TURN-IT FOG: A Novel Intervention to Improve Turning in People With PD and Freezing of Gait
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 6
- 主要终点
- Patient- Perceived Freezing of Gait Severity
研究概览
简要总结
The goals of this clinical trial are to 1) learn how two different rehabilitation interventions for PD can reduce Freezing of Gait (FOG) in people with Parkinson's disease, as assessed by patients, clinicians, and wearable sensors, and 2) to explore whether two different rehabilitation intervention can reduce FOG and improve daily life mobility in people with FOG sufficiently to justify a clinical trial.
Participants will:
- Be randomly assigned to one of two intervention groups (turning-focused agility exercise or strength-based exercise)
- Have one-on-one training sessions three times per week for 6 weeks
- Perform in-lab assessments before beginning and after completing the study intervention
- Use wearable mobility sensors during daily life to measure their walking and balance
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of idiopathic PD from movement disorders neurologist with the United Kingdom Brain Bank criteria of bradykinesia with one or more of the following - rest tremor, rigidity, and balance problems not from visual, vestibular, cerebellar or proprioceptive conditions
- •reporting FOG in the New Freezing of Gait questionnaire (N-FOGQ)
- •Hoehn & Yahr stages II-IV
- •ages 50-80 years old
- •cognitive ability sufficient to participate in testing procedures and exercise classes
- •be willing and able to participate in exercise intervention 3x/week for 6 weeks
排除标准
- •Major musculoskeletal or neurological disorders, structural brain disease, epilepsy, acute illness or health history, other than PD, significantly affecting gait and turning (i.e., musculoskeletal disorder, vestibular problem, head injury, stroke, cardiac disease)
- •medical condition or medications that precludes moderate-intensity exercise
- •Montreal Cognitive Assessment (MoCA) ≤21 or inability to follow directions
- •excessive use of alcohol or recreational drugs
- •recent change in medication
- •inability to stand and walk for 2 minutes without an assistive device
结局指标
主要结局
Patient- Perceived Freezing of Gait Severity
时间窗: From enrollment/randomization through intervention; 8 weeks
Change in freezing of gait severity with the intervention (scored in likert scale by the patient; 3 = Much improved, 2 = Somewhat improved, 1 = Minimally improved, 0 = No change, -1 = Minimally worse, -2 = Somewhat worse, -3 = Much worse)
Clinician- Perceived Freezing of Gait Severity
时间窗: From enrollment/randomization through intervention; 8 weeks
Change in freezing of gait severity with the intervention (scored in likert scale by the clinician; 3 = Much improved, 2 = Somewhat improved, 1 = Minimally improved, 0 = No change, -1 = Minimally worse, -2 = Somewhat worse, -3 = Much worse
Sensors-based Freezing of gait severity
时间窗: From enrollment/randomization through intervention; 8 weeks
Freezing of Gait Index calculated during a 360 degrees turning in place from wearable sensors; continuous scale, with a higher positive score meaning a greater level of freezing of gait.
Patient- Perceived Freezing of Gait Severity
时间窗: From enrollment/randomization through intervention; 8 weeks
Change in freezing of gait severity with the intervention (scored in likert scale by the patient; 3 = Much improved, 2 = Somewhat improved, 1 = Minimally improved, 0 = No change, -1 = Minimally worse, -2 = Somewhat worse, -3 = Much worse)
Clinician- Perceived Freezing of Gait Severity
时间窗: From enrollment/randomization through intervention; 8 weeks
Change in freezing of gait severity with the intervention (scored in likert scale by the clinician; 3 = Much improved, 2 = Somewhat improved, 1 = Minimally improved, 0 = No change, -1 = Minimally worse, -2 = Somewhat worse, -3 = Much worse
Sensors-based Freezing of gait severity
时间窗: From enrollment/randomization through intervention; 8 weeks
Freezing of Gait Index calculated during a 360 degrees turning in place from wearable sensors; continuous scale, with a higher positive score meaning a greater level of freezing of gait.
次要结局
- Time Spent in FOG during daily life(From enrollment/randomization through intervention; 8 weeks)
研究者
Martina Mancini
Associate Professor
Oregon Health and Science University