Effects of an Independent Walking Program With Walking Poles in People With Parkinson Disease

Effects of an Independent Walking Program With Walking Poles in People With Parkinson Disease

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.

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.

• All participants (intervention and control) will be asked to participate in at least 3 days of intentional walking exercise for the subsequent 8 weeks. Each participant will be given a log (see attached) to record their walking frequency and duration, rating of perceived exertion (RPE), notes, and any adverse events. Participants will be educated on the RPE scale and provided with a laminated RPE scale (see attached). All participants will be instructed to contact a designated study member via phone or email as soon as possible if an adverse event occurs. Events are defined as "Illness, injury, or falls" and contact information is provided on each page of the log.
• Participants will be contacted by a study member (see Check-in Script) by email (preferred) or phone (if participant does not use email or does not respond to email within 48 hours) at the end of weeks 1, 2, 4 and 6.

At conclusion of the 8-week walking program participants will return for reassessment.

• Walking logs will be collected.
• The MoCA version 8.2, 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, Timed-up-and go (TUG), TUG with a cognitive task, and the 10-meter walk test with and without poles, 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) and 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 in the control group will be provided a pair of walking poles for personal use.

Three-months following walking-program conclusion

• Self-reported outcome measure will include: Activities Specific Balance Confidence Scale (ABC Scale) and 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
• The MoCA version 8.3, 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, Timed-up-and go (TUG), TUG with a cognitive task, and the 10-meter walk test with and without poles, and the Backward Walk Test. Heart rate will be collected with a Polar heart rate monitor chest strap during the 6-minute walk test.
• Participants will answer questions:
• "How many times have you fallen in the past 3 months?"
• "How often in the past month do you intentionally walk for exercise?"
• "What percentage in the past month do you use poles when intentionally walking for exercise?"
• "Please share any thoughts you would like the study team to know about your experience using walking poles."

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.