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Behavioural Intervention
Wearable Device & Telemonitoring for Parkinson's Disease
N/A
Waitlist Available
Research Sponsored by Nancy Mayo
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to 3 months, 6 months, 1 year
Awards & highlights
Study Summary
This trial aims to improve how people with Parkinson's Disease walk, by surveying their needs and offering them a wearable device & telemonitoring.
Who is the study for?
This trial is for people with Parkinson's Disease who have access to Wi-Fi and a modern smartphone, use apps regularly, are interested in learning new things, and walk outdoors often. It's not for those who need help or walking aids during the 'long TUG' test or can't recover balance independently after a disturbance.Check my eligibility
What is being tested?
The study tests the Heel2Toe[TM] sensor, a wearable device that beeps to signal correct steps and improve gait quality. Participants will also receive five telemonitoring sessions over three months to optimize device usage. The survey assesses technology readiness and health factors.See study design
What are the potential side effects?
Since this intervention involves using a non-invasive wearable device and telemonitoring sessions without medication or invasive procedures, significant side effects are not anticipated. However, individual experiences may vary based on comfort with technology.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline to 3 months, 6 months, 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to 3 months, 6 months, 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Angular velocity of ankle at heel strike averaged over a walk of a least 50 steps
Angular velocity of ankle during foot swing averaged over a walk of a least 50 steps
Angular velocity of ankle during push-off averaged over a walk of a least 50 steps
+1 moreSecondary outcome measures
Apathy
Cognitive Performance Test
Health-related quality of life (HRQL)
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Immediate assignmentExperimental Treatment1 Intervention
Within this block, half are assigned to receive the sensor right away.
Group II: Delayed assignmentActive Control1 Intervention
Within this block, half are assigned to receive the sensor after a delay of 3 to 4 weeks
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Who is running the clinical trial?
Healthy Brains for Healthy LivesUNKNOWN
Nancy MayoLead Sponsor
MedTeqIndustry Sponsor
7 Previous Clinical Trials
418 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have access to a wifi connection.You can't regain your balance on your own after being pushed or pulled during a specific walking test.You cannot walk for a long time without help or a walking aid.This criterion is not clear. Can you provide more context or clarify the language used?You enjoy learning new things and usually go for a walk outside most days, as long as the weather is good.You can't start moving again on your own or keep your balance after a freezing episode during a long TUG (Timed Up and Go) test.
Research Study Groups:
This trial has the following groups:- Group 1: Delayed assignment
- Group 2: Immediate assignment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What goal is the clinical trial attempting to achieve?
"This prospective medical trial will assess outcomes over an approximate 3 month, 6 month, and 1 year period. The primary endpoint is angular velocity of the ankle during push-off while walking at least 50 steps. Secondary endpoints include apathy as indicated by Motivation Inventory scores (0-68; higher values indicate worse performance), daily step count to measure gait behaviour, and EQ-5D-5L evaluations for Health Related Quality of Life (HRQL) measurements (ranging 0 to 1 with higher numbers indicating better health)."
Answered by AI
Are there any openings currently available for involvement in this medical trial?
"The clinicaltrials.gov website confirms that this trial, which was first posted on January 31st 2023, is not currently seeking participants. However, 496 other studies are presently enrolling patients at this time."
Answered by AI
Who else is applying?
What site did they apply to?
Research Institute of the McGill University Health Center, CORE, 5252 de Maisonneuve
What portion of applicants met pre-screening criteria?
Met criteria
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