Remotely Prescribed and Monitored Home-based Gait-and-balance Therapeutic Exergaming Using Augmented Reality (AR) Glasses: Protocol for a Clinical Feasibility Study in People With Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Mini Balance Evaluation Systems Test (Mini-BESTest) [Gait-and-balance outcome measures]
研究概览
简要总结
Despite optimal treatment with medication, people with Parkinson's disease (PD) still experience symptoms and secondary complications. Physiotherapy has long been recognized as one of the leading treatments in PD for slowing progression of the disease and retaining a higher quality of life for longer. Physiotherapy includes, among other things, training motor functions e.g., gait, balance and strength training and encourages physical activity. Exercise is an important part of healthy living for everyone, but for people with PD, exercise is medicine. Studies even suggest that exercise may slow down disease progression. Another way of improving PD motor symptoms, such as festination and freezing of gait (FOG), in a more direct way is by sensory cueing. Cueing is defined as the application of spatial or temporal external stimuli to help initiate, or facilitate gait, and can be presented as acoustic, visual, or tactile stimuli. It has been well known for many years that sensory cueing is effective and there has been extensive research on the topic.
Cue X is a new product developed by Strolll Limited (www.strolll.co) that applies the existing proven principles of exercise and sensory cueing for PD onto augmented-reality (AR) headsets implemented in two modules: movement training and movement assistance. The movement training module is designed to train gait and balance in a gamified manner to maximize training compliance. With this clinical feasibility study, the investigators want to examine the feasibility and potential efficacy of the Cue X movement training module to train gait and balance of people with PD in their home environment.
详细描述
The primary objective of this clinical feasibility study in people with PD is to evaluate the feasibility and potential efficacy of home-based gamified AR gait-and-balance exercises with Cue X. Secondary objectives of this study are to validate the gait-modifying effects of Cue X AR cueing and to quantify the test-retest reliability and concurrent validity of (clinical) outcome measures of gait and balance, as derived from AR headset data.
With these primary and secondary objectives, the study will give insight into 1) the feasibility and potential efficacy of Cue X for home-based gamified AR gait-and-balance exercises, 2) the most effective type of AR cueing and 3) the best parameters for feedback, reporting and sample-size calculations for a subsequent effect study with Cue X. Furthermore, the study will inform about the best AR headset for these purposes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Have command of the Dutch language
- •Diagnosed with PD according to the UK PD Brain Bank criteria (stages 2-4 on the Hoehn and Yahr scale)
- •Bothersome gait or balance impairments (i.e., negatively affecting their ability to perform their usual daily activities)
排除标准
- •Inability to comply with the protocol, i.e. additional neurological diseases and/or orthopaedic problems seriously interfering with gait function, insufficient physical capacity or cognitive/communicative inability (as observed by the researcher or clinician) to understand instructions and participate in the tests
- •Visual or hearing impairments (after corrective aids)
- •Severe visual hallucinations or illusions
- •Inability to walk independently for 30 minutes
- •No stable dosage of medication
结局指标
主要结局
Mini Balance Evaluation Systems Test (Mini-BESTest) [Gait-and-balance outcome measures]
时间窗: Change between pre-, mid- and post-training measure (over a period of 12 weeks, which includes 6 weeks waiting list and 6-week intervention)
To measure balance and postural control. Minimum - maximum score: 0 - 28. Higher scores indicate better balance and postural control.
Number of adverse events [safety]
时间窗: During 6-week training
To measure safety of the Cue X training module
Patient-reported outcome measures (PROMs)
时间窗: Change between pre-, mid- and post-training measure (over a period of 12 weeks, which includes 6 weeks waiting list and 6-week intervention)
An example is quality of life as measured by the Parkinson's Disease Questionnaire (PDQ-39). This questionnaire assesses how often people with Parkinson's experience difficulties across 8 dimensions of daily living, among which quality of life. Higher scores on one of the dimensions indicate worse well-being on that specific dimension.
