External vs Internal-triggered Augmented-reality Visual Cues to Treat Freezing of Gait
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Stride Time Coefficient of Variation
研究概览
简要总结
Postural instability, freezing-of-gait (FOG), and falls are among the greatest unmet needs in Parkinson disease (PD). FOG eventually affects more than half of people with PD, and is notoriously difficult to treat pharmacologically or via deep brain stimulation. Visual cues do improve gait freezing, but their efficacy and adoption is limited because they are not practical to use in all real-world situations. There is a need for a cueing technique that is on-demand and discreet - only perceptible to the patient. Fortunately, recent technological advances in augmented-reality (AR) enable such an approach. In this study, state-of-the-art AR glasses will be used to project digital cues that are only visible to the wearer, to determine if they can improve FOG. 36 individuals with PD and FOG will be recruited to perform an obstacle-course gait task under six cue conditions: no cue, conventional cue, constant-on AR, patient-hand-triggered AR (turns on when patient clicks button), patient-eye-triggered AR (turns on when looking down), and examiner-triggered AR. The AR cue is a set of images that appear on the floor at a patient's feet, mimicking floor lines. Gait performance will be captured on video and via body-worn wireless sensors that detect how each limb is moving. The investigators will determine whether individuals are cue-able with conventional visual cues, whether intermittent cues outperform constant-on cues, and whether cues triggered by an examiner outperform cues triggered by patients themselves.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of PD
- •Presence of freezing of gait, defined as a score of ≥1 in MDS-UPDRS 2.13, or 3.
- •Can walk without assistance, OFF meds, based on yes/no verbal response
排除标准
- •Severity of gait impairment should not require dependency to walker or cane
- •Concomitant conditions that may affect significantly the evaluation of balance or gait, including orthopedic, rheumatologic or other neurological diseases
- •Contraindication to physical therapy
- •Severe bilateral visual impairment
- •Age < 21
- •Diagnosis of dementia
- •Not agreeable to having video taken of entire research visit
研究组 & 干预措施
Augmented-Reality Visual Cues
In this single-arm study, all participants will receive all interventions on the same day. They will be wearing an augmented-reality headset that will display a digital obstacle course. Walking performance will be captured with no visual cues, with conventional visual cues, and with augmented-reality visual cues.
干预措施: Constant Cue (Other)
Augmented-Reality Visual Cues
In this single-arm study, all participants will receive all interventions on the same day. They will be wearing an augmented-reality headset that will display a digital obstacle course. Walking performance will be captured with no visual cues, with conventional visual cues, and with augmented-reality visual cues.
干预措施: Patient hand-triggered (Other)
Augmented-Reality Visual Cues
In this single-arm study, all participants will receive all interventions on the same day. They will be wearing an augmented-reality headset that will display a digital obstacle course. Walking performance will be captured with no visual cues, with conventional visual cues, and with augmented-reality visual cues.
干预措施: Patient eye-triggered (Other)
Augmented-Reality Visual Cues
In this single-arm study, all participants will receive all interventions on the same day. They will be wearing an augmented-reality headset that will display a digital obstacle course. Walking performance will be captured with no visual cues, with conventional visual cues, and with augmented-reality visual cues.
干预措施: Examiner-triggered (Other)
Augmented-Reality Visual Cues
In this single-arm study, all participants will receive all interventions on the same day. They will be wearing an augmented-reality headset that will display a digital obstacle course. Walking performance will be captured with no visual cues, with conventional visual cues, and with augmented-reality visual cues.
干预措施: No Cue (Other)
Augmented-Reality Visual Cues
In this single-arm study, all participants will receive all interventions on the same day. They will be wearing an augmented-reality headset that will display a digital obstacle course. Walking performance will be captured with no visual cues, with conventional visual cues, and with augmented-reality visual cues.
干预措施: Conventional Cue (Other)
结局指标
主要结局
Stride Time Coefficient of Variation
时间窗: For each arm, during the single-day research visit only.
Marker of gait dysfunction, derived from kinematic recordings from body-worn wireless sensors.
Percent Time Freezing
时间窗: For each arm, during the single-day research visit only.
Marker of gait freezing, derived from video recordings of gait performance, and body-worn wireless sensors.
次要结局
- Freezing Index(For each arm, during the single-day research visit only.)
- Gait Velocity(For each arm, during the single-day research visit only.)
- Mean Stride Length(For each arm, during the single-day research visit only.)
- Total Distance Walked(For each arm, during the single-day research visit only.)
- Step Cadence(For each arm, during the single-day research visit only.)
- Number of Freeze Episodes(For each arm, during the single-day research visit only.)