Falls Prevention: Gait-Synchronized Vibration System (NCT02635113) | Clinical Trial Compass
WithdrawnNot Applicable
Falls Prevention: Gait-Synchronized Vibration System
Stopped: Lack of funding
0Started 2017-11-30
Plain-language summary
The purpose of this study is to develop an abnormal gait detection algorithm and a vibratory stimulation system on a lower limb to improve gait stability and prevent falls. The investigators want to detect, assess and communicate fall risk indicators obtained via the shoe sensors, and assess effectiveness of a gait synchronized vibration system to the plantar surface in reducing fall risk.The system consists of a gait measurement module, an abnormal gait detection module, and a vibratory stimulation module.
Who can participate
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Individuals aged 65 or greater.
. Low balance confidence (scores \<80%) on the ABC Balance Confidence Scale
. Berg Balance Scale (BBS) scores between 21 (moderate fall risk) and 56 (low fall risk).
Exclusion criteria
. No internal implantable device (i.e. Pacemaker, Intrathecal Baclofen Pump)
. Significant painful arthritis (scores 15 or greater) as per the Short Arthritis Assessment Scale.
. Significant cognitive deficits (scores \<2) as per Ascertain Dementia 8 (AD8) questionnaire.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Test the efficacy of a wearable shoe sensor to detect initiation of abnormal gait patterns that increase the likelihood of falls
Timeframe: 1 hour; The entire protocol for testing the PD shoe is expected to be less than 2hours.
. Significant visual field deficits as per the Humphrey Visual Field Analysis or significant uncorrected visual acuity deficits as per the Snellen Eye Chart.
. Current treatment with anticoagulation medication
. Parkinson's Disease or known Peripheral Neuropathy
. Limitations to exercise related to cardiac, neurological or pulmonary diseases