Effects of an Independent Walking Program With Walking Poles in People With Parkinson Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Gait Characteristic - gait speed
研究概览
简要总结
- Study Purpose: The purpose of the study is to compare changes in activity levels and walking in people with Parkinson disease after an 8-week independent walking program with or without using walking poles.
- Major parts of the Study:
Before the walking program: You will wear an activity sensor on your upper leg for one week to track activity levels. Measurements will be taken of you while you are walking. If you are placed in the walking pole group, you will be trained on how to use walking poles.
Independent walking program: You will be asked to walk at least 3 times each week for 8 weeks and keep a log of your walking. If you are in the walking pole group, you will walk with the poles.
After the walking program: Your walking measurements will be collected as before the walking program. You will wear an activity sensor for one week.
详细描述
The study will be comprised of a pre-visit distribution of the consent form with an opportunity to ask questions during a phone conversation, and 4 in-person visits in total: (1) consent signature, written outcomes, and activity sensor placement, (2) activity sensor collection and initial baseline testing, (3) post-intervention testing, written outcomes, and activity sensor placement, and (4) activity sensor collection. Each participant will be assigned a study ID number consisting of a root '0203' appended by the participant number (ie, '01', '02', etc), assigned in order of initial testing. (e.g., the first participant ID will be 020301).
Prior to Visit 1, the consent form will be emailed (preferred) or mailed to the potential participant for review. If the potential participant wishes, they will be contacted by phone by the PI or a co-Investigator and the study will be explained, inclusion and exclusion criteria will be reviewed and recorded on the Eligibility Form (see attached), and the potential participant will be given the opportunity to ask questions regarding the study.
Visit 1 will include answering any outstanding questions and obtaining a signature indicating informed consent, obtaining participant demographics and written outcome measures, application of the activity sensor, and giving the participant the Medical Clearance Form.
- Participants will be asked to verbalize understanding and will be asked if they have any questions about the study before being asked to sign the Consent Form.
- Participant demographics will include age, weight, height, gender, years since diagnosis, Hoehn & Yahr stage, daily levodopa intake and the following questions: "Are you comfortable using walking/hiking poles?" and "How many days per week do you participate in intentional exercise?" These data will be recorded on the Outcome Measures Spreadsheet (see attached).
- Written outcome measure will include: Trail Making Test Parts A and B, Activities Specific Balance Confidence Scale (ABC Scale), Parkinson Disease Questionnaire Shortened Form (PDQ-8)
- An activPAL™ sensor will be secured to the anterior thigh of their less-involved side (if applicable). Medical tape or transparent film dressing will be used to secure the sensor. Showering with the sensor on is permitted. If the participant may submerge in water (i.e., bathing or swimming) during the week or if the participant prefers, transparent film dressing will be used to attach and waterproof the sensor.
- The Medical Clearance Form (see attached) will be provided to the participant for completion by their provider. The Medical Clearance Form must be returned to the PI prior to the walking program portion of the study.
Visit 2 will include baseline assessments and study group assignment.
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 (Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of Parkinson disease,
- •ability to walk independently with or without a cane,
- •receive medical clearance to participate in an independent walking,
- •English or Spanish language proficiency at 8th grade level.
排除标准
- •diagnosis of any neurological disease other than PD (including but not limited to stroke, dementia, and multiple sclerosis; mild cognitive impairment is not excluded),
- •use of walking poles during walking for exercise more than 4 times during the last year (hiking with poles permitted),
- •weight of more than 320 lb or height more than 6'4",
- •allergy to medical-grade adhesive,
- •unable to participate in walking for more than 5 consecutive days during the study period (ie, traveling, scheduled surgery),
- •a change in Parkinson medication that affects Levodopa levels (including additions, removals, or changes in dosage) during the study period.
结局指标
主要结局
Gait Characteristic - gait speed
时间窗: Prior to initiation of 8 week walking program and immediately upon completion.
Gait characteristics collected on Zenomat walkway, including gait speed (m/s)
Gait Characteristic - step length
时间窗: Prior to initiation of 8 week walking program and immediately upon completion.
Gait characteristics collected on Zenomat walkway, including step length (m)
Gait Characteristic - step symmetry
时间窗: Prior to initiation of 8 week walking program and immediately upon completion.
Gait characteristics collected on Zenomat walkway, including step symmetry (symmetry index, %)
Gait Characteristic - gait variability
时间窗: Prior to initiation of 8 week walking program and immediately upon completion.
Gait characteristics collected on Zenomat walkway, including gait variability (enhanced gait variability index)
次要结局
- Physical Activity(Upon enrollment for 1 week, followed by 8 week independent walking program with no activity monitoring, then upon walking program completion for 1 week.)
- Physical Activity - daily steps(Upon enrollment for 1 week, followed by 8 week independent walking program with no activity monitoring, then upon walking program completion for 1 week.)
- Physical Activity - daily sit to stands(Upon enrollment for 1 week, followed by 8 week independent walking program with no activity monitoring, then upon walking program completion for 1 week.)
- Physical Activity - activity score(Upon enrollment for 1 week, followed by 8 week independent walking program with no activity monitoring, then upon walking program completion for 1 week.)
- Four Square Step Test(Prior to initiation of 8 week walking program and immediately upon completion.)
- Arm swing(Prior to initiation of 8 week walking program and immediately upon completion.)
- Cervical and lumbar extensor muscle activation(Prior to initiation of 8 week walking program and immediately upon completion.)
- Activity-specific Balance Confidence Scale(Prior to initiation of 8 week walking program and immediately upon completion)
- Parkinson's Disease Questionnaire Short Form(Prior to initiation of 8 week walking program and immediately upon completion)
- Trail Making Test A(Prior to initiation of 8 week walking program and immediately upon completion)
- Trail Making Test B(Prior to initiation of 8 week walking program and immediately upon completion)