Accessing Mobility Using Wearable Sensors (NCT04306588) | Clinical Trial Compass
WithdrawnPhase 1/2
Accessing Mobility Using Wearable Sensors
Stopped: The PI moved to another institution
United States0Started 2018-05-21
Plain-language summary
This study will examine whether wearable sensors can be used to track changes in cognitive-motor performance in response to a disease or an intervention.
The investigators specific aims are twofold, first aim to explore whether and how a clinical condition such as Chronic obstructive pulmonary disease (COPD) or Congestive Heart Failure (CHF) may impact motor-cognitive performance measurable using validated wearable devices (e.g., LEGSys, BalanSENS, and Frailty Meter). Second, the investigators will explore whether an exercise intervention provided via tele-medicine (tele-rehabilitation) can enhance motor-cognitive performance.
Who can participate
Age range
18 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:
* Any individual 18 years old or 65+ older is eligible to participate.
* Must be diagnosed with a chronic illness such as COPD or CHF.
* Should be refereed to one of the tele-rehabilitation program offered at VA-Houston.
The investigators will be enrolling veteran subjects
Exclusion Criteria:
* Non-ambulatory (unable to walk with or without assistance a distance of at least 10 meter).
* Unlikely to fully comply with the protocol (e.g., long-distance travel if multiple follow-up visits are required)
* Unwilling to provide informed consent.
* Severe visual and hearing problems who may not be able to interact with tele-rehabilitation.
* Unstable medical region (those who may change medication over next 12 weeks).
* Severe cognitive impairment and psychiatric problems who may not be able to follow tele-rehabilitation instructions based on judgement of clinical investigators.
* Participating in another active intervention that may affect cognitive-motor performance, and those who do not have capacity to consent.
The investigators will not exclude patients with internal devices such as a deep brain stimulator or electronic devices for pain management, but the investigators will not be placing Bioharness device in people with such conditions.
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.