Promoting BEST (BEtter, Faster, Longer, STronger) Walking for People With Parkinson's

This project aims to improve how people with Parkinson's Disease (PD) walk. The global aim is to identify obstacles and solutions for people with PD for adopting technology to track and improve their gait to make them better and safer walkers. To meet this aim members of Parkinson Quebec will be surveyed about their technology readiness, physical, cognitive, and psychological health, and rehabilitation access. The survey should not take more than 20 minutes to complete on the web. Subsequently, a random sample of 100 survey participants will be offered a wearable device, the Heel2ToeTM sensor, designed to improve gait quality. This device emits a beep when a proper step is taken. This external cue reinforces the adoption of an adequate gait. In addition to the device, participants will be offered 5 sessions of telemonitoring to help them use the device optimally. Monitoring of use and outcomes will be over 3 months and the sensor is theirs to keep.

Study Overview

• Status: Enrolling by invitation
• Conditions: Parkinson Disease
• Intervention / Treatment: Device: Heel2Toe[TM] sensor

Detailed Description

The global aim of this research program is to identify technical, attitudinal, and motivational obstacles and solutions for people with PD for adopting technology to improve gait and to quantify changes in gait biomechanics that will make participants better and safer walkers, ultimately improving physical function, physical activity, motivation, and quality of life.

Specific objective: Among members of the PQ who meet the criteria for technology readiness and have sufficient walking capacity to use the Heel2ToeTM sensor at home, the objectives are to estimate the extent to which they: (1) require support from the technology and rehabilitation team to optimize use; (2) use the sensor; (3) and change gait pattern, walking behaviours, motivation and functional and quality of life indicators over a period of 3 months.

Design: An individualized, blocked, stepped-wedge design will be used, a design favoured for implementation science questions 63,64 and applicable here as the team does not have the resources to implement the technology to all participants all at once. Parkinson Quebec has provided funds to provide sensors for 100 people. Variable size clusters of people will be formed and randomized to receive the Heel2Toe sensor, training, and remote supervised use, at intervals of 3 weeks. The cluster size will be randomly determined ranging from 4 to 10. As everyone selected for the implementation have already filled out the survey, there is a common data set at project entry. This assessment will be repeated prior to being entered into the Heel2Toe phase and then 3 months later.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3A 1A1
      • Division of Clinical Epidemiology
    • Montréal, Quebec, Canada, H4A 3S5
      • Research Institute of the McGill University Health Center, CORE, 5252 de Maisonneuve

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Technology readiness will be determined by the following criteria:

• has wifi
• has a smartphone that is recent enough to support the technology or willing to acquire one
• uses apps on the smartphone on most days of the week with or without the aid of another person
• positively endorses the question "Are you interested in learning new things?"58 and "I walk outdoors on most days, weather permitting."

To screen participants for their capacity to use the Heel2Toe sensor, participants meeting the technology readiness criteria will be instructed to send a smartphone video of themselves doing a modified Timed-up-an-Go test65 in which the person, stands up from a chair, walks minimum of 10 meters (original TUG is 3 m.), turns, walks back to the chair, and sits down (long-TUG).

Exclusion Criteria:

• unable to do the long TUG without assistance or need for a walking aid
• unable to recover balance independently from a perturbation during execution of the long TUG
• unable to reinitiate movement without assistance or without losing balance during a freezing event occurring during the long TUG. -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immediate assignment; Within this block, half are assigned to receive the sensor right away.	Device: Heel2Toe[TM] sensor; Heel2Toe is a new generation of wearables that provides real-time auditory feedback when the person takes a good step, one in which the step is initiated with a strong heel strike.
Active Comparator: Delayed assignment; Within this block, half are assigned to receive the sensor after a delay of 3 to 4 weeks	Device: Heel2Toe[TM] sensor; Heel2Toe is a new generation of wearables that provides real-time auditory feedback when the person takes a good step, one in which the step is initiated with a strong heel strike.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Angular velocity of ankle at heel strike averaged over a walk of a least 50 steps	degrees per second	Change from baseline to 3 months, 6 months, 1 year
Angular velocity of ankle during push-off averaged over a walk of a least 50 steps	degrees per second	Change from baseline to 3 months, 6 months, 1 year
Angular velocity of ankle during foot swing averaged over a walk of a least 50 steps	degrees per second	Change from baseline to 3 months, 6 months, 1 year
Co-efficient of variation of angular velocity of ankle during three phases of gait cycle, heel-strike, push-off, swing averaged over a walk of at least 50 steps	ratio of standard deviation to mean converted to percent.	Change from baseline to 3 months, 6 months, 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motivation	Starkstein Apathy Scale (0-42, higher worse)	Change from baseline to 3 months, 6 months, 1 year
Apathy	Motivation Inventory (0-68, higher worse)	Change from baseline to 3 months, 6 months, 1 year
Walking behaviour	Daily step count	Change from baseline to 3 months, 6 months, 1 year
Health-related quality of life (HRQL)	EQ-5D-5L (0-1; higher is better)	Change from baseline to 3 months, 6 months, 1 year
Health-related quality of life (HRQL)better)	Preference-based Parkinson Index (0-100; higher is better)	Change from baseline to 3 months, 6 months, 1 year
Self-reported Cognitive Ability	Communicating Cognitive Concerns (C3Q: 0-36, higher is better)	Change from baseline to 3 months, 6 months, 1 year
Cognitive Performance Test	Symbol Digit Modality Test (errors in 90 seconds)	Change from baseline to 3 months, 6 months, 1 year

Collaborators and Investigators

• Sponsor: Nancy Mayo
• Collaborators: Mitacs; MedTeq; Healthy Brains for Healthy Lives; PhysioBiometrics Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2023
• Primary Completion (Anticipated): January 31, 2024
• Study Completion (Anticipated): January 31, 2024

Study Registration Dates

• First Submitted: February 4, 2023
• First Submitted That Met QC Criteria: March 24, 2023
• First Posted (Actual): April 6, 2023

Study Record Updates

• Last Update Posted (Actual): April 6, 2023
• Last Update Submitted That Met QC Criteria: March 24, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: gait; wearable; feedback; walking; motivation
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: A00-B37-22A / eRAP 22-04-037

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No