Soft Tissue Sarcoma: Instrumented Evaluation of Motor Performance and Impact of Robotic Rehabilitation, Nutrition and Quality of Life Assessment (START-RUN1)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 6
- 主要终点
- Change in patients' physical function after the rehabilitation treatment as assessed by the Toronto Extremity Salvage Score (TESS) score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change in patients' physical function after the rehabilitation treatment as assessed by the Toronto Extremity Salvage Score (TESS) score
时间窗: T1 (1 months after surgery); T2 (after 2 months of rehabilitation treatment)
The Toronto Extremity Salvage Scores is the most commonly used, valid, and disease-specific measure to assess physical function in patients with bone and soft tissue tumors of the extremities undergoing limb salvage surgery. The Italian version will be used. The score ranges from 0 to 100, with 100 being the best score. According to tumor's location, either the upper or the lower limb section will be used. We will employ the Italian version of the TESS.
次要结局
- Toronto Extremity Salvage Score (TESS)(T0 (1 week before surgery); T0+ (after after radiochemotherapy, if administered before surgery); T1 (1 months after surgery); T2 (after 2 months of rehabilitation treatment); T3 (follow up, within 8 months after surgery))
- Musculoskeletal Tumor Society Rating Scale (MSTS)(T0 (1 week before surgery); T0+ (after after radiochemotherapy, if administered before surgery); T1 (1 months after surgery); T2 (after 2 months of rehabilitation treatment); T3 (follow up, within 8 months after surgery))
- Numerical Pain Rating Scale (NPRS)(T0 (1 week before surgery); T0+ (after after radiochemotherapy, if administered before surgery);T1 (1 months after surgery);T2 (after 2 months of rehabilitation treatment); T3 (follow up, within 8 months after surgery).)
- Brief Pain Questionnaire (BPI)(T0 (1 week before surgery); T0+ (after after radiochemotherapy, if administered before surgery);T1 (1 months after surgery);T2 (after 2 months of rehabilitation treatment); T3 (follow up, within 8 months after surgery))
- Douleur Neuropathique en 4 Questions (DN4)(T0 (1 week before surgery); T0+ (after after radiochemotherapy, if administered before surgery);T1 (1 months after surgery);T2 (after 2 months of rehabilitation treatment); T3 (follow up, within 8 months after surgery).)
- Leeds Assessment of Neuropathic Symptoms and Signs Scale (LANSS)(T0 (1 week before surgery); T0+ (after after radiochemotherapy, if administered before surgery);T1 (1 months after surgery);T2 (after 2 months of rehabilitation treatment); T3 (follow up, within 8 months after surgery).)
- Kinematic assessment of motor performance(T0 (1 week before surgery); T0+ (after after radiochemotherapy, if administered before surgery);T1 (1 months after surgery);T2 (after 2 months of rehabilitation treatment); T3 (follow up, within 8 months after surgery).)
- Surface electromyography (sEMG) assessment(T0 (1 week before surgery); T0+ (after after radiochemotherapy, if administered before surgery);T1 (1 months after surgery);T2 (after 2 months of rehabilitation treatment); T3 (follow up, within 8 months after surgery).)
- Quality-of-Life Questionnaire (QLQ)-C30(T0 (1 week before surgery); T0+ (after after radiochemotherapy, if administered before surgery);T1 (1 months after surgery);T2 (after 2 months of rehabilitation treatment); T3 (follow up, within 8 months after surgery).)
