What side effects are associated with this type of intervention?

Common treatments for fall injury prevention and monitoring, such as the use of wearable devices like the Tango Belt, generally have minimal side effects. The primary concerns include skin irritation from prolonged wear, discomfort, and potential issues with device adherence. Additionally, there may be minor inconveniences related to device maintenance, such as charging and ensuring proper fit. Overall, these treatments are considered low-risk and are designed to improve safety and reduce the incidence of falls.

What prior FDA approvals exist?

The FDA has approved various devices and therapies aimed at preventing fall-related injuries, particularly in older adults. These include wearable technologies like hip protectors, which are designed to absorb impact and reduce the risk of hip fractures during falls. Additionally, there are balance training and physical therapy programs that have been endorsed to improve stability and reduce fall risk. While specific devices exactly like the Tango Belt may not be widely documented, the concept of using wearable technology for fall prevention is supported by existing FDA-approved interventions aimed at mitigating fall injuries.

What other types of research exist?

Promising alternatives to the Tango Belt for fall injury prevention and monitoring in 2024 include: 1) Smart insoles with embedded sensors that detect gait abnormalities and provide real-time feedback to prevent falls. 2) Advanced wearable devices like smartwatches or fitness trackers with fall detection algorithms and emergency alert systems. 3) Home-based sensor systems that use motion detectors and cameras to monitor movement patterns and detect falls, alerting caregivers or emergency services. 4) AI-powered mobile applications that analyze daily activity data to predict and prevent falls by suggesting personalized interventions.

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Behavioural Intervention

Tango Belt for Hip Injury Due to Falls

N/A

Waitlist Available

Led By Richard Stefanacci, DO, MGH,MBA, AGSF, CMD

Research Sponsored by ActiveProtective Technologies, Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests the Tango Belt, a wearable device for older adults at risk of falling, to see if it can prevent serious hip injuries. Participants will use the belt for several months. The study aims to find out if the belt can reduce fall-related injuries and hospital visits.

Who is the study for?

This trial is for people aged 65 or older who have had a fall-related fracture after age 50, or multiple falls in the past year with osteoporosis or similar bone conditions. They must be able to move with some assistance and have a waist size of 29-50 inches.

What is being tested?

The study tests the Tango Belt's safety and effectiveness in preventing hip injuries from falls. Participants will wear the belt for at least six months, except during bathing and charging, and adherence will be monitored.

What are the potential side effects?

While specific side effects are not detailed, adverse events related to wearing the Tango Belt such as discomfort, skin issues, or potential interference with mobility may be monitored.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Major hip injuries due to fall

Secondary study objectives

Accidental Falls

Number of hip fractures due to fall

Number of hospitalizations due to fall

Other study objectives

Accuracy of device fall discrimination

Balance confidence score changes

Device wear adherence

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention GroupExperimental Treatment1 Intervention

The intervention group will be assigned a Tango Belt to be worn around the waist for up to 24 hours a day (removed for bathing, charging of device and upon request) for 6 months. The Tango Belt (the "Device") is a wearable belt designed to enable safer mobility of geriatric individuals (≥ 65 years of age) at risk for fall injury by mitigating major hip injuries due to falls by deploying an airbag around the hips upon sensing a serious hip-impacting fall-in-progress to protect the hips from ground impact forces.

Group II: Control GroupActive Control1 Intervention

The the clinical site's electronic medical record (EMR) database will be reviewed determine their long-term care patient population's initial eligibility for meeting the study inclusion criteria beginning at the time frame 6 months prior to the institutional review board (IRB) approval date. Subjects eligible for the control group must meet the requirements of the inclusion and exclusion criteria except for the waist circumference and need for consent. Eligible subjects' electronic health records will be mined for the baseline, midpoint, and final study metrics.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tango Belt

2022

N/A

~140

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The Tango Belt is a fall prevention and monitoring device designed to reduce the risk of major hip injuries by providing real-time alerts and support during falls. Common treatments for fall injury prevention include wearable devices like the Tango Belt, which use sensors to detect falls and deploy protective measures, such as airbag systems, to cushion the impact. These devices are crucial for fall injury patients as they offer continuous monitoring, immediate response to falls, and can significantly reduce the severity of injuries, thereby improving patient safety and quality of life.