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

Sponsor

Nancy Mayo (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05801926

Collaborator

MedTeq (Industry), Healthy Brains for Healthy Lives (Other), Mitacs (Industry), PhysioBiometrics Inc. (Other)

100

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

4.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease	Device: Heel2Toe[TM] sensor	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Intervention Model Description:

Individual, blocked, stepped-wedgeIndividual, blocked, stepped-wedge

Masking:

None (Open Label)

Masking Description:

Everyone eventually gets the intervention, it is the order that is randomized. The outcome is gait quality measured directly from the sensor and is not affected by observers.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 31, 2023

Anticipated Primary Completion Date :

Jan 31, 2024

Anticipated Study Completion Date :

Jan 31, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Angular velocity of ankle at heel strike averaged over a walk of a least 50 steps [Change from baseline to 3 months, 6 months, 1 year]
degrees per second
Angular velocity of ankle during push-off averaged over a walk of a least 50 steps [Change from baseline to 3 months, 6 months, 1 year]
degrees per second
Angular velocity of ankle during foot swing averaged over a walk of a least 50 steps [Change from baseline to 3 months, 6 months, 1 year]
degrees per second
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 [Change from baseline to 3 months, 6 months, 1 year]
ratio of standard deviation to mean converted to percent.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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. -

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Division of Clinical Epidemiology	Montreal	Quebec	Canada	H3A 1A1
2	Research Institute of the McGill University Health Center, CORE, 5252 de Maisonneuve	Montréal	Quebec	Canada	H4A 3S5