Visually-guided Gait Training in Paretic Patients During First Rehabilitation: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Change in walking speed
研究概览
简要总结
The GASPAR trial is a pragmatic, parallel-arms, single-center, non-blinded, superiority randomized control trial in neurorehabilitation. The main objective is to test whether a 4 weeks gait rehabilitation program that uses augmented reality is superior to a conventional treadmill training program of equivalent intensity. Baseline assessments precede allocation, which consists in blocking randomization (2:1 ratio) with stratification according to the disease etiology. Post-intervention assessments serve to compare the short-term efficacy of the intervention between the two groups. Three months after discharge, follow-up assessments take place to detect potential long-term effects.
详细描述
After a lesion to the central nervous system, many patients suffer from a diminished walking capability. During the first rehabilitation phase, specific cares help the recovery of motor function to offer the best chances of returning to normal walk. For example, the repeated practice of walking exercises facilitates the gain of muscular strength and stimulates motor relearning. However, in patients, who have finished the first rehabilitation phase, it is often observed strong limping, unsteady gait, and a bad management of obstacle clearance. Thus, these individuals fall frequently, with risk of severe injury. The aim of the study is to assess the efficacy of gait training on a treadmill equipped with an augmented reality system. Shapes are displayed onto the treadmill belt with a projector (beamer): the patient adapts his/her gait to the drawing that unfolds in front of him/her. It is possible to train gait symmetry for coordination enhancement or to exercise obstacle clearance and gait agility. Another advantage of this type of treadmill is the capability to continuously analyze gait with integrated sensors and, hence, to give real-time feedback to the patient. Whereas the method seems promising, thorough studies that would confirm its efficacy are lacking. Therefore, the investigators seek to conduct a randomized controlled trial to compare visually-guided gait training with a more classical training method. During four weeks, participants will train, according to their abilities, three to five times a week during 30 minutes on the augmented-reality treadmill. A group of control patients will train at comparable intensity but without the visual guidance of gait. Using the data collected during the training sessions, the investigators will study whether the evolution of locomotor function differs between both groups. Furthermore, several questionnaires will be filled in by the participants to document the self-evaluation of their progress. In the long term, the investigators expect to first improve the efficacy of gait rehabilitation and second to better understand the recovery process of locomotor function during the first months after a stroke.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants fulfilling all of the following inclusion criteria are eligible for the study:
- •Informed Consent as documented by signature
- •Stroke patients, patients with traumatic brain injury, or patients with spinal cord injury in the acute to sub-acute phase (maximum 40 days after the incident)
- •Need for gait rehabilitation in reason of at least one of the following conditions: Paresis of the lower extremities. Severe balance disorders. No walking at entry due to the neurological injury
- •Ability to walk 2 minutes without or with minimal aid, namely: With the help of one person, or: With walking aid (cane, walker)
- •The presence of any one of the following
排除标准
- •will lead to exclusion of the participant:
- •Age < 18 years
- •Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.) that may threaten the health in case of sustained exercise.
- •Concomitant gait disorders induced by acute to sub-acute musculoskeletal injuries, e.g. fracture of the lower extremities.
- •Severe pre-existent gait disorders that deeply affect walking abilities and gait pattern, either due to musculoskeletal (e.g. severe osteoarthritis) or neurological (e.g. Parkinson's disease) etiologies.
- •Severe non-corrected visual impairment
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.
研究组 & 干预措施
Augmented reality training
Gait training with augmented reality
干预措施: Gait training with augmented reality (Device)
Standard training
Gait training without augmented reality
干预措施: Standard training (Device)
结局指标
主要结局
Change in walking speed
时间窗: Pre-intervention (week 0), Post-intervention (week 5)
Walking speed, measured with the 2-minute walk test
次要结局
- Fear of falling at home(after discharge at 3-4 month)
- Perception of the intervention(During the intervention, week 2 and 4)
- Changes in stride and step durations(In every gait training sessions, from week 1 to week 4)
- Change in left/right asymmetry of step durations(In every gait training sessions, from week 1 to week 4)
- Quality of life at home(after discharge at 3-4 month)
- Change in step width(In every gait training sessions, from week 1 to week 4)
- Change in left/right asymmetry of step lengths(In every gait training sessions, from week 1 to week 4)
- Changes in stance and swing phases(In every gait training sessions, from week 1 to week 4)
- Change in gait variability(In every gait training sessions, from week 1 to week 4)
- Change in postural control(Pre-intervention (week 0), Post-intervention (week 5))
- Fear of falling during the hospitalization(week 5)
- Changes in stride and step lengths(In every gait training sessions, from week 1 to week 4)
研究者
Philippe Terrier
Senior Researcher
Clinique Romande de Readaptation