Trial Outcomes & Findings for Mitigation of Major Hip Injury Due to Fall With a Smart Belt (NCT NCT05245097)
NCT ID: NCT05245097
Last Updated: 2025-06-13
Results Overview
The percent of subjects in the ITT population with major hip injuries due to serious hip-impacting falls.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
471 participants
Primary outcome timeframe
6 months
Results posted on
2025-06-13
Participant Flow
The intervention group was recruited via clinical site health record review for the inclusion/exclusion criteria available and waist circumference obtained by sub-investigator on-site and offered informed consent. The control group was determined via historical clinical site health record review determining subject eligibility based on inclusion/exclusion criteria except waist circumference and did not need consent.
Intervention subjects initially enrolled (207) attempted a 14-day run-in period during which adherence to use of the study device was measured. 73 subjects who do not meet the run-in period requirement (64% adherence to wear) were withdrawn from the study resulting in 134 fully enrolled intervention group subjects.
Participant milestones
| Measure |
Intervention Group
134 patients were fully enrolled into the intervention group after achieving the minimum run-in adherence with the withdrawal of 73 patients prior to achieving or failing Run-In.
|
Control Group
264 retrospective control subjects were matched to the fully enrolled intervention group of 134.
|
|---|---|---|
|
Overall Study
STARTED
|
134
|
264
|
|
Overall Study
COMPLETED
|
79
|
246
|
|
Overall Study
NOT COMPLETED
|
55
|
18
|
Reasons for withdrawal
| Measure |
Intervention Group
134 patients were fully enrolled into the intervention group after achieving the minimum run-in adherence with the withdrawal of 73 patients prior to achieving or failing Run-In.
|
Control Group
264 retrospective control subjects were matched to the fully enrolled intervention group of 134.
|
|---|---|---|
|
Overall Study
Adverse Event
|
13
|
2
|
|
Overall Study
Protocol Violation
|
8
|
6
|
|
Overall Study
Withdrawal by Subject
|
18
|
0
|
|
Overall Study
Death
|
6
|
7
|
|
Overall Study
Physician Decision
|
6
|
0
|
|
Overall Study
Relocation
|
4
|
3
|
Baseline Characteristics
Mitigation of Major Hip Injury Due to Fall With a Smart Belt
Baseline characteristics by cohort
| Measure |
Intervention Group
n=134 Participants
The intervention group subjects meeting the requirements of the inclusion and exclusion criteria and who consented to study enrollment, received Standard of Care (SOC) for managing fall risk as per the CDC's Stopping Elderly Accidents, Deaths, and Injuries (STEADI) initiative and were 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.
|
Control Group
n=264 Participants
Control group subjects meeting the requirements of the inclusion and exclusion criteria (except for the waist circumference and need for consent) were identified via clinical site health records and received the standard of care (SOC) for managing fall risk as per the CDC's Stopping Elderly Accidents, Deaths, and Injuries (STEADI) initiative. Their falls and fall injuries were recorded for the 6 months following their retrospective enrollment date.
|
Total
n=398 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
87.3 years
STANDARD_DEVIATION 7.15 • n=99 Participants
|
87.5 years
STANDARD_DEVIATION 6.40 • n=107 Participants
|
87.5 years
STANDARD_DEVIATION 6.7 • n=206 Participants
|
|
Sex: Female, Male
Female
|
102 Participants
n=99 Participants
|
209 Participants
n=107 Participants
|
311 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=99 Participants
|
55 Participants
n=107 Participants
|
87 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaskan Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
129 Participants
n=99 Participants
|
257 Participants
n=107 Participants
|
386 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
134 participants
n=99 Participants
|
264 participants
n=107 Participants
|
398 participants
n=206 Participants
|
|
Highest Mobility Level
Independent
|
75 Participants
n=99 Participants
|
149 Participants
n=107 Participants
|
224 Participants
n=206 Participants
|
|
Highest Mobility Level
Supervision
|
24 Participants
n=99 Participants
|
44 Participants
n=107 Participants
|
68 Participants
n=206 Participants
|
|
Highest Mobility Level
Limited Assist
|
34 Participants
n=99 Participants
|
70 Participants
n=107 Participants
|
104 Participants
n=206 Participants
|
|
Highest Mobility Level
Extensive Assist
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Highest Mobility Level
Total Dependence
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Fall Risk Factor
|
125 Participants
n=99 Participants
|
249 Participants
n=107 Participants
|
374 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: The analysis population consists of all intervention population subjects who demonstrated at least 64% adherence to use of device during run-in period and the propensity matched historical controls.