System Usability Scale (SUS) [Usability]
时间窗: After 6-week training
A 10-item questionnaire to measure usability of the Cue X training module, answered on a 5 point Likert scale (1 strongly disagree - 5 strongly agree). Minimum - maximum score: 10 - 50. Higher scores imply better usability of the Cue X software.
Adherence to the training programme
时间窗: During 6-week training
Actual exercise time as a percentage of prescribed exercise time. The prescribed exercise time is 30 minutes, 5 days a week.
Side effects as reported by participants [safety]
时间窗: During 6-week training
To measure safety of the Cue X training module
Patient-reported experience measures (PREMs)
时间窗: After 6-week training
Perceived effectiveness of the Cue X training programme through Likert scale reporting and semi-structured interview questions during weekly phone calls and a post-intervention interview.
Timed Up-and-Go test (TUG) [Gait-and-balance outcome measures]
时间窗: Change between pre-, mid- and post-training measure (over a period of 12 weeks, which includes 6 weeks waiting list and 6-week intervention)
To measure functional gait. Higher scores indicate worse functional gait.
Lindop Parkinson's Physiotherapy Assessment Scale (LPPAS) [Gait-and-balance outcome measures]
时间窗: Change between pre-, mid- and post-training measure (over 12 weeks, which includes 6 weeks waiting list and 6-week intervention)
To measure gait mobility. Higher scores indicate better gait mobility. Minimum - maximum score: 0 - 18
Targeted walking-related fall-risk assessment as measured by the Interactive Walkway
时间窗: Change between pre-, mid- and post-training measure (over a period of 12 weeks, which includes 6 weeks waiting list and 6-week intervention)
Targeted walking-related fall-risk assessment based on outcome measures of walking adaptability as determined with the Interactive Walkway (obstacle avoidance margins and success rates and stepping accuracy and walking speed during goal-directed stepping)
次要结局
- New Freezing of Gait Questionnaire (NFOGQ)(Change between pre-, mid- and post-training measure (over a period of 12 weeks, which includes 6 weeks waiting list and 6-week intervention))
- Five Times Sit to Stand Test (FTSTS)(Change between pre-, mid- and post-training measure (over a period of 12 weeks, which includes 6 weeks waiting list and 6-week intervention))
- Gait speed [Gait-modifying ability and data quality](Change between pre-, mid- and post-training measure (over 12 weeks, which includes 6 weeks waiting list and 6-week intervention))
- Step length [Gait-modifying ability and data quality](Change between pre-, mid- and post-training measure (over a period of 12 weeks, which includes 6 weeks waiting list and 6-week intervention))
- Movement Disorders Society Unified Parkinson Disease Rating Scale (UPDRS)(Change between pre-, mid- and post-training measure (over a period of 12 weeks, which includes 6 weeks waiting list and 6-week intervention))
- Activities-Specific Balance Confidence Scale (ABC)(Change between pre-, mid- and post-training measure (over a period of 12 weeks, which includes 6 weeks waiting list and 6-week intervention))
- Falls Efficacy Scale International (FES-I)(Change between pre-, mid- and post-training measure (over a period of 12 weeks, which includes 6 weeks waiting list and 6-week intervention))
- Physical Activity Scale for the Elderly (PASE)(Change between pre-, mid- and post-training measure (over a period of 12 weeks, which includes 6 weeks waiting list and 6-week intervention))
- Cadence [Gait-modifying ability and data quality](Change between pre-, mid- and post-training measure (over a period of 12 weeks, which includes 6 weeks waiting list and 6-week intervention))
- Step time [Gait-modifying ability and data quality](Change between pre-, mid- and post-training measure (over a period of 12 weeks, which includes 6 weeks waiting list and 6-week intervention))
研究者
dr. Daphne J. Geerse
Principal Investigator
VU University of Amsterdam