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

NCT05801926 | Unknown

• 1 other identifier: A00-B37-22A / eRAP 22-04-037
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Parkinson Disease

Keywords

gait; walking; wearable; feedback; motivation

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (7)

• Motivation

  Change from baseline to 3 months, 6 months, 1 year

• Apathy

  Change from baseline to 3 months, 6 months, 1 year

• Walking behaviour

  Change from baseline to 3 months, 6 months, 1 year

• Health-related quality of life (HRQL)

  Change from baseline to 3 months, 6 months, 1 year

• Health-related quality of life (HRQL)better)

  Change from baseline to 3 months, 6 months, 1 year

Study Arms (2)

Immediate assignment

EXPERIMENTAL

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

Device: Heel2Toe[TM] sensor

Delayed assignment

ACTIVE COMPARATOR

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

Device: Heel2Toe[TM] sensor

Interventions

Heel2Toe[TM] sensor DEVICE

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.

Delayed assignment; Immediate assignment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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. -

Sponsors & Collaborators

• Nancy Mayo: lead
• MedTeq: collaborator
• Healthy Brains for Healthy Lives: collaborator
• Mitacs: collaborator
• PhysioBiometrics Inc.: collaborator

Study Sites (2)

Division of Clinical Epidemiology

Montreal, Quebec, H3A 1A1, Canada

Location

Research Institute of the McGill University Health Center, CORE, 5252 de Maisonneuve

Montreal, Quebec, H4A 3S5, Canada

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: James McGill Professor

Model Details: Individual, blocked, stepped-wedge

Study Record Dates

• First Submitted: February 4, 2023
• First Posted: April 6, 2023
• Study Start: January 31, 2023
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: April 6, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)