Trial Outcomes & Findings for Real-time Location System Feasibility Study (NCT NCT03988751)
NCT ID: NCT03988751
Last Updated: 2024-02-22
Results Overview
Characterize number of participants who tolerate continuous vs interval 40m walk by evaluation of adverse events and change in vital signs.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
22 participants
Primary outcome timeframe
1 day
Results posted on
2024-02-22
Participant Flow
Participant milestones
| Measure |
Continuous Ambulation
The total distance will be 40 meters. Study team members will walk, support, and coach the subject to walk as slow as he/she wants. Ambulation speed and duration per patient.
|
Interval Ambulation
The subject will walk a total distance of 40 meters. This distance will be divided into four intervals of 10 meters to equal the same measured distance as the continuous group. The subject will receive two minutes of rest between each interval and will be supported and coached to walk as fast as they can.
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
11
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Continuous Ambulation
The total distance will be 40 meters. Study team members will walk, support, and coach the subject to walk as slow as he/she wants. Ambulation speed and duration per patient.
|
Interval Ambulation
The subject will walk a total distance of 40 meters. This distance will be divided into four intervals of 10 meters to equal the same measured distance as the continuous group. The subject will receive two minutes of rest between each interval and will be supported and coached to walk as fast as they can.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
Baseline Characteristics
Real-time Location System Feasibility Study
Baseline characteristics by cohort
| Measure |
Continuous Ambulation
n=10 Participants
The subject will walk a total distance of 40 meters. Study team members will walk, support, and coach the subject to walk as slow as he/she wants.
|
Interval Ambulation
n=10 Participants
The subject will walk a total distance of 40 meters. This distance will be divided into four intervals of 10 meters to equal the same measured distance as the continuous group. The subject will receive two minutes of rest between each interval and will be supported and coached to walk as fast as they can.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Age, Continuous
|
65 years
n=93 Participants
|
64 years
n=4 Participants
|
64 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=93 Participants
|
10 participants
n=4 Participants
|
10 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 1 dayPopulation: Number of participants who completed 40 meter ambulation without adverse event or significant change in vital signs
Characterize number of participants who tolerate continuous vs interval 40m walk by evaluation of adverse events and change in vital signs.
Outcome measures
| Measure |
Continuous Ambulation
n=10 Participants
The total distance will be 40 meters. Study team members will walk, support, and coach the subject to walk as slow as he/she wants. Ambulation speed and duration per patient.
|
Interval Ambulation
n=10 Participants
The subject will walk a total distance of 40 meters. This distance will be divided into four intervals of 10 meters to equal the same measured distance as the continuous group. The subject will receive two minutes of rest between each interval and will be supported and coached to walk as fast as they can.
|
|---|---|---|
|
Characterize Number of Participants Who Tolerate Continuous vs Interval 40m Walk.
|
10 Participants
|
10 Participants
|
Adverse Events
Continuous Ambulation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Interval Ambulation
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
Dr. Clancy Clark
Wake Forest University School of Medicine
Phone: 335-480-8064
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place