The Potential of Robotic-Assisted Gait Training in a Rehabilitation Settin
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Spatio Temporal Gait Parameter (STGP)
研究概览
简要总结
Robotic-assisted gait training (RAGT) devices, such as the Lokomat®, are commonly used to support gait rehabilitation by enabling repetitive, task-specific walking movements. The functional proprioceptive stimulation (FPS) device Vibramoov® represents a novel technology designed to stimulate proprioceptors at the muscle-tendon junction through targeted vibratory stimuli, thereby activating sensorimotor centers in the brain and potentially facilitating movement execution.
The aim of this randomized controlled trial is to investigate whether Lokomat® training combined with Vibramoov® leads to greater improvements in qualitative and quantitative gait parameters in stroke patients compared with Lokomat® training alone. The study will be conducted at the Gröbming Rehabilitation Center and will include patients undergoing a four-week neurological inpatient rehabilitation program. Participants will be randomly assigned to an intervention group (Lokomat® + Vibramoov®) or a control group (Lokomat® only), with 20 patients per group.
Primary outcomes include the 6-Minute Walk Test (6MWT) and spatiotemporal gait parameters. Additional assessments include functional scores, patient-reported outcome measures, and blood biomarkers. Statistical analyses will be performed depending on data distribution. A follow-up assessment evaluating EQ-5D and PHQ-4 will be conducted six months after completion of the rehabilitation program.
详细描述
Stroke is the most common cause of physical disability in Western industrialized countries, with approximately 70% of patients experiencing moderate to severe physical impairments [1]. In addition to the negative impact on mobility and balance, activities of daily living are often affected [2]. In particular, gait impairments-manifested, for example, by reduced walking speed or shortened step length-can significantly reduce the quality of life of patients after stroke [2,3]. Therefore, the restoration of a physiological gait pattern in terms of both qualitative and quantitative parameters represents a key objective of post-stroke rehabilitation.
In addition to conventional therapeutic approaches, robotic-assisted gait training (RAGT) devices such as the Lokomat® are frequently used [4]. With this device, patients are able to walk actively on a treadmill while being supported by an exoskeleton that simulates a symmetrical, bilateral gait pattern [3]. RAGT devices aim to improve walking by enabling a high number of repetitions of task-oriented movements, thereby facilitating the relearning of movement patterns [5].
Novel technologies such as the functional proprioceptive stimulation (FPS) device Vibramoov® may have the potential to enhance the effectiveness of RAGT. This therapeutic device aims to stimulate proprioceptors located at the muscle-tendon junction through targeted vibratory stimuli, thereby activating sensorimotor centers in the brain via afferent Ia fibers [6]. As a result, the execution of movements-for example during walking-may be facilitated. According to the manufacturer, Vibramoov® can be used during walking on level ground, during treadmill walking, or in combination with the Lokomat®. However, to date there is no research investigating the effects of Vibramoov® on gait parameters in stroke patients undergoing inpatient rehabilitation.
The aim of the present study is therefore to contribute to the investigation of FPS as a potential approach to maximize the effectiveness of RAGT. The primary research question is: Does Lokomat® training combined with the Vibramoov® device have a greater effect on qualitative and quantitative gait parameters in patients after stroke compared with Lokomat® training alone? To address this research question, a randomized controlled trial will be conducted at the Gröbming Rehabilitation Center. Patients after stroke who are undergoing a four-week neurological inpatient rehabilitation program will be randomly assigned to either an intervention group or a control group. Based on data regarding the effect of RAGT on the 6-Minute Walk Test (6MWT), and accounting for potential dropouts, a sample size of 20 patients per group was calculated [4].
Patients in both groups will receive the conventional rehabilitation program according to the medical service profile, in which RAGT represents part of the standard treatment for stroke patients with gait impairments. Patients in the control group will perform RAGT using the Lokomat®, while patients in the intervention group will perform RAGT using the Lokomat® in combination with Vibramoov®. The extent of RAGT will be identical in both groups.
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
- 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
- •Diagnosis of stroke (ischemic or hemorrhagic) ≥ 3 months
- •Age ≥ 18a and ≤ 80a
- •6MWT ≤ 200m
- •Barthel Index ≤ 95
- •Mini Mental State Exam (MMSE) ≥ 24
- •BBS): ≤49
- •Modified Ashworth Scale (MAS): 0-3 for the lower extremity
排除标准
- •The presence of any comorbidity or disability other than stroke that would preclude gait training
- •Any uncontrolled health condition for which exercise is contraindicated
研究组 & 干预措施
Lokomat + Vibramoov
Patients in the interventional group receive RAGT (Lokomat) combined with vibrational stimuli (Vibramoov). Additionally they receive the standard rehabiliation procedure.
干预措施: Lokomat + Vibramoov (Device)
Lokomat
Patients in the interventional group receive the conventional RAGT (Lokomat) without vibrational stimuli (Vibramoov). Additionally they receive the standard rehabiliation procedure.
干预措施: Lokomat (Device)
结局指标
主要结局
Spatio Temporal Gait Parameter (STGP)
时间窗: At baseline and 4 weeks later after intervention
STGP, such as cadence or step lenght measured in a clinical gait analysis by a pressure measuring plate.
6 Minute Walk Test (6MWT)
时间窗: At baseline and 4 weeks later after intervention
The 6MWT is a simple functional exercise test used to assess a person's walking capacity and endurance. It measures the distance a patient can walk in six minutes on a flat surface and reflects their submaximal level of functional capacity.
次要结局
- Brain Derived Neurotrophic Factor (BDNF)(At baseline and 4 weeks later after intervention)
- Routine Laboratory Parameter(At baseline and 4 weeks later after intervention)
- Berg Balance Scale(At baseline and 4 weeks later after intervention)
- Functional Ambulation Category (FAC)(At baseline and 4 weeks later after intervention)
- Patient Health Questionnaire-4 (PHQ-4)(At baseline and 4 weeks later after intervention)
- European Quality of Life 5 Dimensions (EQ-5D)(At baseline and 4 weeks later after intervention)