The percent of subjects in the ITT population with major hip injuries due to serious hip-impacting falls.
Outcome measures
| Measure |
Intervention Group
n=134 Participants
The intervention group was 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 and received Standard of Care (SOC) for managing the fall risk of geriatric patients is the CDC's Stopping Elderly Accidents, Deaths, and Injuries (STEADI) initiative, which implements the America and British Geriatric Societies'' Clinical Practice Guidelines for fall risk management.
|
Control Group
n=264 Participants
The control group received Standard of Care (SOC) for managing the fall risk of geriatric patients is the CDC's Stopping Elderly Accidents, Deaths, and Injuries (STEADI) initiative, which implements the America and British Geriatric Societies'' Clinical Practice Guidelines for fall risk management. Data points on falls and fall injuries were gathered via review of subject health records for their 6 month in-study time.
|
|---|---|---|
|
Major Hip Injuries Due to Serious Hip-impacting Fall
|
1.1 percentage of participants
Interval 0.0 to 3.39
|
12.1 percentage of participants
Interval 8.44 to 16.68
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: The analysis population consisted of all intervention population subjects who demonstrate at least 64% adherence to use of device during run-in period (defined as wearing device for at least 1 hour per day for at least 9 of 14 days) and the propensity matched historical controls.
The number of subjects in the ITT group with hip fractures related to a fall event.
Outcome measures
| Measure |
Intervention Group
n=134 Participants
The intervention group was 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 and received Standard of Care (SOC) for managing the fall risk of geriatric patients is the CDC's Stopping Elderly Accidents, Deaths, and Injuries (STEADI) initiative, which implements the America and British Geriatric Societies'' Clinical Practice Guidelines for fall risk management.
|
Control Group
n=264 Participants
The control group received Standard of Care (SOC) for managing the fall risk of geriatric patients is the CDC's Stopping Elderly Accidents, Deaths, and Injuries (STEADI) initiative, which implements the America and British Geriatric Societies'' Clinical Practice Guidelines for fall risk management. Data points on falls and fall injuries were gathered via review of subject health records for their 6 month in-study time.
|
|---|---|---|
|
Number of Hip Fractures Related to Fall
|
3 participants
Interval 1.0 to 9.0
|
30 participants
Interval 21.0 to 42.0
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: The analysis population consisted of all intervention population subjects who demonstrate at least 64% adherence to use of device during run-in period (defined as wearing device for at least 1 hour per day for at least 9 of 14 days) and the propensity matched historical controls.
The number of subjects in the ITT group with emergency department visits related to fall.
Outcome measures
| Measure |
Intervention Group
n=134 Participants
The intervention group was 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 and received Standard of Care (SOC) for managing the fall risk of geriatric patients is the CDC's Stopping Elderly Accidents, Deaths, and Injuries (STEADI) initiative, which implements the America and British Geriatric Societies'' Clinical Practice Guidelines for fall risk management.
|
Control Group
n=264 Participants
The control group received Standard of Care (SOC) for managing the fall risk of geriatric patients is the CDC's Stopping Elderly Accidents, Deaths, and Injuries (STEADI) initiative, which implements the America and British Geriatric Societies'' Clinical Practice Guidelines for fall risk management. Data points on falls and fall injuries were gathered via review of subject health records for their 6 month in-study time.
|
|---|---|---|
|
Number of Emergency Department Visits Related to Fall
|
8 participants
Interval 3.0 to 15.0
|
47 participants
Interval 36.0 to 60.0
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: The analysis population consisted of all intervention population subjects who demonstrate at least 64% adherence to use of device during run-in period (defined as wearing device for at least 1 hour per day for at least 9 of 14 days) and the propensity matched historical controls.
The number of subjects in the ITT group admitted to a hospital due to fall.
