NCT06873685

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)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Fondazione Policlinico Universitario Campus Bio-Medico · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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: 1. 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. 2. the Quality of life assessment of the patients; 3. 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.

Conditions

• Sarcoma, Soft Tissue

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-03-13
• Primary completion: 2025-12-31
• Completion: 2026-08-31
• First posted: 2025-03-13
• Last updated: 2025-03-21

Locations

3 sites across 1 country: Italy