BioButton Device for Walking Problems

AM
CR
Overseen ByCarly Riedmann, MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Charles Lin
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the BioButton, a wearable device, to determine if it can detect walking problems caused by taking multiple medications. The researchers aim to find out if the device can effectively track movement and health data over 30 days. Individuals with documented walking issues who are not bedbound may be suitable for this trial. As an unphased trial, it offers participants the opportunity to contribute to innovative research that could enhance health monitoring technology.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the BioButton device is safe for identifying gait disturbances?

Research has shown that the BioButton device effectively monitors vital signs and detects health changes in various settings. Previous studies found that patients tolerated the device well, with no significant reports of harm or discomfort. The BioButton tracks heart rate and breathing during rest, aiding in the early identification of potential health issues.

The device has been tested in various groups, including children, for tracking physical activity and body position, demonstrating its reliability without causing problems. Overall, the BioButton appears to be a safe tool for monitoring health without causing issues for the wearer.12345

Why are researchers excited about this trial?

Researchers are excited about the BioButton device because it offers a cutting-edge way to monitor walking problems continuously. Unlike traditional treatments that rely on periodic clinical assessments, the BioButton provides real-time physiologic and gait data over 30 days, giving healthcare providers a more comprehensive view of a patient's condition. Additionally, this device is non-invasive and seamlessly integrates into a patient's daily routine, which could lead to more personalized and effective care. By involving nurses in the process, the trial also aims to assess the device's practicality in everyday clinical settings, potentially revolutionizing how walking issues are managed.

What evidence suggests that the BioButton is effective for identifying gait disturbances?

This trial will evaluate the BioButton device for its ability to track movement and body positions in patients with walking problems. Research has shown that the BioButton can accurately measure movement and may effectively identify walking issues, especially those caused by taking multiple medications. In this trial, patients in one arm will wear the BioButton continuously for 30 days to collect physiologic and gait data. Meanwhile, nurses in another arm will assist with the device's placement and removal to assess its feasibility for clinical care providers. While more studies are needed for adults, these early results are promising for understanding and addressing walking problems.14567

Who Is on the Research Team?

CL

Charles Lin, MD

Principal Investigator

UPMC, University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for adults over 18 who have documented gait issues in their medical records. It's not suitable for non-English speakers, those unable to consent due to cognitive problems, or individuals who are bedbound or can't stand.

Inclusion Criteria

I am older than 18 years.
My walking ability is documented in my medical records.

Exclusion Criteria

Non-English-speaking patients
I am bedbound and cannot stand up.
I am under 18 years old.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants wear the BioButton device continuously for 30 days to collect physiologic and gait data

4 weeks
Continuous monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • BioButton
Trial Overview The study tests the BioIntellisense BioButton, a wearable device that monitors various health parameters to detect gait disturbances caused by taking multiple medications.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Patient GroupExperimental Treatment1 Intervention
Group II: Nurse GroupExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Charles Lin

Lead Sponsor

Trials
1
Recruited
70+

Jewish Healthcare Foundation

Collaborator

Trials
1
Recruited
70+

Citations

Validation of the BioIntelliSense BioButton® device for ...The BioButton device accurately identified physical activity and body position in children and may be a useful tool to quantify physical activity as an outcome ...
BioButton Device for Walking Problems · Info for ParticipantsThis pilot study will explore the use of the BioIntellisense BioButton, a remote wearable multi-parameter monitor, to identify gait disturbances that occur as a ...
NCT06665685 | BioButton Among Nursing Home ResidentsBioButton is a remote wearable multi-parameter monitor, to identify gait disturbances that occur as a side effect of polypharmacy. This arm will provide care ...
BioButton Among Nursing Home Residents | MedPathThis pilot study will explore the use of the BioIntellisense BioButton, a remote wearable multi-parameter monitor, to identify gait disturbances ...
5.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/40303556/
Validation of the BioIntelliSense BioButton® device for ...The BioButton device accurately identified physical activity and body position in children and may be a useful tool to quantify physical activity as an outcome ...
BioButton® Rechargeable Instructions for UseHeart rate and respiratory rate data are only reported when the wearer is at rest and not reported during periods of significant motion or activity. • Press the ...
A Retrospective Observational Study of Continuous ...Wearable continuous vital sign monitoring with the BioIntelliSense BioButton system enables early detection of clinical deterioration.
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