Tango Belt for Hip Injury Due to Falls

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

134 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

How does the Tango Belt treatment differ from other treatments for hip injuries due to falls?

The Tango Belt is unique because it is a wearable device designed to prevent hip injuries from falls, unlike traditional treatments that focus on rehabilitation after an injury has occurred. This proactive approach aims to reduce the incidence of hip injuries by providing protection during a fall, rather than treating the injury after it happens. ^{1 2 3 4 5}

Research Team

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

Principal Investigator

ActiveProtective Technologies, Inc

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Injuries presenting to a walk-in clinic at a summer dance intensive program: a three-year retrospective data analysis. [2014]

2. United States pubmed.ncbi.nlm.nih.gov

Radiographic Evidence of Hip Microinstability in Elite Ballet. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Injuries in Irish dance. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Ballet injuries. An analysis of epidemiology and financial outcome. [2017]

5. United States pubmed.ncbi.nlm.nih.gov

A new consideration in athletic injuries. The classical ballet dancer. [2019]