Trial Outcomes & Findings for Improving Mobility in Peripheral Artery Disease Using an Ankle Foot Orthosis (NCT NCT02902211)
NCT ID: NCT02902211
Last Updated: 2024-08-20
Results Overview
Change in Initial claudication and the absolute claudication time from the progressive treadmill test when walking with ankle foot orthoses (AFO)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
After three months of intervention with the ankle foot orthosis.
Results posted on
2024-08-20
Participant Flow
Participants who were enrolled withdrew prior to randomization
Participant milestones
| Measure |
Ankle Foot Orthosis Then Control
Patients will wear an off-the-shelf, carbon composite AFO that is adjusted for them for three months. The patients will be asked to wear the AFO at all times except when they are in bed or showering/bathing. The instructions given to the patients about walking will be to follow the instructions from their doctor regarding risk factor management and exercise.
Ankle foot orthosis: Patients will wear an ankle foot orthosis at all times except when he/she is sleeping or bathing for three months.
|
Control Then Ankle Foot Orthoses
Patients will be asked to follow the instructions from their doctor regarding risk factor management and exercise for three months.
Control/standard of care: Patients will carry out with typical activities suggested by their physician for three months.
|
|---|---|---|
|
First Three Months
STARTED
|
12
|
21
|
|
First Three Months
COMPLETED
|
5
|
18
|
|
First Three Months
NOT COMPLETED
|
7
|
3
|
|
Second Three Months
STARTED
|
5
|
18
|
|
Second Three Months
COMPLETED
|
2
|
13
|
|
Second Three Months
NOT COMPLETED
|
3
|
5
|
Reasons for withdrawal
| Measure |
Ankle Foot Orthosis Then Control
Patients will wear an off-the-shelf, carbon composite AFO that is adjusted for them for three months. The patients will be asked to wear the AFO at all times except when they are in bed or showering/bathing. The instructions given to the patients about walking will be to follow the instructions from their doctor regarding risk factor management and exercise.
Ankle foot orthosis: Patients will wear an ankle foot orthosis at all times except when he/she is sleeping or bathing for three months.
|
Control Then Ankle Foot Orthoses
Patients will be asked to follow the instructions from their doctor regarding risk factor management and exercise for three months.
Control/standard of care: Patients will carry out with typical activities suggested by their physician for three months.
|
|---|---|---|
|
First Three Months
Withdrawal by Subject
|
7
|
3
|
Baseline Characteristics
Improving Mobility in Peripheral Artery Disease Using an Ankle Foot Orthosis
Baseline characteristics by cohort
| Measure |
Ankle Foot Orthosis Then Control
n=12 Participants
Patients will wear an off-the-shelf, carbon composite AFO that is adjusted for them for three months. The patients will be asked to wear the AFO at all times except when they are in bed or showering/bathing. The instructions given to the patients about walking will be to follow the instructions from their doctor regarding risk factor management and exercise.
Ankle foot orthosis: Patients will wear an ankle foot orthosis at all times except when he/she is sleeping or bathing for three months.
|
Control Then Ankle Foot Orthosis
n=21 Participants
Patients will be asked to follow the instructions from their doctor regarding risk factor management and exercise for three months.
Control/standard of care: Patients will carry out with typical activities suggested by their physician for three months.
|
Total
n=33 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Age, Continuous
|
66.5 years
STANDARD_DEVIATION 6.2 • n=99 Participants
|
72.6 years
STANDARD_DEVIATION 6.1 • n=107 Participants
|
70.45 years
STANDARD_DEVIATION 6.8 • n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
12 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Claudication time (walking with AFO-Baseline)
Initial claudication time (AFO)
|
114.08 seconds
STANDARD_DEVIATION 71.91 • n=99 Participants
|
190 seconds
STANDARD_DEVIATION 142.41 • n=107 Participants
|
162.39 seconds
STANDARD_DEVIATION 125.81 • n=206 Participants
|
|
Claudication time (walking with AFO-Baseline)
Absoluteclaudication time (AFO)
|
264.75 seconds
STANDARD_DEVIATION 227.03 • n=99 Participants
|
322.3 seconds
STANDARD_DEVIATION 181.11 • n=107 Participants
|
301.42 seconds
STANDARD_DEVIATION 197.5 • n=206 Participants
|
PRIMARY outcome
Timeframe: After three months of intervention with the ankle foot orthosis.Change in Initial claudication and the absolute claudication time from the progressive treadmill test when walking with ankle foot orthoses (AFO)
Outcome measures
| Measure |
Ankle Foot Orthosis Then Control
n=4 Participants
Patients will wear an off-the-shelf, carbon composite AFO that is adjusted for them for three months. The patients will be asked to wear the AFO at all times except when they are in bed or showering/bathing. The instructions given to the patients about walking will be to follow the instructions from their doctor regarding risk factor management and exercise.
Ankle foot orthosis: Patients will wear an ankle foot orthosis at all times except when he/she is sleeping or bathing for three months.
|
Control Then Ankle Foot Orthosis
n=14 Participants
Patients will be asked to follow the instructions from their doctor regarding risk factor management and exercise for three months.
Control/standard of care: Patients will carry out with typical activities suggested by their physician for three months.
|
|---|---|---|
|
Maximum Walking Time From the Gardner Graded Treadmill Protocol
Change in Absolute walking time (Second Intervention: 3 months)
|
188 Seconds
Standard Deviation 171.7
|
339.9 Seconds
Standard Deviation 171.5
|
|
Maximum Walking Time From the Gardner Graded Treadmill Protocol
Change in Initial walking time (First Intervention: 3 months)
|
117.7 Seconds
Standard Deviation 89.8
|
197.5 Seconds
Standard Deviation 154.5
|
Adverse Events
Ankle Foot Orthosis
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
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