Real-time Auditory Feedback for Improving Gait and Walking in People With Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Reliable Change in Six-Minute Walk Test
研究概览
简要总结
Introduction: The purpose of this study is to test the efficacy potential of using real-time positive auditory feedback to improve gait pattern in people with Parkinson's Disease (PD). The components of walking are commonly affected in patients with PD. Gait training for PD is usually based on verbal cues from the therapist that are only moderately effective. Based on good principals of gait and neuroplasticity, the Heel-To-Toe (Heel2Toe) sensor was developed to provide real-time auditory feedback during walking training. Methods: A two-group, randomized feasibility trial is planned with repeated measures of gait parameters and walking outcomes. Participants will be assessed at baseline, 3 and 6 months. Outcomes after the 5 training days will be obtained directly from the Hee2Toe device for both groups (with and without auditory feedback). The primary outcome is walking capacity measured by the Six-Minute Walk Test and the Standardized Walking Obstacle Course. Gait parameters will be captured by the Heel2Toe device Expected Contributions: Gait training using the Heel2Toe sensor will be potentially effective for improving walking pattern in people with PD.
详细描述
As this is a feasibility study, the main analysis will focus on within-group change over the intervention period of 3 months using indices of reliable change(36). This method assesses the number of people who changed in each of the groups based on the magnitude of change relative to pre-post variability and correlation. We will estimate the proportion of people with reliable change. Estimates from the pilot study will be used to plan the main trial if the pilot demonstrates feasibility. For the maintenance period, reliable change from baseline will also be estimated and used to identify the proportion of people who maintained reliable change or who gained/lost this status.
The study is designed to detect a minimal important within-group change of moderate magnitude or greater (effect size ½ standard deviation) with adequate precision. A sample size of 20 in the intervention with completed follow-up will provide a 95% confidence interval with precision that excludes an effect size of 0.03.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
An evaluator who does not know to which group the participant was assigned will conduct the evaluations. The outcomes are tests of performance.
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
- •Diagnosis of Parkinson Disease and be independent in ambulation without use of walking aid
排除标准
- •exercising three or more time per week;
- •Had any additional illness that restricted their function
- •Showing difficulty reading, understanding or speaking either French or English
结局指标
主要结局
Reliable Change in Six-Minute Walk Test
时间窗: Baseline, 3 months (Change from Baseline to 3 months; maintenance to 6 months)
Performance-rated outcome
Change in Standardized Walking Obstacle Course (SWOC)
时间窗: Baseline, 3 months (Change from Baseline to 3 months; maintenance to 6 months)
Performance-rated outcome of challenges experienced with starting, stopping, turning, making motor decisions. The metric is the time to complete a 12.2-m long, 0.92-m wide curved pathway, with obstacles commonly encountered in daily life.
次要结局
- Change in Lower Extremity Function (Neuroqol)(Baseline, 3 months (Change from Baseline to 3 months; maintenance to 6 months))
- Change in motivation (Starkstein Apathy Scale, Activity Effort Inventory)(Baseline, 3 months (Change from Baseline to 3 months; maintenance to 6 months))
- Safety (Falls)(Baseline to 3 months.)
- Technology acceptability (System Usability Scale)(3 months (1 time point))
- Change in Postural Instability and Gait Dysfunction (UPDRS)(Baseline, 3 months (Change from Baseline to 3 months; maintenance to 6 months))
- Change in health states (Visual Analogue Health States)(Baseline, 3 months (Change from Baseline to 3 months; maintenance to 6 months))
- Change in Gait Quality (Data capture from Heel2Toe sensor)(Baseline, 3 months (Change from Baseline to 3 months; maintenance to 6 months)])
- Change in health-related quality of life (EQ-5D-3L)(Baseline, 3 months (Change from Baseline to 3 months; maintenance to 6 months))
- Cognitive performance (Symbol Digit Modality Test)(Baseline, 3 months, 6 months)