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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
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 moreAwards & 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
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.
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Who is running the clinical trial?
ActiveProtective Technologies, IncLead Sponsor
AvaniaIndustry Sponsor
51 Previous Clinical Trials
9,347 Total Patients Enrolled
Richard Stefanacci, DO, MGH,MBA, AGSF, CMDPrincipal InvestigatorActiveProtective Technologies, Inc
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are 64 years old or younger.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.Your waist measurement is between 29 and 50 inches (63.5 - 127 cm).You need help from someone else to move from one place to another or to walk.You are 65 years old or older.You have broken a bone from a fall after age 50, or you have had one or more falls in the year before joining the study and have been diagnosed with osteoporosis, osteopenia, or are taking medication for osteoporosis.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention Group
- Group 2: Control Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Fall Injury Patient Testimony for trial: Trial Name: NCT05245097 — N/A
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