Outcome measures
| Measure |
Intervention Group
n=134 Participants
The intervention group was 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 and received Standard of Care (SOC) for managing the fall risk of geriatric patients is the CDC's Stopping Elderly Accidents, Deaths, and Injuries (STEADI) initiative, which implements the America and British Geriatric Societies'' Clinical Practice Guidelines for fall risk management.
|
Control Group
n=264 Participants
The control group received Standard of Care (SOC) for managing the fall risk of geriatric patients is the CDC's Stopping Elderly Accidents, Deaths, and Injuries (STEADI) initiative, which implements the America and British Geriatric Societies'' Clinical Practice Guidelines for fall risk management. Data points on falls and fall injuries were gathered via review of subject health records for their 6 month in-study time.
|
|---|---|---|
|
Number of Hospitalizations Due to Fall
|
11 participants
Interval 6.0 to 19.0
|
50 participants
Interval 38.0 to 64.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsPopulation: The safety population includes all subjects who were assigned a Tango Belt and attempted the run-in period.
An Adverse Event is any untoward medical occurrences in a patient or subject receiving an investigational medical device and does not necessarily have to have a causal relationship with the device under investigation. An AE can therefore be any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical device whether or not considered related to the medical device. Any fall event is considered an AE for this study. A Severe Adverse Event is any AE that results in death, is life-threatening, requires in-patient hospitalization or prolongation of existing hospitalization or results in persistent or significant disability/ incapacity.
Outcome measures
| Measure |
Intervention Group
n=207 Participants
The intervention group was 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 and received Standard of Care (SOC) for managing the fall risk of geriatric patients is the CDC's Stopping Elderly Accidents, Deaths, and Injuries (STEADI) initiative, which implements the America and British Geriatric Societies'' Clinical Practice Guidelines for fall risk management.
|
Control Group
n=264 Participants
The control group received Standard of Care (SOC) for managing the fall risk of geriatric patients is the CDC's Stopping Elderly Accidents, Deaths, and Injuries (STEADI) initiative, which implements the America and British Geriatric Societies'' Clinical Practice Guidelines for fall risk management. Data points on falls and fall injuries were gathered via review of subject health records for their 6 month in-study time.
|
|---|---|---|
|
Number and Severity of Adverse Events
Mild Severity Adverse event
|
163 Number of events
|
232 Number of events
|
|
Number and Severity of Adverse Events
Moderate Severity Adverse Event
|
29 Number of events
|
70 Number of events
|
|
Number and Severity of Adverse Events
Severe Severity Adverse Event
|
27 Number of events
|
66 Number of events
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsThe number of major injuries that were due to a fall.
Outcome measures
| Measure |
Intervention Group
n=134 Participants
The intervention group was 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 and received Standard of Care (SOC) for managing the fall risk of geriatric patients is the CDC's Stopping Elderly Accidents, Deaths, and Injuries (STEADI) initiative, which implements the America and British Geriatric Societies'' Clinical Practice Guidelines for fall risk management.
|
Control Group
n=264 Participants
The control group received Standard of Care (SOC) for managing the fall risk of geriatric patients is the CDC's Stopping Elderly Accidents, Deaths, and Injuries (STEADI) initiative, which implements the America and British Geriatric Societies'' Clinical Practice Guidelines for fall risk management. Data points on falls and fall injuries were gathered via review of subject health records for their 6 month in-study time.
|
|---|---|---|
|
Number of Major Injuries Due to Fall
|
7 Major injuries due to fall
|
67 Major injuries due to fall
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsPopulation: The fall rate ratio was compared between treatment groups using a Poisson regression model. Treatment was the independent variable and the log of total 180-day durations was the offset variable. The p-value corresponds to the beta coefficient on the treatment variable. A two-sided 0.05 level of significance was used.
The fall rate for the intervention and the control group
Outcome measures
| Measure |
Intervention Group
n=134 Participants
The intervention group was 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 and received Standard of Care (SOC) for managing the fall risk of geriatric patients is the CDC's Stopping Elderly Accidents, Deaths, and Injuries (STEADI) initiative, which implements the America and British Geriatric Societies'' Clinical Practice Guidelines for fall risk management.
|
Control Group
n=264 Participants
The control group received Standard of Care (SOC) for managing the fall risk of geriatric patients is the CDC's Stopping Elderly Accidents, Deaths, and Injuries (STEADI) initiative, which implements the America and British Geriatric Societies'' Clinical Practice Guidelines for fall risk management. Data points on falls and fall injuries were gathered via review of subject health records for their 6 month in-study time.
|
|---|---|---|
|
Rate of Fall Occurence
|
1.56 Falls per 180-day duration
|
1.31 Falls per 180-day duration
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 90 days and 180 daysPopulation: The study device was not offered to the control group and so device adherence was only measured for the intervention group.
