471 Participants Needed

Tango Belt for Hip Injury Due to Falls

Recruiting at 9 trial locations
RJ
Overseen ByREBECCA J TARBERT, PT, DPT
Age: 65+
Sex: Any
Trial Phase: Academic
Sponsor: ActiveProtective Technologies, Inc
Must be taking: Osteoporosis medication
Stay on Your Current MedsYou can continue your current medications while participating
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 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.12345

Who Is on the Research Team?

RS

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.
See 5 more

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
See 3 more

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?
2Treatment groups
Experimental Treatment
Group I: Intervention GroupExperimental Treatment2 Interventions
Group II: Control GroupExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

ActiveProtective Technologies, Inc

Lead Sponsor

Trials
1
Recruited
130+

Avania

Industry Sponsor

Trials
59
Recruited
10,000+

Citations

Injuries presenting to a walk-in clinic at a summer dance intensive program: a three-year retrospective data analysis. [2014]
Radiographic Evidence of Hip Microinstability in Elite Ballet. [2022]
Injuries in Irish dance. [2019]
Ballet injuries. An analysis of epidemiology and financial outcome. [2017]
A new consideration in athletic injuries. The classical ballet dancer. [2019]
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