsor

F

Fondazione Don Carlo Gnocchi Onlus

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying patients with localized soft tissue sarcoma (STS), a rare group of tumors, to understand motor impairments after surgery and how personalized robotic rehabilitation might help. The study also examines the effects of surgery and related treatments on nutrition and quality of life. This non-profit, multicenter trial aims to identify motor deficits and assess recovery through detailed biomechanical assessments and patient questionnaires. Patients undergo surgery for STS and, if eligible, receive a personalized rehabilitation program focused on either the upper or lower limbs depending on tumor location. Rehabilitation combines conventional and robotic therapies, including robotic gait training and sensor-based movements for the upper limbs. Treatment sessions last 45 minutes daily, five days a week, for two months. Assessments occur at diagnosis, post-radiochemotherapy if given, one month after surgery, after rehabilitation, and up to eight months follow-up. Participants complete various evaluations including motor function tests with sensors, clinical scales for pain and disability, quality of life and nutrition questionnaires, and blood tests. Researchers track changes in physical function using the Toronto Extremity Salvage Score before and after rehabilitation. The study collects comprehensive data on patient health, tumor characteristics, and treatment outcomes over several months to better understand recovery and inform future care strategies.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient with primary and localized soft tissue sarcoma who is a candidate for limb-sparing surgery or retroperitoneal multivisceral resection with curative intent
  • Age 18 years or older
Not Eligible

You will not qualify if you...

  • Recurrent tumors
  • Metastatic disease
  • Candidate for palliative and non-radical surgery
  • Refusal to sign informed consent
  • Pregnant or breastfeeding women at the time of screening

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Pre-Surgical Assessment

Duration - Up to 1 week before surgery

Participants undergo comprehensive assessments including clinical, instrumental, quality of life, and nutritional evaluations to characterize motor performance and functional abilities before surgery and any preoperative therapies.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Surgery day and up to 1 month after surgery

Participants undergo surgical treatment for localized soft tissue sarcoma followed by initial recovery.

1 visit within one month after surgery for reassessment

Treatment

Duration - 2 months

Participants receive a personalized rehabilitation program incorporating conventional and robotic-based therapies tailored to the affected limb, conducted daily for 45 minutes, five days per week.

Daily sessions, five days per week, for 2 months; functional reassessment after rehabilitation

Follow-up

Duration - Up to 8 months after surgery

Participants attend follow-up assessments to evaluate long-term functional recovery, quality of life, and nutritional status up to eight months after surgery.

1 visit within eight months after surgery

Trial Site Locations

Total: 3 locations

1

Fondazione Policlinico Universitario Campus Bio-Medico

Rome, Lazio, Italy, 00128

Actively Recruiting

2

Fondazione Don Carlo Gnocchi ONLUS

Roma, RM, Italy, 00166

Active, Not Recruiting

3

Istituto Nazionale Tumori-IRCCS-Fondazione G.Pascale

Naples, Italy, 80131

Not Yet Recruiting

Loading map...

Research Team

B

Bruno Vincenzi

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Similar Trials

Colorectal Resections and Reconstructions in Patients With R...

Sarcoma, Soft Tissue

Actively Recruiting

13 locations

Deep Phenotyping Gait Deficits in Orthopedic Manifestations ...

Sarcoma, Bone

Actively Recruiting

1 location

Metformin Hydrochloride Combined With Standard Systemic Ther...

Sarcoma Metastatic

Actively Recruiting

2 locations

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Unraveling the Heterogeneity of Sarcoma Survivors' Health-Related Quality of Life Regarding Primary Sarcoma Location: Results from the SURVSARC Study.

Ilse van Eck, Dide den Hollander, Ingrid M E Desar...

https://pubmed.ncbi.nlm.nih.gov/33105807

Risk factors for postoperative wound complications after extremity soft tissue sarcoma resection: A systematic review and meta-analyses.

Jelena Slump, Esther Bastiaannet, Anastassi Halka...

https://pubmed.ncbi.nlm.nih.gov/31302071

Validation process of Toronto Exremity Salvage Score in Italian: A quality of life measure for patients with extremity bone and soft tissue tumors.

Laura Rossi, Michele Boffano, Alessandro Comandone...

https://pubmed.ncbi.nlm.nih.gov/31957034

Minimal clinically important differences in Toronto Extremity Salvage Score for patients with lower extremity sarcoma.

Koichi Ogura, Kosuke Uehara, Toru Akiyama...

https://pubmed.ncbi.nlm.nih.gov/31000377

A 14-item Mediterranean diet assessment tool and obesity indexes among high-risk subjects: the PREDIMED trial.

Miguel Angel Martínez-González, Ana García-Arellano, Estefanía Toledo...

https://pubmed.ncbi.nlm.nih.gov/22905215