Parkinson DiseaseNCT05801926
Promoting BEST (BEtter, Faster, Longer, STronger) Walking for People With Parkinson's
A study testing Heel2Toe[TM] sensor in people with Parkinson Disease, run by Nancy Mayo at 2 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Heel2Toe[TM] sensor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesCanada
- Study dates
- 31 Jan 2023to 31 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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. -
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Division of Clinical Epidemiology
Montreal, Quebec, H3A 1A1
Research Institute of the McGill University Health Center, CORE, 5252 de Maisonneuve
Montreal, Quebec, H4A 3S5
About this study
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.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- Heel2Toe[TM] sensor
- Keywords
- gait, walking, wearable, feedback, motivation
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heel2Toe[TM] sensorDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Immediate assignment | Experimental | Within this block, half are assigned to receive the sensor right away. Receives: 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 Receives: Device: Heel2Toe[TM] sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Angular velocity of ankle at heel strike averaged over a walk of a least 50 steps
degrees per second
Measured: 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
Measured: 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
Measured: 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.
Measured: Change from baseline to 3 months, 6 months, 1 year
Secondary outcomes (7)
Motivation
Starkstein Apathy Scale (0-42, higher worse)
Measured: Change from baseline to 3 months, 6 months, 1 year
Apathy
Motivation Inventory (0-68, higher worse)
Measured: Change from baseline to 3 months, 6 months, 1 year
Walking behaviour
Daily step count
Measured: Change from baseline to 3 months, 6 months, 1 year
Health-related quality of life (HRQL)
EQ-5D-5L (0-1; higher is better)
Measured: 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)
Measured: Change from baseline to 3 months, 6 months, 1 year
Self-reported Cognitive Ability
Communicating Cognitive Concerns (C3Q: 0-36, higher is better)
Measured: Change from baseline to 3 months, 6 months, 1 year
Cognitive Performance Test
Symbol Digit Modality Test (errors in 90 seconds)
Measured: Change from baseline to 3 months, 6 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study start31 Jan 2023
- Primary completion31 Jan 2024 (estimated)
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Individual, blocked, stepped-wedge
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nancy Mayo
- Sponsor type
- University, hospital or other
- Collaborators
- MedTeq, Healthy Brains for Healthy Lives, Mitacs, PhysioBiometrics Inc.
- Responsible party
- Sponsor-investigator, Nancy Mayo, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05801926
- Sponsor's protocol ID
- A00-B37-22A / eRAP 22-04-037
- Status last verified
- Mar 2023
- First submitted
- 4 Feb 2023
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting BEST (BEtter, Faster, Longer, STronger) Walking for People With Parkinson's
- ClinicalTrials.gov ID
- NCT05801926
- Acronym / sponsor ID
- A00-B37-22A / eRAP 22-04-037
- Conditions
- Parkinson Disease
- Keywords
- gait, walking, wearable, feedback, motivation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Nancy MayoUniversity, hospital or other
- Collaborators
- MedTeq, Healthy Brains for Healthy Lives, Mitacs, PhysioBiometrics Inc.
- Study start
- 31 Jan 2023 (actual)
- Primary completion
- 31 Jan 2024 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 6 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Individual, blocked, stepped-wedge
| Arm | Type | Receives |
|---|---|---|
| Immediate assignment | Experimental | Device: Heel2Toe[TM] sensorWithin this block, half are assigned to receive the sensor right away. |
| Delayed assignment | Active comparator | Device: Heel2Toe[TM] sensorWithin this block, half are assigned to receive the sensor after a delay of 3 to 4 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (3 listed)
- 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. -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heel2Toe[TM] sensorHeel2Toe 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. | Device | Delayed assignment, Immediate assignment |
Primary outcome
Angular velocity of ankle at heel strike averaged over a walk of a least 50 steps
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Change from baseline to 3 months, 6 months, 1 year
ratio of standard deviation to mean converted to percent.
7 secondary outcomes
Motivation
Time frame: Change from baseline to 3 months, 6 months, 1 year
Apathy
Time frame: Change from baseline to 3 months, 6 months, 1 year
Walking behaviour
Time frame: Change from baseline to 3 months, 6 months, 1 year
Health-related quality of life (HRQL)
Time frame: Change from baseline to 3 months, 6 months, 1 year
Health-related quality of life (HRQL)better)
Time frame: Change from baseline to 3 months, 6 months, 1 year
Self-reported Cognitive Ability
Time frame: Change from baseline to 3 months, 6 months, 1 year
Cognitive Performance Test
Time frame: Change from baseline to 3 months, 6 months, 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
- Individual participant dataSharing planned: No
Related trials for Parkinson Disease
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heel2Toe[TM] sensor in people with Parkinson Disease, run by Nancy Mayo at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Angular velocity of ankle at heel strike averaged over a walk of a least 50 steps (time frame: Change from baseline to 3 months, 6 months, 1 year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2023.