This is a non-profit, multicenter, non-controlled interventional study aimed at
evaluating the main characteristics of motor disability and the impact of personalized
robotic rehabilitation in patients undergoing surgical treatment for localized soft
tissue sarcoma (STS).
Aim 1: Identify the clinical characteristics and motor deficits following surgical
intervention for soft tissue sarcoma (STS).
Aim 2: Evaluate the impact of a personalized robotic rehabilitation treatment on motor
recovery in patients with STS.
Aim 3: Assess the impact of perioperative treatments and surgery on quality of life and
nutritional status in patients with STS.
The primary endpoint of the study is the assessment of functional deficits and motor
quality in patients with STS who have undergone surgical treatment, both after surgery
and after a personalized rehabilitation program. The evaluation of functional deficits
will include the analysis of functional impairment, activity limitations, and pain, which
will be assessed using validated clinical scales. Motor quality will be measured using
MIMU and EMG sensors and motor tests to study muscle activity.
The secondary endpoints will include:
a comprehensive patient and disease assessment, recording: demographic information
and patient characteristics; past medical history; tumor location; histopathological
tumor characteristics; details on neoadjuvant therapies and surgical procedures.
the Quality of life assessment of the patients;
the nutritional status assessment of the patients.
Study Procedures and Interventions:
Comprehensive assessments-including general, clinical, instrumental, quality of life, and
nutritional evaluations-will be conducted at:
T0 (at diagnosis) to establish aims to characterize the impact of the tumor on the
patient's functional abilities.
T0+ (after radio-chemotherapy, if applicable) to assess the potential effects of
radio-chemotherapy before surgery.
Patients eligible for rehabilitation treatment will follow a structured evaluation
process:
T1 (within one month after surgery): reassessment to determine the functional impact of
surgery.
Rehabilitation phase: Patients will undergo conventional and robotic rehabilitation
therapies tailored to the upper or lower limbs.
T2 (after two months of rehabilitation): reassessment to measure functional recovery and
rehabilitation outcomes.
T3 (within eight-months from surgery): follow-up.
The sample size was calculated based on a change after the rehabilitation program at
least equal to the MCID of the scale. Specifically, 67 individuals are necessary
considering a 2-sided, paired t-test, an MCID of 7 points, a common standard deviation of
20 points, a correlation coefficient between paired samples of 0.5, a significance
threshold of 0.05, and a power of 0.80. This sample size will be increased to 90
individuals to account for a 25% loss at T2 owing to patients who will be unable to begin
the rehabilitation intervention or who will develop clinical complications during the
rehabilitation intervention. The power calculation was limited to patients with RPS and
lower limb ESTS since the MCID of the TESS for the upper limb module has not been
published. Moreover, we will enroll 30 patients with upper limb ESTS, based on number of
patients referred and operated at our units (UO1 and UO3) in the last 2 years. Findings
achieved in these patients will be considered exploratory for the scanty information
currently available in the literature.
All participating centers will follow a standardized operating procedure regarding
treatment and outcome assessment to ensure consistency across all sites. Data will be
systematically collected using the REDCap (Research Electronic Data Capture) platform.