- Short Form Health Survey 36 (SF-36) - Mental Composite Score (MCS)(T0 (1 week before surgery), T0+ (after after radiochemotherapy, if administered before surgery), T1 (1 months after surgery) and T2 (after 2 months of rehabilitation treatment), T3 (follow up, within 8 months after surgery))
- Short Form Health Survey 36 (SF-36) - Physical Composite Score (PCS)(T0 (1 week before surgery), T0+ (after after radiochemotherapy, if administered before surgery), T1 (1 months after surgery) and T2 (after 2 months of rehabilitation treatment), T3 (follow up, within 8 months after surgery))
- PREDIMED questionnaire(T0 (1 week before surgery))
- Food diary compilation(T0 (1 week before surgery); T0+ (after after radiochemotherapy, if administered before surgery); T1 (1 months after surgery); T2 (after 2 months of rehabilitation treatment); T3 (follow up, within 8 months after surgery))
- Weight in kilograms(T0 (1 week before surgery), T0+ (after after radiochemotherapy, if administered before surgery), T1 (1 months after surgery) and T2 (after 2 months of rehabilitation treatment), T3 (follow up, within 8 months after surgery))
- Height in meters(T0 (1 week before surgery); T0+ (after after radiochemotherapy, if administered before surgery); T1 (1 months after surgery); T2 (after 2 months of rehabilitation treatment); T3 (follow up, within 8 months after surgery))
- Body mass Index in kg/(m^2)(T0 (1 week before surgery); T0+ (after after radiochemotherapy, if administered before surgery); T1 (1 months after surgery); T2 (after 2 months of rehabilitation treatment); T3 (follow up, within 8 months after surgery))
- Arm circumferences expressed in cm(T0 (1 week before surgery); T0+ (after after radiochemotherapy, if administered before surgery); T1 (1 months after surgery); T2 (after 2 months of rehabilitation treatment); T3 (follow up, within 8 months after surgery))
- Waist circumferences expressed in cm(T0 (1 week before surgery); T0+ (after after radiochemotherapy, if administered before surgery); T1 (1 months after surgery); T2 (after 2 months of rehabilitation treatment); T3 (follow up, within 8 months after surgery))
- Hips circumferences expressed in cm(T0 (1 week before surgery); T0+ (after after radiochemotherapy, if administered before surgery); T1 (1 months after surgery); T2 (after 2 months of rehabilitation treatment); T3 (follow up, within 8 months after surgery))
- Bioimpedance analysis (BIA) measurements(T0 (1 week before surgery); T0+ (after after radiochemotherapy, if administered before surgery); T1 (1 months after surgery); T2 (after 2 months of rehabilitation treatment); T3 (follow up, within 8 months after surgery))
- Concentration of blood levels of haemoglobin in g/dL(T0 (1 week before surgery); T0+ (after after radiochemotherapy, if administered before surgery); T1 (1 months after surgery); T2 (after 2 months of rehabilitation treatment); T3 (follow up, within 8 months after surgery))
- Concentration of blood levels of lymphocite expressed in count of cells or percentage(T0 (1 week before surgery); T0+ (after after radiochemotherapy, if administered before surgery); T1 (1 months after surgery); T2 (after 2 months of rehabilitation treatment); T3 (follow up, within 8 months after surgery))
- Concentration of albumine serum levels in g/dL(T0 (1 week before surgery); T0+ (after after radiochemotherapy, if administered before surgery); T1 (1 months after surgery); T2 (after 2 months of rehabilitation treatment); T3 (follow up, within 8 months after surgery))
- Concentration of total cholesterol serum levels in mg/dL(T0 (1 week before surgery); T0+ (after after radiochemotherapy, if administered before surgery); T1 (1 months after surgery); T2 (after 2 months of rehabilitation treatment); T3 (follow up, within 8 months after surgery))
- Concentration of serum C-reactive protein (CRP)(T0 (1 week before surgery); T0+ (after after radiochemotherapy, if administered before surgery); T1 (1 months after surgery); T2 (after 2 months of rehabilitation treatment); T3 (follow up, within 8 months after surgery))
- Concentration of glucose serum levels in mg/dL(T0 (1 week before surgery); T0+ (after after radiochemotherapy, if administered before surgery); T1 (1 months after surgery); T2 (after 2 months of rehabilitation treatment); T3 (follow up, within 8 months after surgery))
- Controlling Nutritional Status (CONUT)(T0 (1 week before surgery); T0+ (after after radiochemotherapy, if administered before surgery); T1 (1 months after surgery); T2 (after 2 months of rehabilitation treatment); T3 (follow up, within 8 months after surgery))
- Nutritional Risk Index score (NRI)(T0 (1 week before surgery); T0+ (after after radiochemotherapy, if administered before surgery); T1 (1 months after surgery); T2 (after 2 months of rehabilitation treatment); T3 (follow up, within 8 months after surgery))