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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05801926
• Other study ID #: A00-B37-22A / eRAP 22-04-037
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 31, 2023
• Est. completion date: January 31, 2024

Study information

• Verified date: March 2023
• Source: McGill University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: January 31, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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. -

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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.

Locations

Country	Name	City	State
Canada	Division of Clinical Epidemiology	Montreal	Quebec
Canada	Research Institute of the McGill University Health Center, CORE, 5252 de Maisonneuve	Montréal	Quebec

Sponsors (5)

Lead Sponsor	Collaborator
Nancy Mayo	Healthy Brains for Healthy Lives, MedTeq, Mitacs, PhysioBiometrics Inc.

Country where clinical trial is conducted

Canada, 

Outcome

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