Post-stroke Gait Rehabilitation With a Unilateral Hip Exoskeleton: Clinical and Neuromuscular Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Number of device-related adverse events
研究概览
简要总结
The goal of this clinical trial is to evaluate the safety, reliability, and short-term effectiveness of SHAJA-based training in improving walking velocity and endurance in post-stroke patients.
The main questions it aims to answer are:
- Does the SHAJA-based training improve walking velocity and endurance in post-stroke patients compared to conventional gait training?
- Is the SHAJA exoskeleton safe and reliable?
Researchers will compare the SHAJA-based training to a conventional gait training to see if the former works to improve walking ability.
Participants will:
- Perform six SHAJA-assisted gait training sessions or six conventional gait training sessions
- Perform five assessment sessions
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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
- •cerebral stroke, at least 3 months from cerebral event
- •ability to ambulate with no more than minimal contact assistance, even with aids (Functional Ambulation Classification, FAC >= 43)
- •self-selected walking velocity in the range [0.3-0.85] m/s
- •anthropometry consistent with the specifications of the tested devices
- •gait impairments that may benefit from hip assistance, e.g. hip weakness in flexion and/or extension (Medical Research Council, MRC, Scale for Muscle Strength >2 and <5 for flexion and extension)
排除标准
- •Modified Ashworth Scale >3 at the hip and/or ankle joints
- •Poor cognitive skills (corrected Mini-Mental State Examination, MMSE < 21)
- •inability to follow verbal 3 step commands
- •severe aphasia causing inability to communicate with the investigators
- •serious medical conditions (recent myocardial infarction in less than 3 months, uncontrolled congestive heart failure (CHF), uncontrolled hypertension, uncontrolled seizures)
- •leg deep vein thrombosis less than 6 weeks ago
- •other pre-existing neurological disorders (Parkinson's disease, Amyotrophic Lateral Sclerosis, Multiple Sclerosis, Dementia)
- •severe anxiety or depression (State-Trait Anxiety Inventory-Y, STAI-Y > 44, and the Beck Depression Inventory-II, BDI-II > 19)
- •severe osteoporosis
- •severe hip / knee osteoarthritis with limitation of movement or significant pain
- •use of a colostomy bag
- •skin wounds, infection, or problems at device contact locations
- •major orthopaedic surgery or fractures within the last 90 days (hip, knee, ankle, foot, spine)
- •cardiac surgery within the last 3 months
- •patient has recently or is currently participating in research that may influence, in PI's opinion, responses to study intervention
- •pregnancy
- •implanted cardiac devices, such as pacemakers or automatic defibrillators (AICD)
- •use of assistive device that, in the PI's opinion, could interfere with SHAJA
研究组 & 干预措施
SHAJA first, then conventional
Patients will perform the SHAJA-assisted gait training during the first period of the trial followed by a conventional gait training during the second period of the trial
干预措施: Unilateral hip exoskeleton (Device)
SHAJA first, then conventional
Patients will perform the SHAJA-assisted gait training during the first period of the trial followed by a conventional gait training during the second period of the trial
干预措施: Conventional gait training (Behavioral)
Conventional first, then SHAJA
Patients will perform the conventional gait training during the first period of the trial followed by a SHAJA-assisted gait training during the second period of the trial
干预措施: Unilateral hip exoskeleton (Device)
Conventional first, then SHAJA
Patients will perform the conventional gait training during the first period of the trial followed by a SHAJA-assisted gait training during the second period of the trial
干预措施: Conventional gait training (Behavioral)
结局指标
主要结局
Number of device-related adverse events
时间窗: From the pre-training evaluation (T1) to the second post-training evaluation, about 3 months after T1
Documenting device hardware and software malfunctions
时间窗: From the pre-training evaluation (T1) to the second post-training evaluation, about 3 months after T1
Changes in self-selected walking velocity (m/s) pre vs post Conventional training and SHAJA-assisted training interventions assessed with the 10 Metre Walk Test
时间窗: From the pre-training evaluation (T1) to the follow up, about 14 weeks after T1
Changes in fast walking velocity (m/s) pre vs post Conventional training and SHAJA-assisted training interventions assessed with the 10 Metre Walk Test
时间窗: From the pre-training evaluation (T1) to the follow up, about 14 weeks after T1
Changes in the difference between self-selected and fast walking velocity (delta m/s) pre vs post Conventional training and SHAJA-assisted training interventions assessed with the 10 Metre Walk Test
时间窗: From the pre-training evaluation (T1) to the follow up, about 14 weeks after T1
Changes in walking endurance (in minutes) pre vs post Conventional training and SHAJA-assisted training interventions assessed with a Walk Test
时间窗: From the pre-training evaluation (T1) to the follow up, about 14 weeks after T1
次要结局
- Changes in gait kinematics/kinetics pre vs post Conventional training and SHAJA-assisted training interventions assessed with a motion capture system(From the pre-training evaluation (T1) to the follow up, about 14 weeks after T1)
- Changes in the execution time of the Timed-Up-and-Go (TUG) test pre vs post Conventional training and SHAJA-assisted training interventions(From the pre-training evaluation (T1) to the follow up, about 14 weeks after T1)
- Changes in Berg Balance Scale pre vs post Conventional training and SHAJA-assisted training interventions(From the pre-training evaluation (T1) to the follow up, about 14 weeks after T1)
- Changes in Motricity Index for Lower Limb pre vs post Conventional training and SHAJA-assisted training interventions(From the pre-training evaluation (T1) to the follow up, about 14 weeks after T1)
- Changes in Modified Ashworth Scale (MAS) pre vs post Conventional training and SHAJA-assisted training interventions(From the pre-training evaluation (T1) to the follow up, about 14 weeks after T1)
- Changes in Functional Ambulation Classification (FAC) pre vs post Conventional training and SHAJA-assisted training interventions(From the pre-training evaluation (T1) to the follow up, about 14 weeks after T1)
研究者
Carmelo Chisari
Associate Professor
University of Pisa