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
- 1
- 主要终点
- Six Minute Walk Test
研究概览
简要总结
Study Purpose: The purpose of the study is to compare changes in 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: Measurements will be taken of you while you are walking. You will be given tests and questionnaires about your movement and thinking. 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, movement, and thinking measurements will be collected as before the walking program.
Follow-up: The same measures of walking, movement, and thinking will be taken 3-months after ending the walking program.
详细描述
Enrolled participants will complete the following Initial assessment
- Participant demographics will be collected and include age, weight, height, foot length, gender, years since diagnosis, daily Parkinson medication, deep brain stimulation status, and the following questions: "How many times have you fallen in the past 3 and 6 months?", "Are you comfortable using walking/hiking poles?" and "How many days per week do you participate in intentional exercise?"
- The Montreal Cognitive Assessment (MoCA) version 8.1 will be administered. If participant scores >18 (the cutoff score for mild cognitive impairment (MCI), they will continue in the study.
- The MDS-UPDRS Part III and Trail Making Test Part A and B will be administered.
- Outcome measures performed by walking on the GAITRite™ Walkway with Movella Xsens™ Bluetooth motion sensors (worn on upper back, lower back, arms, and legs) will include: 6-minute walk test (6 MWT), Timed-up-and go (TUG), TUG with a cognitive task, and the 10-meter walk test (10 MWT), and the Backward Walk Test. Heart rate will be collected with a Polar heart rate monitor chest strap during the 6-minute walk test.
- Self-reported outcome measure will include: Activities Specific Balance Confidence Scale (ABC Scale), Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Patient Questionnaire (Part IB and II), the Revised Oswestry Disability Index, and the Freezing of Gait Questionnaire.
- Participants will be trained on the use of walking poles, and then practice with the poles. The technique taught will be with the poles are held in front of the body, perpendicular to the ground, and swung in a reciprocal pattern. This initial training will last no more than 30 minutes and will include 10 minutes of independent pole practice.
Participants will return within a 14-day window for group or individual training walking with poles.
- Outcome measures performed on the GAITRite™ Walkway prior to training will include: 10 MWT with and without poles.
- Participant will train until they can demonstrate independent starting, >%50 correct technique and 100% self-correction within 3 missteps without cuing during 2 consecutive passes of 10 meters with a U-turn between passes.
- Participants will then perform 10 minutes of independent poling practice.
- Outcome measures performed on the GAITRite™ Walkway after training will include: 10 MWT with and without poles.
- After training and the gait assessment data are collected, the study group allocation will be revealed to each participant by a study member not involved in the assessment data collection.
- Participants randomized into the walking pole group will be provided with the poles for home use and asked to use the poles during all intentional walking for exercise during the study period. Pole use will not be restricted outside of the walking program.
The participants will participate in an independent walking program period for 8-weeks.
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
- •English-speaking, diagnosis of Parkinson disease, ability to walk safely and independently with or without a cane, and medically cleared to participate in an independent walking program. Participants must be physically present in the USA at the time of assessment.
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), regular (>30%) use of walking poles during walking for exercise for the prior 6 months, weight of more than 320 pounds or height more than 6'4", unable to participate in walking for more than 7 consecutive days during the study period (ie, traveling, scheduled surgery), anticipated change in Parkinson-specific medication (including additions, removals, or changes in dosage) during the intervention period, a change in deep brain stimulation (DBS) parameters during the intervention.
研究组 & 干预措施
Walking Poles
Participants who will be using walking poles during the independent walking program
干预措施: Independent walking program using walking poles (Behavioral)
No Walking Poles
Participants who will not be using walking poles during the independent walking program
干预措施: Independent walking program without walking poles (Behavioral)
结局指标
主要结局
Six Minute Walk Test
时间窗: Prior to initiation of 8 week walking program, immediately upon completion, and 3 months after completion.
Measurement of distance walked in 6 minutes, a reflection of functional capacity.
次要结局
- Gait Characteristic - gait speed(Prior to initiation of 8 week walking program, immediately upon completion, and 3-months after completion.)
- Backward Walk Test(Prior to initiation of 8 week walking program, immediately upon completion, and 3 months after completion.)
- Timed Up and Go(Prior to initiation of 8 week walking program, immediately upon completion, and 3 months after completion.)
- Cognitive Timed Up and Go(Prior to initiation of 8 week walking program, immediately upon completion, and 3-months after completion.)
- Montreal Cognitive Assessment(Prior to initiation of 8 week walking program, immediately upon completion, and 3 months after completion.)
- The MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)(Prior to initiation of 8 week walking program, immediately upon completion, and 3 months after completion.)
- Activity-specific Balance Confidence Scale(Prior to initiation of 8 week walking program, immediately upon completion, and 3 months after completion.)
- Arm swing(Prior to initiation of 8 week walking program, immediately upon completion, and 3 months after completion.)
- Descriptive Gait Characteristics(Prior to initiation of 8 week walking program, immediately upon completion, and 3 months after completion.)
- Freezing of Gait Questionnaire(Prior to initiation of 8 week walking program, immediately upon completion, and 3-months after the completion.)
- Revised Oswestry Disability Index(Prior to initiation of 8 week walking program, immediately upon completion, and 3-months after the completion.)