Tango Belt for Hip Injury Due to Falls

No longer recruiting at 9 trial locations

Overseen By REBECCA J TARBERT, PT, DPT

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: ActiveProtective Technologies, Inc

Must be taking: Osteoporosis medication

Disqualifiers: Age 64 or less, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special belt called the Tango Belt, designed to prevent serious hip injuries from falls. The belt deploys an airbag around the hips when it senses a fall, aiming to protect against major impacts. The trial targets older adults, particularly those with recent fall-related fractures or multiple falls, and those who might have bone issues like osteoporosis. Participants should be able to move around with or without assistance and fit within a specific waist size range. The study will evaluate the belt's safety and effectiveness over six months. As an unphased trial, it offers participants the opportunity to contribute to innovative safety solutions for fall prevention.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your medications, especially if they are for osteoporosis, but you should confirm with the study staff.

What prior data suggests that the Tango Belt is safe for preventing hip injuries due to falls?

Research shows that the Tango Belt is designed to lessen the impact of falls using an airbag system. Studies have found that this device greatly reduces serious hip injuries in older adults at high risk of falling. For example, one study reported a 90.9% decrease in major hip injuries among users.

Regarding safety, the Tango Belt appears well-tolerated. No significant reports of negative effects have emerged from wearing the device. This suggests that, so far, it is a safe choice for those seeking protection from hip injuries due to falls. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Tango Belt because it offers a novel approach to preventing hip injuries from falls, especially in older adults. Unlike traditional methods such as hip protectors or physical therapy, the Tango Belt is a wearable device that actively deploys an airbag around the hips during a fall, cushioning the impact. This smart technology enhances safety by sensing when a serious fall is happening and automatically protecting the hips, potentially reducing the severity of injuries. This proactive, technology-driven approach stands out from existing passive protection methods, offering a new level of mobility and confidence for those at risk.

What evidence suggests that the Tango Belt is effective for preventing hip injuries due to falls?

Research has shown that the Tango Belt, a wearable airbag belt, can greatly reduce hip injuries from falls in older adults. In this trial, participants in the intervention group will wear the Tango Belt, which studies have found decreases the risk of hip injuries from falls and lessens the need for medical care afterward. The belt detects a fall and inflates an airbag around the hips to soften the impact. Real-world evidence indicates that when the belt senses a serious fall, it inflates the airbags and alerts staff, often preventing injury. This makes it a promising tool for protecting older adults at high risk of falling. ^{2 3 4 6 7}

Who Is on the Research Team?

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

Principal Investigator

ActiveProtective Technologies, Inc

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Provides consent or their legally authorized representative provides consent on subject's behalf

Are under the care of the Investigational organization

You broke a bone from a fall after age 50, or you had one or more falls in the year before joining the study and have been diagnosed with osteoporosis or osteopenia, or are taking medication for osteoporosis.

Exclusion Criteria

You are 64 years old or younger.

Participation in a different clinical investigation that can conflict with this clinical study as determined by the Study Investigator and approved by the Sponsor

Does not provide consent, or legally authorized representative does not provide consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Adherence Phase

Participants must demonstrate a minimum of 64% adherence to the use of the Tango Belt within 14 days of initiation to fully enroll in the study

2 weeks

1 visit (in-person)

Treatment

Participants wear the Tango Belt continuously for at least 6 months, except during bathing, device charging, and as deemed by clinical staff

6 months

Quarterly visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Tango Belt

Trial Overview 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.

How Is the Trial Designed?

Group I: Intervention Group Experimental Treatment 2 Interventions

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 Group Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

ActiveProtective Technologies, Inc

Lead Sponsor

Trials

1

Recruited

130+

Avania

Industry Sponsor

Trials

59

Recruited

10,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40887039/

Mitigating Hip Injuries in High-Risk Older Adults The wearable airbag belt significantly reduced fall-related hip injuries and associated health care utilization in high-risk older adults.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1525861025003688

Mitigating Hip Injuries in High-Risk Older Adults: Clinical ... The wearable airbag belt significantly reduced fall-related hip injuries and associated health care utilization in high-risk older adults. These results suggest ...

3. ojin.nursingworld.org ojin.nursingworld.org/link/42a5ad4ecd714401b331ed4f916898cc.aspx

Tango Belt: A New Smart Hip Protector Solution | OJIN This article discusses evidence about the Tango Belt, a new hip protector solution, that protects patients from fall-related hip fractures.

4. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/97/NCT05245097/Prot_SAP_ICF_001.pdf

Mitigation of Major Hip Injury due to fall in an At-Risk, Older ... The study will investigate the safety and effectiveness of the Tango Belt with the primary and secondary endpoints being taken every 3 months and at the end of ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10109244/

Real World Evidence of Wearable Smartbelt for Mitigation ... The smartbelt detected an irrecoverable serious hip-impacting fall motion, deployed airbags and sent alerts of the fall. Nursing staff reported no injury ...

6. tangobelt.com tangobelt.com/

Tango® Belt - Wearable Hip Protection Device While other options put constraints on the user, the Tango Belt automatically senses a serious hip-impacting fall and deploys airbags to reduce impact forces.

7. ojin.nursingworld.org ojin.nursingworld.org/table-of-contents/volume-26-2021/number-3-september-2021/tango-belt-a-new-smart-hip-protector-solution/

Tango Belt: A New Smart Hip Protector Solution | OJIN ... Tango Belt, a wearable belt that sends real-time data to a smart app and utilizes airbag technology to mitigate fall related hip injuries.