An interventional study of Heel2Toe[TM] sensor in Parkinson Disease, sponsored by Nancy Mayo. Status unknown at 2 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-06.
Sponsored by Nancy Mayo · Not applicable, Interventional, and Treatment
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.
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.
4,488 studies on the registry are indexed under Parkinson Disease; 1,083 are open to participants now.
This study's planned enrollment of 100 is above the median of 40 across 3,295 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →This is the only study on the registry with Nancy Mayo as lead sponsor.
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Technology readiness will be determined by the following criteria:
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:
Within this block, half are assigned to receive the sensor right away.
Device: Heel2Toe[TM] sensor
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.
Angular velocity of ankle at heel strike averaged over a walk of a least 50 steps
degrees per second
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: Change from baseline to 3 months, 6 months, 1 year
Motivation
Starkstein Apathy Scale (0-42, higher worse)
Time frame: Change from baseline to 3 months, 6 months, 1 year
Apathy
Motivation Inventory (0-68, higher worse)
Time frame: Change from baseline to 3 months, 6 months, 1 year
Walking behaviour
Daily step count
Time frame: Change from baseline to 3 months, 6 months, 1 year
Health-related quality of life (HRQL)
EQ-5D-5L (0-1; higher is better)
Time frame: 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)
Time frame: Change from baseline to 3 months, 6 months, 1 year
Self-reported Cognitive Ability
Communicating Cognitive Concerns (C3Q: 0-36, higher is better)
Time frame: Change from baseline to 3 months, 6 months, 1 year
Cognitive Performance Test
Symbol Digit Modality Test (errors in 90 seconds)
Time frame: Change from baseline to 3 months, 6 months, 1 year
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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