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

Primary Purpose

Parkinson Disease

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Heel2Toe[TM] sensor
Sponsored by
Nancy Mayo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring gait, walking, wearable, feedback, motivation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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. -

Sites / Locations

  • Division of Clinical Epidemiology
  • Research Institute of the McGill University Health Center, CORE, 5252 de Maisonneuve

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Immediate assignment

Delayed assignment

Arm Description

Within this block, half are assigned to receive the sensor right away.

Within this block, half are assigned to receive the sensor after a delay of 3 to 4 weeks

Outcomes

Primary Outcome Measures

Angular velocity of ankle at heel strike averaged over a walk of a least 50 steps
degrees per second
Angular velocity of ankle during push-off averaged over a walk of a least 50 steps
degrees per second
Angular velocity of ankle during foot swing averaged over a walk of a least 50 steps
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
ratio of standard deviation to mean converted to percent.

Secondary Outcome Measures

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

Full Information

First Posted
February 4, 2023
Last Updated
March 24, 2023
Sponsor
Nancy Mayo
Collaborators
MedTeq, Healthy Brains for Healthy Lives, Mitacs, PhysioBiometrics Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05801926
Brief Title
Promoting BEST (BEtter, Faster, Longer, STronger) Walking for People With Parkinson's
Official Title
Promoting BEST (BEtter, Faster, Longer, STronger) Walking for People With Parkinson's
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 31, 2023 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nancy Mayo
Collaborators
MedTeq, Healthy Brains for Healthy Lives, Mitacs, PhysioBiometrics Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
gait, walking, wearable, feedback, motivation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Individual, 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.
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Immediate assignment
Arm Type
Experimental
Arm Description
Within this block, half are assigned to receive the sensor right away.
Arm Title
Delayed assignment
Arm Type
Active Comparator
Arm Description
Within this block, half are assigned to receive the sensor after a delay of 3 to 4 weeks
Intervention Type
Device
Intervention Name(s)
Heel2Toe[TM] sensor
Intervention Description
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.
Primary Outcome Measure Information:
Title
Angular velocity of ankle at heel strike averaged over a walk of a least 50 steps
Description
degrees per second
Time Frame
Change from baseline to 3 months, 6 months, 1 year
Title
Angular velocity of ankle during push-off averaged over a walk of a least 50 steps
Description
degrees per second
Time Frame
Change from baseline to 3 months, 6 months, 1 year
Title
Angular velocity of ankle during foot swing averaged over a walk of a least 50 steps
Description
degrees per second
Time Frame
Change from baseline to 3 months, 6 months, 1 year
Title
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
Description
ratio of standard deviation to mean converted to percent.
Time Frame
Change from baseline to 3 months, 6 months, 1 year
Secondary Outcome Measure Information:
Title
Motivation
Description
Starkstein Apathy Scale (0-42, higher worse)
Time Frame
Change from baseline to 3 months, 6 months, 1 year
Title
Apathy
Description
Motivation Inventory (0-68, higher worse)
Time Frame
Change from baseline to 3 months, 6 months, 1 year
Title
Walking behaviour
Description
Daily step count
Time Frame
Change from baseline to 3 months, 6 months, 1 year
Title
Health-related quality of life (HRQL)
Description
EQ-5D-5L (0-1; higher is better)
Time Frame
Change from baseline to 3 months, 6 months, 1 year
Title
Health-related quality of life (HRQL)better)
Description
Preference-based Parkinson Index (0-100; higher is better)
Time Frame
Change from baseline to 3 months, 6 months, 1 year
Title
Self-reported Cognitive Ability
Description
Communicating Cognitive Concerns (C3Q: 0-36, higher is better)
Time Frame
Change from baseline to 3 months, 6 months, 1 year
Title
Cognitive Performance Test
Description
Symbol Digit Modality Test (errors in 90 seconds)
Time Frame
Change from baseline to 3 months, 6 months, 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. -
Facility Information:
Facility Name
Division of Clinical Epidemiology
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 1A1
Country
Canada
Facility Name
Research Institute of the McGill University Health Center, CORE, 5252 de Maisonneuve
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4A 3S5
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

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

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