Adherence to wearing of the study device in days/month
Outcome measures
| Measure |
Intervention Group
n=134 Participants
The intervention group was 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 and received Standard of Care (SOC) for managing the fall risk of geriatric patients is the CDC's Stopping Elderly Accidents, Deaths, and Injuries (STEADI) initiative, which implements the America and British Geriatric Societies'' Clinical Practice Guidelines for fall risk management.
|
Control Group
The control group received Standard of Care (SOC) for managing the fall risk of geriatric patients is the CDC's Stopping Elderly Accidents, Deaths, and Injuries (STEADI) initiative, which implements the America and British Geriatric Societies'' Clinical Practice Guidelines for fall risk management. Data points on falls and fall injuries were gathered via review of subject health records for their 6 month in-study time.
|
|---|---|---|
|
Device Wear Adherence
90 day
|
21.9 Tango Belt wear in Days/month
Standard Deviation 6.08
|
—
|
|
Device Wear Adherence
180 day
|
20.1 Tango Belt wear in Days/month
Standard Deviation 6.71
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsCompliance to wearing of the study device in hours/day average
Outcome measures
| Measure |
Intervention Group
n=134 Participants
The intervention group was 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 and received Standard of Care (SOC) for managing the fall risk of geriatric patients is the CDC's Stopping Elderly Accidents, Deaths, and Injuries (STEADI) initiative, which implements the America and British Geriatric Societies'' Clinical Practice Guidelines for fall risk management.
|
Control Group
The control group received Standard of Care (SOC) for managing the fall risk of geriatric patients is the CDC's Stopping Elderly Accidents, Deaths, and Injuries (STEADI) initiative, which implements the America and British Geriatric Societies'' Clinical Practice Guidelines for fall risk management. Data points on falls and fall injuries were gathered via review of subject health records for their 6 month in-study time.
|
|---|---|---|
|
Device Wear Compliance
|
5.9 hours/day in-study time
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsRate of airbag deployments that occurred while an intervention subject was not experiencing a serious hip-impacting fall.
Outcome measures
| Measure |
Intervention Group
n=207 Participants
The intervention group was 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 and received Standard of Care (SOC) for managing the fall risk of geriatric patients is the CDC's Stopping Elderly Accidents, Deaths, and Injuries (STEADI) initiative, which implements the America and British Geriatric Societies'' Clinical Practice Guidelines for fall risk management.
|
Control Group
The control group received Standard of Care (SOC) for managing the fall risk of geriatric patients is the CDC's Stopping Elderly Accidents, Deaths, and Injuries (STEADI) initiative, which implements the America and British Geriatric Societies'' Clinical Practice Guidelines for fall risk management. Data points on falls and fall injuries were gathered via review of subject health records for their 6 month in-study time.
|
|---|---|---|
|
Accuracy of Device Fall Discrimination
|
1.59 false positives per 1000 person-days
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsPopulation: The adherence population includes all subjects in the PP population excluding those subjects who were not actually wearing Tango Belt when the primary effectiveness endpoint was experienced.
Accuracy of the study device airbag deployment as designed is demonstrated in the number of hip fractures that occurred by intervention subjects wearing the device during serious hip-impacting falls.
Outcome measures
| Measure |
Intervention Group
n=132 Participants
The intervention group was 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 and received Standard of Care (SOC) for managing the fall risk of geriatric patients is the CDC's Stopping Elderly Accidents, Deaths, and Injuries (STEADI) initiative, which implements the America and British Geriatric Societies'' Clinical Practice Guidelines for fall risk management.
|
Control Group
The control group received Standard of Care (SOC) for managing the fall risk of geriatric patients is the CDC's Stopping Elderly Accidents, Deaths, and Injuries (STEADI) initiative, which implements the America and British Geriatric Societies'' Clinical Practice Guidelines for fall risk management. Data points on falls and fall injuries were gathered via review of subject health records for their 6 month in-study time.
|
|---|---|---|
|
Accuracy of Study Device Airbag Deployment
|
0 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsPopulation: The number of intervention subjects changed as the study time line proceeded and some intervention subjects exited prior to the 90 day and 180 day.
