Stroke Rehabilitation With Exoskeleton-assisted Gait: Clinical and Neuromuscular Outcomes.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 162
- 试验地点
- 5
- 主要终点
- Change in 6 Minute Walk Test (6MWT)
研究概览
简要总结
Gait recovery is one of the main goals of post-stroke rehabilitation where robotic-assisted practice has shown positive outcomes. However, literature lacks of clinical studies on exoskeleton-supported gait rehabilitation. Recently, a wearable exoskeleton (Ekso™, EksoBionics, USA) has been commercialized for re-enabling patients to stand and walk, involving them directly in steps trigger through body weight balance. The main aim of this study is to assess the clinical and neuromuscular effects of exoskeleton-based gait rehabilitation in sub-acute and chronic stroke patients, compared to patients with similar characteristics who will conduct a traditional over-ground gait training.
In this multicentric RCT, 162 stroke patients will be enrolled and randomly assigned to the Experimental Group (EG) or to the Control Group (CG). Patients will conduct at least 12 one-hour-sessions (about 3 times/ week) of Ekso™ (EG) or traditional over-ground (CG) gait rehabilitation. Clinical evaluations (lower limb Modified Ashworth Scale- MAS; Motricity Index - MI; Trunk Control Test - TCT; Functional Ambulation Classification - FAC; 10-meter walking test - 10mwt; 6-minute walking test - 6mwt; Walking Handicap Scale - WHS; Time Up and Go - TUG) will be administered to patients at the beginning (T1) and at the end (T2) of the training period. The primary outcome is the distance performed during the 6mwt. A follow up study at 1 month (T3) and at 3 months (T4) after T2 will be conducted.
详细描述
*Procedures During Screening Process:
This multicentric study will involve recruitment of individuals who have experienced a middle to severe stroke as well as patients with similar neurological weakness from the inpatient setting, outpatient clinics, as well as day rehabilitation sites through all the health institutes participating to this study project. Members of the research teams will perform the initial screening of potential subjects. These clinicians will determine study eligibility based on the inclusion and exclusion criteria provided by Ekso Bionics in accordance with the medical recommendations of Prof. Marco Franceschini.
Potential subjects will be asked questions regarding their medical history and current level of function. If the subject meets the criteria, researchers will then provide the subject with a consent form. The researchers will discuss the objectives, the study protocol, and the risks and benefits to each subject. The subjects will be given time to review the form and ask any questions about it.
Once each subject has provided informed consent, he or she will undergo a screening process to assess the joint range of motion, and any spasticity present (via Modified Ashworth Scale). These measures will be used to determine subject qualification based on inclusion and exclusion criteria. Vital signs (including heart rate, blood pressure and oxygen saturation) will be assessed at baseline, after each session, and during sessions as needed based on subject's signs and symptoms. Oxygen saturation and heart rate will be monitored using a pulse oximeter. Blood pressure will be assessed with a manual blood pressure cuff and stethoscope.
Participants will be screened at the first therapy session (T1) and at the last one (T2). Follow-up assessments will also take place at 1 month (T3) and 3 months (T4) after the end of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (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
- •stroke or similar neurological pathologies:
- •2 weeks up to 6 months after the acute event (subacute patients);
- •6 months or more after the acute event (chronic patients)
- •age between 18-80 years;
- •ability to fit into the device and joint motion which allows gait with it;
- •ability to tolerate upright standing for 30 seconds even with upper limbs support;
- •sufficient upper extremity strength and balance which allow gait with device;
- •ability and willing to give written consent and comply with the study procedures, including the follow-up visits.
排除标准
- •subject's height shorter than 150 cm or taller than 190 cm;
- •subject's weight greater than 100 kg;
- •contractures of the hip, knee, or ankle joints that might limit normal Range of Motion during gait;
- •medical issue that precludes full weight bearing and ambulation (e.g. orthopedic injuries, pain, severe osteoporosis, or severe spasticity)
- •history of significant problems with skin breakdown or current skin breakdown that would prevent subject from wearing the device;
- •cognitive and/or communicative disability (e.g. due to brain injury): patients must be able to follow directions and demonstrate learning skills;
- •pregnancy ;
- •untreated Deep Vein Thrombosis (DVT).
结局指标
主要结局
Change in 6 Minute Walk Test (6MWT)
时间窗: Session 1 (baseline), Session 12 (week 4), 1 month follow-up (week 8), and 4 month follow-up (week 20)
The 6MWT measures the distance a subject covers during an indoor gait on a flat, hard surface in 6 minutes, using assistive devices, as necessary. The test is a reliable and valid evaluation of functional exercise capacity and is used as a sub-maximal test of aerobic capacity and endurance. The minimal detectable change in distance for people with sub-acute stroke is 60.98 meters. The 6MWT is a patient self-paced walk test and assesses the level of functional capacity. Patients are allowed to stop and rest during the test. However, the timer does not stop. If the patient is unable to complete the test, the time is stopped at that moment. The missing time and the reason of the stop are recorded. This test will be administered while wearing a pulse oximeter to monitor heart rate and oxygen saturation, also integrated with Borg scale to assess dyspnea.
次要结局
- Change in Functional Ambulation Classification (FAC)(Session 1 (baseline), Session 12 (week 4), 1 month follow-up (week 8), and 4 month follow-up (week 20))
- Change in Trunk Control Test (TCT)(Session 1 (baseline), Session 12 (week 4), 1 month follow-up (week 8), and 4 month follow-up (week 20))
- Change in Barthel Index (BI(Session 1 (baseline), Session 12 (week 4), 1 month follow-up (week 8), and 4 month follow-up (week 20))
- Change in 10 Meter Walk Test (10MWT)(Session 1 (baseline), Session 12 (week 4), 1 month follow-up (week 8), and 4 month follow-up (week 20))
- Change in Modified Ashworth Scale (MAS)(Session 1 (baseline), Session 12 (week 4), 1 month follow-up (week 8), and 4 month follow-up (week 20))
- Change in Time Up And Go (TUG)(Session 1 (baseline), Session 12 (week 4), 1 month follow-up (week 8), and 4 month follow-up (week 20))
- Change in Motricity Index (MI)(Session 1 (baseline), Session 12 (week 4), 1 month follow-up (week 8), and 4 month follow-up (week 20))
- Change in Handicap Walking Scale (WHS)(Session 1 (baseline), Session 12 (week 4), 1 month follow-up (week 8), and 4 month follow-up (week 20))