Adaptability Training for Individuals After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Walking Adaptability Ladder Test (WALT) score
研究概览
简要总结
Background: The majority of stroke survivors regain walking ability, however the ability to adapt their gait to meet environmental demands remains impaired. This impaired gait adaptability has a profound impact on activities of daily living and quality of life. Treatment targeting these gait deficiencies is, therefore, critical for allowing safe and independent community ambulation in people with stroke. Rehabilitation programs targeting gait adaptability have gained interest in clinical practice. Besides, the use of augmented and virtual reality in rehabilitation programs becomes more common. Concerning gait adaptability, training programs are developed using the Cmill, an instrumented treadmill with augmented reality. Even though the efficacy of these interventions is limited to small, pilot trials, results are promising. Based on these results we hypothesize that a gait training program using the Cmill will improve gait adaptability and daily-life gait performance in people in the chronic phase after stroke.
Objective: The primary objective of this study is to evaluate the efficacy of a gait training program using an instrumented treadmill with virtual and augmented reality for improving gait adaptability in people in the chronic phase after stroke. A second objective is to identify patient characteristics that predict a more favorable response to training.
Study design: Randomized, waiting-list controlled trial to evaluate gait adaptability training
Study population: 84 stroke patients in the chronic phase after 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
- Single (Outcomes Assessor)
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
- •> 6 months after first unilateral supratentorial stroke (chronic phase)
- •Able to walk at least 10 minutes independently
排除标准
- •Any other neurological or musculoskeletal disease affecting gait or balance (e.g. Parkinson's disease, knee osteoarthritis)
- •Contractures or spasticity requiring other treatment (e.g. botulinum toxin treatment) within the duration of the training period.
- •Has received multiple training sessions on C-Mill or GRAIL in the past 12 months
- •Severe cognitive or visuo-spatial impairments limiting comprehension of instructions or correct perception of the environments
结局指标
主要结局
Walking Adaptability Ladder Test (WALT) score
时间窗: Within 1 week post-intervention
Measure of gait adaptability. An adapted version for adults of the Walking Adaptability Laddertest for Kids (WAL-K) to assess the ability to flexibly adjust the gait pattern during overground walking. Outcome is based on performance time and foot placement errors measured in seconds where a lower score is a better outcome.
Emory Functional Ambulation Profile (EFAP) score
时间窗: Within 1 week post-intervention
Measure of gait adaptability. In this task the participants traverse a standardized 5m obstacle course. Outcome is time to perform the task measured in seconds where a lower score is a better outcome.
次要结局
- Balance performance(Within 1 week post-intervention)
- Balance confidence(Within 1 week post-intervention)
- Daily life gait performance as assessed by gait quality(Within 1 week post-intervention)
- Daily life walking activity assessed by walking time per day(Within 1 week post-intervention)
- Balance performance through MiniBESTest(Within 1 week post-intervention)
- Lab-based walking adaptability test(Within 1 week post-intervention)
- Walking performance(Within 1 week post-intervention)
- Health-related quality of life(Within 1 week post-intervention)