Short version of the Falls Efficacy Scale International (where applicable for those deemed able to take the questionnaire (BIMS of 13-15)) to offer level of balance confidence as defined by the scale (range from 7 (no concern about falling) to 28 (severe concern about falling).
Outcome measures
| Measure |
Intervention Group
n=134 Participants
The intervention group was 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 and received Standard of Care (SOC) for managing the fall risk of geriatric patients is the CDC's Stopping Elderly Accidents, Deaths, and Injuries (STEADI) initiative, which implements the America and British Geriatric Societies'' Clinical Practice Guidelines for fall risk management.
|
Control Group
The control group received Standard of Care (SOC) for managing the fall risk of geriatric patients is the CDC's Stopping Elderly Accidents, Deaths, and Injuries (STEADI) initiative, which implements the America and British Geriatric Societies'' Clinical Practice Guidelines for fall risk management. Data points on falls and fall injuries were gathered via review of subject health records for their 6 month in-study time.
|
|---|---|---|
|
Balance Confidence Score Changes
Baseline
|
15.3 FES-I Short Version Score
Standard Deviation 4.29
|
—
|
|
Balance Confidence Score Changes
90 day
|
15.4 FES-I Short Version Score
Standard Deviation 4.16
|
—
|
|
Balance Confidence Score Changes
180 day
|
14.7 FES-I Short Version Score
Standard Deviation 4.68
|
—
|
Adverse Events
Safety Population
Serious events: 33 serious events
Other events: 67 other events
Deaths: 6 deaths
Control Group
Serious events: 66 serious events
Other events: 152 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Safety Population
n=207 participants at risk
The Safety Population includes all intervention subjects that were offered the study device and entered into the run-in period (207) prior to full study enrollment after passing the adherence metric (134). This group was 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 and received Standard of Care (SOC) for managing the fall risk of geriatric patients is the CDC's Stopping Elderly Accidents, Deaths, and Injuries (STEADI) initiative, which implements the America and British Geriatric Societies'' Clinical Practice Guidelines for fall risk management.
|
Control Group
n=264 participants at risk
The control group received Standard of Care (SOC) for managing the fall risk of geriatric patients is the CDC's Stopping Elderly Accidents, Deaths, and Injuries (STEADI) initiative, which implements the America and British Geriatric Societies'' Clinical Practice Guidelines for fall risk management. Data points on falls and fall injuries were gathered via review of subject health records for their 6 month in-study time.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Fall with Fracture
|
2.9%
6/207 • Number of events 6 • Adverse events were recorded for all study subjects within their respective 6 month in-study timeframe.
An Adverse Event (AE) is any untoward medical occurrences in a patient or subject receiving an investigational medical device and does not necessarily have to have a causal relationship with the device under investigation. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medical device whether or not considered related to the medical device. Any fall event is considered an AE for this study. Severity assessed by investigator.
|
21.6%
57/264 • Number of events 59 • Adverse events were recorded for all study subjects within their respective 6 month in-study timeframe.
An Adverse Event (AE) is any untoward medical occurrences in a patient or subject receiving an investigational medical device and does not necessarily have to have a causal relationship with the device under investigation. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medical device whether or not considered related to the medical device. Any fall event is considered an AE for this study. Severity assessed by investigator.
|
|
Infections and infestations
Infection
|
1.9%
4/207 • Number of events 4 • Adverse events were recorded for all study subjects within their respective 6 month in-study timeframe.
An Adverse Event (AE) is any untoward medical occurrences in a patient or subject receiving an investigational medical device and does not necessarily have to have a causal relationship with the device under investigation. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medical device whether or not considered related to the medical device. Any fall event is considered an AE for this study. Severity assessed by investigator.
|
0.38%
1/264 • Number of events 1 • Adverse events were recorded for all study subjects within their respective 6 month in-study timeframe.
An Adverse Event (AE) is any untoward medical occurrences in a patient or subject receiving an investigational medical device and does not necessarily have to have a causal relationship with the device under investigation. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medical device whether or not considered related to the medical device. Any fall event is considered an AE for this study. Severity assessed by investigator.
|
|
Musculoskeletal and connective tissue disorders
Dislocation
|
0.00%
0/207 • Adverse events were recorded for all study subjects within their respective 6 month in-study timeframe.
