Trial Outcomes & Findings for Sensors Prediction Study (NCT NCT04541992)
NCT ID: NCT04541992
Last Updated: 2026-04-29
Results Overview
Region of Limb Stability (ROLS) measured in cm\^2 using a body-worn sensor.
Recruitment status
COMPLETED
Target enrollment
1891 participants
Primary outcome timeframe
Day 1
Results posted on
2026-04-29
Participant Flow
WOMACK Recruitment and electronic medical record follow-up
Participant milestones
| Measure |
ROLS & TADS Group
Measures of single limb stability and agility
|
|---|---|
|
Overall Study
STARTED
|
1891
|
|
Overall Study
COMPLETED
|
1891
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
ROLS/TADS Group
n=1891 Participants
Measures of single limb stability / Measures of dynamic stability
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=1891 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1891 Participants
n=1891 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=1891 Participants
|
|
Sex: Female, Male
Female
|
148 Participants
n=1891 Participants
|
|
Sex: Female, Male
Male
|
1743 Participants
n=1891 Participants
|
PRIMARY outcome
Timeframe: Day 1Region of Limb Stability (ROLS) measured in cm\^2 using a body-worn sensor.
Outcome measures
| Measure |
Airborne Group
n=1891 Participants
Participants in this group will be tested for balance and agility within a 20 minute time frame.
|
|---|---|
|
Region of Limb Stability
|
68.16 cm2
Standard Deviation 25.96
|
PRIMARY outcome
Timeframe: Day 1Transitional Angular Displacement of Segments (TADS) measured in degrees per second using a body-worn sensor.
Outcome measures
| Measure |
Airborne Group
n=1891 Participants
Participants in this group will be tested for balance and agility within a 20 minute time frame.
|
|---|---|
|
Transitional Angular Displacement of Segments
|
81.78 deg/sec
Standard Deviation 11.9
|
Adverse Events
ROLS & TADS Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Robert Gailey
University of Miami Miller School of Medicine
Phone: 3052844535
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place