Trial Outcomes & Findings for Outcomes of Compliance With Brace Wear in Clubfoot (NCT NCT01481324)
NCT ID: NCT01481324
Last Updated: 2014-11-24
Results Overview
Number of hours per day in brace will be measured by pressure sensor at the end of month 1, month 2 and month 3. Parent report of brace wear will also be documented at each of these timepoints. Wear rate percentage will be calculated by dividing the number of hours of brace wear (either actual as measured by the sensor or reported by parent diary) by the recommended 24 hours.
Recruitment status
COMPLETED
Target enrollment
67 participants
Primary outcome timeframe
3 months
Results posted on
2014-11-24
Participant Flow
Participant milestones
| Measure |
Functioning Pressure Sensor Group
This group will have a functioning pressure sensor placed on the foot ankle orthosis. The group will be blinded as to whether or not the sensor is functioning.
|
Non-Functioning Pressure Sensor Group
This group will have a non-functioning pressure sensor (a placebo) placed on the foot ankle orthosis. The group will be blinded as to whether or not the sensor is functioning.
|
No Sensor Group
This group will not have a pressure sensor placed on the foot ankle orthosis.
|
|---|---|---|---|
|
Overall Study
STARTED
|
21
|
24
|
22
|
|
Overall Study
Month 1-Wear Rate Data
|
15
|
16
|
8
|
|
Overall Study
Month 2-Wear Rate Data
|
9
|
13
|
7
|
|
Overall Study
Month 3-Wear Rate Data
|
7
|
11
|
6
|
|
Overall Study
COMPLETED
|
21
|
22
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
2
|
Reasons for withdrawal
| Measure |
Functioning Pressure Sensor Group
This group will have a functioning pressure sensor placed on the foot ankle orthosis. The group will be blinded as to whether or not the sensor is functioning.
|
Non-Functioning Pressure Sensor Group
This group will have a non-functioning pressure sensor (a placebo) placed on the foot ankle orthosis. The group will be blinded as to whether or not the sensor is functioning.
|
No Sensor Group
This group will not have a pressure sensor placed on the foot ankle orthosis.
|
|---|---|---|---|
|
Overall Study
Missing Data
|
0
|
2
|
2
|
Baseline Characteristics
Outcomes of Compliance With Brace Wear in Clubfoot
Baseline characteristics by cohort
| Measure |
Functioning Pressure Sensor Group
n=21 Participants
This group will have a functioning pressure sensor placed on the foot ankle orthosis. The group will be blinded as to whether or not the sensor is functioning.
|
Non-Functioning Pressure Sensor Group
n=22 Participants
This group will have a non-functioning pressure sensor (a placebo) placed on the foot ankle orthosis. The group will be blinded as to whether or not the sensor is functioning.
|
No Sensor Group
n=20 Participants
This group will not have a pressure sensor placed on the foot ankle orthosis.
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
21 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
63 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 3 monthsNumber of hours per day in brace will be measured by pressure sensor at the end of month 1, month 2 and month 3. Parent report of brace wear will also be documented at each of these timepoints. Wear rate percentage will be calculated by dividing the number of hours of brace wear (either actual as measured by the sensor or reported by parent diary) by the recommended 24 hours.
Outcome measures
| Measure |
Functioning Pressure Sensor Group
n=21 Participants
This group will have a functioning pressure sensor placed on the foot ankle orthosis. The group will be blinded as to whether or not the sensor is functioning.
|
Non-Functioning Pressure Sensor Group
n=22 Participants
This group will have a non-functioning pressure sensor (a placebo) placed on the foot ankle orthosis. The group will be blinded as to whether or not the sensor is functioning.
|
No Sensor Group
n=20 Participants
This group will not have a pressure sensor placed on the foot ankle orthosis.
|
|---|---|---|---|
|
Wear Rate Percentage (Number of Hours Per Day Brace Was Worn Out of the Recommended 24 Hours)
Month 1 Actual Wear Rate
|
91.7 percentage of time worn
Interval 72.7 to 97.0
|
NA percentage of time worn
No sensor data available
|
NA percentage of time worn
No sensor data available
|
|
Wear Rate Percentage (Number of Hours Per Day Brace Was Worn Out of the Recommended 24 Hours)
Month 2 Actual Wear Rate
|
86.8 percentage of time worn
Interval 60.5 to 96.3
|
NA percentage of time worn
No sensor data available
|
NA percentage of time worn
No sensor data available
|
|
Wear Rate Percentage (Number of Hours Per Day Brace Was Worn Out of the Recommended 24 Hours)
Month 3 Actual Wear Rate
|
77.1 percentage of time worn
Interval 52.6 to 95.8
|
NA percentage of time worn
No sensor data available
|
NA percentage of time worn
No sensor data available
|
|
Wear Rate Percentage (Number of Hours Per Day Brace Was Worn Out of the Recommended 24 Hours)
Month 1 Reported Wear Rate
|
94.9 percentage of time worn
Interval 93.1 to 98.7
|
95.5 percentage of time worn
Interval 91.8 to 98.7
|
94.8 percentage of time worn
Interval 84.3 to 98.8
|
|
Wear Rate Percentage (Number of Hours Per Day Brace Was Worn Out of the Recommended 24 Hours)
Month 2 Reported Wear Rate
|
95.6 percentage of time worn
Interval 92.3 to 99.4
|
95.8 percentage of time worn
Interval 90.6 to 98.0
|
94.9 percentage of time worn
Interval 86.9 to 97.3
|
|
Wear Rate Percentage (Number of Hours Per Day Brace Was Worn Out of the Recommended 24 Hours)
Month 3 Reported Wear Rate
|
94.8 percentage of time worn
Interval 82.8 to 99.6
|
89.4 percentage of time worn
Interval 36.7 to 97.7
|
94.2 percentage of time worn
Interval 89.5 to 97.3
|
Adverse Events
Functioning Pressure Sensor Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-Functioning Pressure Sensor Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No Sensor 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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place