An Adverse Event (AE) is any untoward medical occurrences in a patient or subject receiving an investigational medical device and does not necessarily have to have a causal relationship with the device under investigation. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medical device whether or not considered related to the medical device. Any fall event is considered an AE for this study. Severity assessed by investigator.
|
0.38%
1/264 • Number of events 1 • Adverse events were recorded for all study subjects within their respective 6 month in-study timeframe.
An Adverse Event (AE) is any untoward medical occurrences in a patient or subject receiving an investigational medical device and does not necessarily have to have a causal relationship with the device under investigation. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medical device whether or not considered related to the medical device. Any fall event is considered an AE for this study. Severity assessed by investigator.
|
|
General disorders
Other
|
11.1%
23/207 • Number of events 23 • Adverse events were recorded for all study subjects within their respective 6 month in-study timeframe.
An Adverse Event (AE) is any untoward medical occurrences in a patient or subject receiving an investigational medical device and does not necessarily have to have a causal relationship with the device under investigation. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medical device whether or not considered related to the medical device. Any fall event is considered an AE for this study. Severity assessed by investigator.
|
2.7%
7/264 • Number of events 7 • Adverse events were recorded for all study subjects within their respective 6 month in-study timeframe.
An Adverse Event (AE) is any untoward medical occurrences in a patient or subject receiving an investigational medical device and does not necessarily have to have a causal relationship with the device under investigation. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medical device whether or not considered related to the medical device. Any fall event is considered an AE for this study. Severity assessed by investigator.
|
Other adverse events
| Measure |
Safety Population
n=207 participants at risk
The Safety Population includes all intervention subjects that were offered the study device and entered into the run-in period (207) prior to full study enrollment after passing the adherence metric (134). This group was 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 and received Standard of Care (SOC) for managing the fall risk of geriatric patients is the CDC's Stopping Elderly Accidents, Deaths, and Injuries (STEADI) initiative, which implements the America and British Geriatric Societies'' Clinical Practice Guidelines for fall risk management.
|
Control Group
n=264 participants at risk
The control group received Standard of Care (SOC) for managing the fall risk of geriatric patients is the CDC's Stopping Elderly Accidents, Deaths, and Injuries (STEADI) initiative, which implements the America and British Geriatric Societies'' Clinical Practice Guidelines for fall risk management. Data points on falls and fall injuries were gathered via review of subject health records for their 6 month in-study time.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Fall Event
|
21.3%
44/207 • Number of events 145 • Adverse events were recorded for all study subjects within their respective 6 month in-study timeframe.
An Adverse Event (AE) is any untoward medical occurrences in a patient or subject receiving an investigational medical device and does not necessarily have to have a causal relationship with the device under investigation. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medical device whether or not considered related to the medical device. Any fall event is considered an AE for this study. Severity assessed by investigator.
|
45.1%
119/264 • Number of events 276 • Adverse events were recorded for all study subjects within their respective 6 month in-study timeframe.
An Adverse Event (AE) is any untoward medical occurrences in a patient or subject receiving an investigational medical device and does not necessarily have to have a causal relationship with the device under investigation. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medical device whether or not considered related to the medical device. Any fall event is considered an AE for this study. Severity assessed by investigator.
|
|
Skin and subcutaneous tissue disorders
Discomfort
|
12.1%
25/207 • Number of events 25 • Adverse events were recorded for all study subjects within their respective 6 month in-study timeframe.
An Adverse Event (AE) is any untoward medical occurrences in a patient or subject receiving an investigational medical device and does not necessarily have to have a causal relationship with the device under investigation. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medical device whether or not considered related to the medical device. Any fall event is considered an AE for this study. Severity assessed by investigator.
|
15.2%
40/264 • Number of events 51 • Adverse events were recorded for all study subjects within their respective 6 month in-study timeframe.
An Adverse Event (AE) is any untoward medical occurrences in a patient or subject receiving an investigational medical device and does not necessarily have to have a causal relationship with the device under investigation. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medical device whether or not considered related to the medical device. Any fall event is considered an AE for this study. Severity assessed by investigator.
|
|
Musculoskeletal and connective tissue disorders
Soreness
|
1.9%
4/207 • Number of events 4 • Adverse events were recorded for all study subjects within their respective 6 month in-study timeframe.
