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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
Have a waist circumference between 29 - 50 inches (63.5 - 127 cm)
Age 65 years or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Study Summary

This trial is a study to see if the Tango Belt is safe and effective. The belt must be worn for at least 6 months, except during bathing, charging, and as deemed by clinical staff. There will be primary and secondary endpoints taken every 3 months and at the end of the study.

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.Check my eligibility
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.See study design
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
Your waist measurement is between 29 and 50 inches (63.5 - 127 cm).
Select...
You are 65 years old or older.
Select...
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Major hip injuries due to fall
Secondary outcome measures
Accidental Falls
Number of hip fractures due to fall
Number of hospitalizations due to fall
Other outcome measures
Accuracy of device fall discrimination
Accuracy of study device airbag deployment
Balance confidence score changes
+5 more

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

Find a Location

Who is running the clinical trial?

ActiveProtective Technologies, IncLead Sponsor
AvaniaIndustry Sponsor
41 Previous Clinical Trials
8,440 Total Patients Enrolled
Richard Stefanacci, DO, MGH,MBA, AGSF, CMDPrincipal InvestigatorActiveProtective Technologies, Inc

Media Library

Tango Belt (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05245097 — N/A
Fall Injury Research Study Groups: Control Group, Intervention Group
Fall Injury Clinical Trial 2023: Tango Belt Highlights & Side Effects. Trial Name: NCT05245097 — N/A
Tango Belt (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05245097 — N/A
Fall Injury Patient Testimony for trial: Trial Name: NCT05245097 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there numerous medical centers conducting this research trial in the region?

"Currently, there are 7 facilities offering this trial; these include Foulkeways at Gwynedd located in Gwynedd, Chandler Hall Health Services situated in Newtown and Meadowood Senior Living based in Lansdale."

Answered by AI

Can new participants join this experiment currently?

"Indeed, clinicaltrials.gov shows that this medical experiment has been open for recruitment since March 29th 2022 and was modified on December 1st of the same year."

Answered by AI

Could you provide an estimate of the total participants in this clinical research project?

"Affirmative. Clinicaltrials.gov's records demonstrate that, starting from March 29th 2022 and most recently updated on December 1st 2022, this trial is presently seeking participants. As such, the study requires 500 people to be recruited across 7 locations."

Answered by AI

Who else is applying?

What state do they live in?
Arizona
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

would like to be part of a study adding to our body of knowledge about osteoporosis prevention.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

Recent research and studies
~45 spots leftby Mar 2025