임상시험 레이더

• 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.

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.

• The activPAL™ sensor and Medical Clearance Form will be collected.

• Outcome measures will include: 10-meter walk test for gait speed and characteristics without walking poles on the Zeno™ Walkway, 4-square step test without walking poles on the Zeno™ Walkway, and the 6-minute walk test with the portable Zeno™ Walkway in the test course loop, Ultium MyoMOTION™ sensors strapped on each wrist, and 2 to 4 Ultium MyoMUSCLE™ EMG sensors affixed to the trunk. Gait characteristics will concurrently be collected with the above tests performed on the respective Zeno™ Walkway. MyoMOTION™ sensors will collect arm swing data and MyoMUSCLE™ sensors will collect muscle activation data. (see Section 5.5 for details)

  • The manually collected data will be recorded on the Outcome Measures spreadsheet.
  • Gait characteristic data is collected with the Zeno™ Walkway software (PKMAS).
  • Arm swing data is collected with the Ultium MyoMOTION™ software (MyoRESEARCH™ 4).
  • Trunk muscle activation data is collected with the Ultium MyoMUSCLE™ software (MyoRESEARCH™ 4).

• Within 2 days of the baseline assessment, participants will participate in a group training on the use of walking poles, including fitting and practice with the poles. The class will last no more than 60 minutes, although the PI/instructor will provide training for as long as participants desire.

  • Immediately before training, participants will perform the 10-meter walk test without poles on the Zeno™Walkway.
  • Immediately after training, the participants will repeat the 10-meter walk test with and without walking poles on the Zeno™ Walkway.
  • 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 walking for exercise during the study period. Pole use will not be restricted outside of the walking program.

Walking program period:

• 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 the PI via phone or email 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.

Visit 3 occurs at the conclusion of the 8-week walking program.

• Walking logs will be collected.
• Outcome measures will be collected, including: Trail Making Test Parts A and B, Activities Specific Balance Confidence Scale (ABC Scale), Parkinson Disease Questionnaire Shortened Form (PDQ-8), 10-meter walk test for gait speed and characteristics with and without walking poles on the Zeno™ Walkway, 4-square step test with and without walking poles on the Zeno™ Walkway, and the 6-minute walk test with the portable Zeno™ Walkway in the test course loop, Ultium MyoMOTION™ sensors strapped on each wrist, and 2 to 4 Ultium MyoMUSCLE™ EMG sensors affixed to the trunk. Gait characteristics will concurrently be collected with the above tests performed on the respective Zeno™ Walkway. MyoMOTION™ sensors will collect arm swing symmetry and amplitude and MyoMUSCLE™ sensors will collect muscle activation data.
• An ActivPAL™ sensor will be secured to the anterior thigh of the participants' 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.

Visit 4

• The ActivPAL™ sensor will be collected.
• Participants in the control group will be given a pair of walking poles for personal use.

At 3 months post-completion, participants will be contacted by email or phone to complete an ABC Scale and PDQ-8 questionnaire. Participants will be asked to estimate how many times in the past 2 weeks they went for an intentional walk and if they used the walking poles for those walks.