An Adverse Event (AE) is any untoward medical occurrences in a patient or subject receiving an investigational medical device and does not necessarily have to have a causal relationship with the device under investigation. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medical device whether or not considered related to the medical device. Any fall event is considered an AE for this study. Severity assessed by investigator.
|
4.9%
13/264 • Number of events 13 • Adverse events were recorded for all study subjects within their respective 6 month in-study timeframe.
An Adverse Event (AE) is any untoward medical occurrences in a patient or subject receiving an investigational medical device and does not necessarily have to have a causal relationship with the device under investigation. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medical device whether or not considered related to the medical device. Any fall event is considered an AE for this study. Severity assessed by investigator.
|
|
Skin and subcutaneous tissue disorders
abrassion
|
4.3%
9/207 • Number of events 10 • Adverse events were recorded for all study subjects within their respective 6 month in-study timeframe.
An Adverse Event (AE) is any untoward medical occurrences in a patient or subject receiving an investigational medical device and does not necessarily have to have a causal relationship with the device under investigation. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medical device whether or not considered related to the medical device. Any fall event is considered an AE for this study. Severity assessed by investigator.
|
9.5%
25/264 • Number of events 25 • Adverse events were recorded for all study subjects within their respective 6 month in-study timeframe.
An Adverse Event (AE) is any untoward medical occurrences in a patient or subject receiving an investigational medical device and does not necessarily have to have a causal relationship with the device under investigation. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medical device whether or not considered related to the medical device. Any fall event is considered an AE for this study. Severity assessed by investigator.
|
|
Psychiatric disorders
confusion
|
2.9%
6/207 • Number of events 7 • Adverse events were recorded for all study subjects within their respective 6 month in-study timeframe.
An Adverse Event (AE) is any untoward medical occurrences in a patient or subject receiving an investigational medical device and does not necessarily have to have a causal relationship with the device under investigation. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medical device whether or not considered related to the medical device. Any fall event is considered an AE for this study. Severity assessed by investigator.
|
5.3%
14/264 • Number of events 18 • Adverse events were recorded for all study subjects within their respective 6 month in-study timeframe.
An Adverse Event (AE) is any untoward medical occurrences in a patient or subject receiving an investigational medical device and does not necessarily have to have a causal relationship with the device under investigation. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medical device whether or not considered related to the medical device. Any fall event is considered an AE for this study. Severity assessed by investigator.
|
|
Skin and subcutaneous tissue disorders
Laceration
|
6.8%
14/207 • Number of events 15 • Adverse events were recorded for all study subjects within their respective 6 month in-study timeframe.
An Adverse Event (AE) is any untoward medical occurrences in a patient or subject receiving an investigational medical device and does not necessarily have to have a causal relationship with the device under investigation. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medical device whether or not considered related to the medical device. Any fall event is considered an AE for this study. Severity assessed by investigator.
|
12.1%
32/264 • Number of events 36 • Adverse events were recorded for all study subjects within their respective 6 month in-study timeframe.
An Adverse Event (AE) is any untoward medical occurrences in a patient or subject receiving an investigational medical device and does not necessarily have to have a causal relationship with the device under investigation. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medical device whether or not considered related to the medical device. Any fall event is considered an AE for this study. Severity assessed by investigator.
|
|
General disorders
Other
|
11.6%
24/207 • Number of events 39 • Adverse events were recorded for all study subjects within their respective 6 month in-study timeframe.
An Adverse Event (AE) is any untoward medical occurrences in a patient or subject receiving an investigational medical device and does not necessarily have to have a causal relationship with the device under investigation. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medical device whether or not considered related to the medical device. Any fall event is considered an AE for this study. Severity assessed by investigator.
|
9.5%
25/264 • Number of events 29 • Adverse events were recorded for all study subjects within their respective 6 month in-study timeframe.
An Adverse Event (AE) is any untoward medical occurrences in a patient or subject receiving an investigational medical device and does not necessarily have to have a causal relationship with the device under investigation. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medical device whether or not considered related to the medical device. Any fall event is considered an AE for this study. Severity assessed by investigator.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60