GaitBetter: Motor and Cognitive Training for Gait Rehabilitation and Falls Prevention in Stroke Survivors.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- 10 meter walk test (in chronic stroke survivors, Aim 2)
研究概览
简要总结
In this research study, the investigators aim to test the usability and efficacy of the GaitBetter system for gait rehabilitation after stroke.
详细描述
This study consists of 3 distinct aims:
In Aim 1, the investigators will evaluate clinical acceptance of the GaitBetter solution by subjects and therapists. To do so, the investigators will run a pilot study to gather feedback from stakeholders (not reported here).
In Aim 2, the investigators will evaluate the efficacy of using the GaitBetter solution to improve motor-cognitive function of chronic stroke survivors. To do so, the investigators will run a single-arm, non-randomized study to test the hypothesis that the GaitBetter training is effective in improving gait and cognition in individuals with chronic stroke.
In Aim 3, the investigators will explore the efficacy of using the GaitBetter solution for improving rehabilitation outcomes in sub-acute stroke survivors. To do so, the investigators will run a randomized, controlled study to evaluate the effects of using the GaitBetter system in patients with subacute stroke on recovery trajectory.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and females of age between 18 to 85 year of age
- •History of one-sided ischemic or hemorrhagic stroke
- •Chronic: more than 6 months post-stroke (Aim 1 and Aim 2)
- •Subacute: within 8 weeks post-stroke (Aim 1 and Aim 3)
- •Residual functional impairment of a lower extremity as a result of the stroke
- •Ability to walk at least 15 meters with or without assistive devices (FIM walk subsection, levels 6 and 7)
- •Ability to walk 3 consecutive minutes (5 minutes for Aim 2) on a treadmill at a speed equal to or greater than 0.22 m/s (0.8 km/h or 0.5 mph) with or without hand support.
- •Medical clearance received from treating physician to participate in the gait training program proposed in the study
排除标准
- •Severe aphasia limiting the ability to express needs or discomfort verbally or non-verbally
- •Cognitive impairment limiting the ability to understand and follow instructions (as assessed by a score <23 on the Mini Mental State Examination)
- •Previous diagnosis of neurological diseases other than stroke
- •Recent history of lower extremity fractures (<12 months ago), unhealed wounds
- •Current indication for isolation precautions (e.g. MRSA, VRE, C. difficile, and others)
- •Severe visual impairments (as assessed by the NIH Stroke Scale Visual Field subscale. score >0)
- •Hemispatial neglect (as assessed by the Line Bisection Test)
- •Subjects diagnosed with a medical condition that would interfere with their participation in regular sustained exercise (such as a severe pulmonary and/or cardiovascular condition)
- •For Aim 2: currently participating in a gait training intervention (PT or research)
- •Adults with impaired decision-making capacity
- •Women who are pregnant
研究组 & 干预措施
Aim 2: Efficacy of the GaitBetter to improve motor-cognitive function of chronic stroke survivors
The investigators propose a single-arm, non-randomized study to test the hypothesis that the GaitBetter training is effective in improving gait and cognition in individuals with chronic stroke. This design was chosen given the expected stability of functional recovery in this population.
干预措施: Treadmill gait training with GaitBetter (Device)
Aim 3: Efficacy of the GaitBetter to improve rehabilitation outcomes in sub-acute stroke survivors
The investigators propose a randomized, controlled study to evaluate the effects of using the GaitBetter system in patients with subacute stroke on recovery trajectory.
干预措施: Treadmill gait training with GaitBetter + Standard of care (Other)
Aim 3: Efficacy of the GaitBetter to improve rehabilitation outcomes in sub-acute stroke survivors
The investigators propose a randomized, controlled study to evaluate the effects of using the GaitBetter system in patients with subacute stroke on recovery trajectory.
干预措施: Standard of care (Other)
结局指标
主要结局
10 meter walk test (in chronic stroke survivors, Aim 2)
时间窗: Change from baseline scores at post-intervention (after 5 weeks)
Evaluation of gait speed of chronic stroke survivors, in meters per second
10 meter walk test (in subacute stroke survivors, Aim 3)
时间窗: Change from baseline scores at post-intervention (after 5 weeks)
Evaluation of gait speed of subacute stroke survivors, in meters per second
Trail making test (in chronic stroke survivors, Aim 2)
时间窗: Change from baseline scores at post-intervention (after 5 weeks)
Evaluation of cognition status, in chronic stroke survivors. The test record the time to accomplish the task (higher values indicate slower performance)
Trail making test (in subacute stroke survivors, Aim 3)
时间窗: Change from baseline scores at post-intervention (after 5 weeks)
Evaluation of cognition status, in subacute stroke survivors. The test record the time to accomplish the task (higher values indicate slower performance)
Balance Evaluation Systems Test (mini-BESTest, in chronic stroke survivors, Aim 2)
时间窗: Change from baseline scores at post-intervention (after 5 weeks)
Comprehensive evaluation of balance and falls risks in chronic stroke survivors. Score from 0 to 108. Higher scores are reflecting better balance
Aim 3: Balance Evaluation Systems Test (mini-BESTest, in subacute stroke survivors, Aim 3)
时间窗: Change from baseline scores at post-intervention (after 5 weeks)
Comprehensive evaluation of balance and falls risks in subacute stroke survivors. Score from 0 to108. Higher scores are reflecting better balance
次要结局
- Step length (in chronic stroke survivors, Aim 2)(Change from baseline scores at post-intervention (after 5 weeks))
- Step length (in subacute stroke survivors, Aim 3)(Change from baseline scores at post-intervention (after 5 weeks))
- Step width (in chronic stroke survivors, Aim 2)(Change from baseline scores at post-intervention (after 5 weeks))
- Step width (in subacute stroke survivors, Aim 3)(Change from baseline scores at post-intervention (after 5 weeks))
- Step symmetry (in chronic stroke survivors, Aim 2)(Change from baseline scores at post-intervention (after 5 weeks))
- Step symmetry (in subacute stroke survivors, Aim 3)(Change from baseline scores at post-intervention (after 5 weeks))
- Stance time (in chronic stroke survivors, Aim 2)(Change from baseline scores at post-intervention (after 5 weeks))
- Stance time (in subacute stroke survivors, Aim 3)(Change from baseline scores at post-intervention (after 5 weeks))
- Swing time (in chronic stroke survivors, Aim 2)(Change from baseline scores at post-intervention (after 5 weeks))
- Swing time (in subacute stroke survivors, Aim 3)(Change from baseline scores at post-intervention (after 5 weeks))
研究者
Paolo Bonato
Principal Investigator, Director of the Motion Analysis Laboratory
Spaulding Rehabilitation Hospital