Clinical Protocol for a Pragmatic Trial on a High-Tech Rehabilitation Pathway for Acute Adult Neuromuscular Diseases (Fit4MedRob-Acute MND Project)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 124
- 试验地点
- 8
- 主要终点
- Change from baseline in Berg Balance Scale
研究概览
简要总结
The goal of this study is determine if a high-tech rehabilitation circuit is more effective than usual rehabilitation methods in improving functional outcome, particularly balance control, for patients with acute neuromuscolar diseases. The main question it aims to answer is:
Are high-tech rehabilitation interventions, including robotic systems, virtual reality, and stabilometric platforms, more effective than traditional rehabilitation methods in improving balance, motor function, fatigue levels, sarcopenia, cognitive engagement, and overall quality of life in patients with acute neuromuscular diseases (NMDs)? Researchers will compare a robotic treatment group, that consists in an high-tech rehabilitation, with a control group, that will receive the traditional rehabilitative treatment.
详细描述
Objective: To evaluate the efficacy of a novel rehabilitation protocol integrating advanced technologies in the treatment of acute neuromuscular diseases (NMDs).
Background: NMDs affect muscle function and are directly controlled by the nervous system. Traditional rehabilitation often falls short in addressing the multifaceted needs of NMD patients. This gap underscores the necessity for innovative rehabilitation approaches that can significantly enhance the quality of life and optimize recovery outcomes following acute events.
Methods: The protocol integrates advanced technologies to address the rehabilitation needs of patients with acute NMDs. It utilizes robotic systems to ensure consistent and precise movement, virtual reality for immersive and engaging therapy, and stabilometric platforms to enhance balance training. The focus is on acute NMDs such as Guillain-Barré Syndrome (GBS), Critical illness myopathy (CIM) and polyneuropathy (CIP), either individually or in combination (CIP/CIM). The approach emphasizes rapid rehabilitation to maximize recovery outcomes.
Study Design: An interventional, randomized, superiority case-control study with a parallel assignment. The trial aims to compare the efficacy of high-tech rehabilitation methods against conventional treatments in improving patient outcomes.
Outcome Measures: To assess the improvement at least 10 points in balance measured using the Berg Balance Scale (BBS) from baseline to the end of the treatment period comparing the high-tech rehabilitation circuit with standard rehabilitation protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults with ages ranging from 18 to 80 years.
- •Patients with a confirmed diagnosis of acute/subacute neuromuscular diseases (e.g. GBS, CIM, CIP)
- •Time of onset ranging from 15 to 30 days
- •Patients with lower limb strength (Medical Research Council or MRC) >=2 in at least two of the flexor and extensor muscles of the following joints: hip, knee and ankle
- •Possibility of obtaining informed consent
排除标准
- •Patients with unstable medical conditions (e.g. severe cardiovascular diseases, such as "New York Heart Association" - NYHA=4, respiratory distress not compensated by ventilation) that could interfere, in the clinician's judgment, with their ability to safely participate in the study or to perform the assessments related to the protocol.
- •Patients currently participating in other clinical trials that could interfere with this study.
- •Pregnant or breastfeeding women.
研究组 & 干预措施
Control group
The patients will receive the traditional rehabilitative treatment according to the good clinical practice according to the Diagnostic, Therapeutic and Care Pathways of each center involved
干预措施: Rehabilitation (Other)
Robotic treatment group
In this arm, patients will be divided into 3 treatment types based on their Berg Balance Scale (BBS) score at the time of randomization. Phase 1 (BBS <= 20) involves treatment with a robotic verticalization system (ERIGO) and action observation training with a virtual reality device.
Phase 2 (21 < BBS < 40) involves treatment with a robotic verticalization system (ERIGO), action observation training with a virtual reality device, and proprioceptive exercises on robotic platforms (e.g. GEA MASTER or PROKIN Technobody).
Phase 3 (BBS >= 41) involves motor and cognitive exercises using virtual reality device, proprioceptive exercises on robotic platforms (e.g. GEA MASTER or PROKIN Technobody), and aerobic exercises on a robotic treadmill (e.g. Walkerview Technobody).
干预措施: High-tech rehabilitative treatment (Device)
结局指标
主要结局
Change from baseline in Berg Balance Scale
时间窗: At the end of treatment at day 60
Improvement in balance measured by the Berg Balance Scale (BBS), with a target improvement of at least 10 points from baseline to the end of the treatment period. BBS is used to objectively determine a patient's ability (or inability) to safely balance during a series of 14 tasks; each task ranks from 0 to 4, with a total score of 56. Higher score indicates the higher level of function.
次要结局
- Change from baseline in Modified Barthel Index(At day 15, at day 30, at day 45, at day 60)
- Change from baseline in Trunk Control Test(At day 15, at day 30, at day 45, at day 60)
- Change from baseline in 2-Minute Walk Test(At day 15, at day 30, at day 45, at day 60)
- Change from baseline in Modified Erasmus GBS Outcome Score(At the end of treatment at day 60)
- Change from baseline in Handgrip strenght test(At day 15, at day 30, at day 45, at day 60)
- Change from baseline in Isometric muscles strenght(At day 15, at day 30, at day 45, at day 60)
- Change from baseline in Numeric Rating Scale(At day 30 and day 60)
- Change from baseline in 12-Short Form-12 Survey(At day 30 and day 60)
- Change from baseline in Technology Assisted Rehabilitation Patient Perception Questionnaire(At day 30, at day 60)