Trial Outcomes & Findings for Do Rocker Bottom Shoes and Ankle-Foot Orthoses Reduce Pain and Improve Mobility for Ankle Osteoarthritis Patients (NCT NCT03524729)
NCT ID: NCT03524729
Last Updated: 2024-09-19
Results Overview
The daily step count of a participant as measured by a body worn pedometer.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
11 participants
Primary outcome timeframe
Three weeks
Results posted on
2024-09-19
Participant Flow
Participant milestones
| Measure |
Ankle Osteoarthritis Patients: AFO, Then RB, Then C
Ambulatory adult patients (18+) with ankle osteoarthritis. Rocker bottom shoe (RB): Walking shoe with a anterior posterior rocker sole. Ankle foot orthosis (AFO): Dynamic carbon fiber ankle brace. Control (C): Standard walking shoe (control shoe) with no rocker sole.
First Intervention (3 weeks) Washout (1 week) Second Intervention (3 weeks) Washout (1 week) Third Intervention (3 weeks)
|
Healthy Control Subjects
Ambulatory adults (18+) with no known ankle osteoarthritis.
Standard walking shoe: Standard walking shoe (control shoe) with no rocker sole.
|
Ankle Osteoarthritis Patients: C, Then RB, Then AFO
Ambulatory adult patients (18+) with ankle osteoarthritis. Rocker bottom shoe (RB): Walking shoe with a anterior posterior rocker sole. Ankle foot orthosis (AFO): Dynamic carbon fiber ankle brace. Control (C): Standard walking shoe (control shoe) with no rocker sole.
First Intervention (3 weeks) Washout (1 week) Second Intervention (3 weeks) Washout (1 week) Third Intervention (3 weeks)
|
Ankle Osteoarthritis Patients: C, Then AFO, Then RB
Ambulatory adult patients (18+) with ankle osteoarthritis. Rocker bottom shoe (RB): Walking shoe with a anterior posterior rocker sole. Ankle foot orthosis (AFO): Dynamic carbon fiber ankle brace. Control (C): Standard walking shoe (control shoe) with no rocker sole.
First Intervention (3 weeks) Washout (1 week) Second Intervention (3 weeks) Washout (1 week) Third Intervention (3 weeks)
|
Ankle Osteoarthritis Patients: RB, Then C, the AFO
Ambulatory adult patients (18+) with ankle osteoarthritis. Rocker bottom shoe (RB): Walking shoe with a anterior posterior rocker sole. Ankle foot orthosis (AFO): Dynamic carbon fiber ankle brace. Control (C): Standard walking shoe (control shoe) with no rocker sole.
First Intervention (3 weeks) Washout (1 week) Second Intervention (3 weeks) Washout (1 week) Third Intervention (3 weeks)
|
Ankle Osteoarthritis Patients: RB, the AFO, Then C
Ambulatory adult patients (18+) with ankle osteoarthritis. Rocker bottom shoe (RB): Walking shoe with a anterior posterior rocker sole. Ankle foot orthosis (AFO): Dynamic carbon fiber ankle brace. Control (C): Standard walking shoe (control shoe) with no rocker sole.
First Intervention (3 weeks) Washout (1 week) Second Intervention (3 weeks) Washout (1 week) Third Intervention (3 weeks)
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
1
|
2
|
2
|
2
|
2
|
|
Overall Study
COMPLETED
|
2
|
1
|
2
|
1
|
2
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
1
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Do Rocker Bottom Shoes and Ankle-Foot Orthoses Reduce Pain and Improve Mobility for Ankle Osteoarthritis Patients
Baseline characteristics by cohort
| Measure |
Ankle Osteoarthritis Patients
n=10 Participants
Ambulatory adult patients (18+) with ankle osteoarthritis.
Rocker bottom shoe: Walking shoe with a anterior posterior rocker sole.
Ankle foot orthosis: Dynamic carbon fiber ankle brace.
Standard walking shoe: Standard walking shoe (control shoe) with no rocker sole.
|
Healthy Control Subjects
n=1 Participants
Ambulatory adults (18+) with no known ankle osteoarthritis.
Standard walking shoe: Standard walking shoe (control shoe) with no rocker sole.
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Age, Continuous
|
66 years
n=5 Participants
|
62 years
n=7 Participants
|
65 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Three weeksPopulation: numbers analyzed are different as there was issue with the data collection device and data were not recorded
The daily step count of a participant as measured by a body worn pedometer.
Outcome measures
| Measure |
Ankle Osteoarthritis Patients: AFO, Then RB, Then C
n=2 Participants
Ambulatory adult patients (18+) with ankle osteoarthritis. Rocker bottom shoe (RB): Walking shoe with a anterior posterior rocker sole. Ankle foot orthosis (AFO): Dynamic carbon fiber ankle brace. Control (C): Standard walking shoe (control shoe) with no rocker sole.
First Intervention (3 weeks) Washout (1 week) Second Intervention (3 weeks) Washout (1 week) Third Intervention (3 weeks)
|
Healthy Control Subjects
Ambulatory adults (18+) with no known ankle osteoarthritis.
Standard walking shoe: Standard walking shoe (control shoe) with no rocker sole.
|
Ankle Osteoarthritis Patients: C, Then RB, Then AFO
n=2 Participants
Ambulatory adult patients (18+) with ankle osteoarthritis. Rocker bottom shoe (RB): Walking shoe with a anterior posterior rocker sole. Ankle foot orthosis (AFO): Dynamic carbon fiber ankle brace. Control (C): Standard walking shoe (control shoe) with no rocker sole.
First Intervention (3 weeks) Washout (1 week) Second Intervention (3 weeks) Washout (1 week) Third Intervention (3 weeks)
|
Ankle Osteoarthritis Patients: C, Then AFO, Then RB
n=1 Participants
Ambulatory adult patients (18+) with ankle osteoarthritis. Rocker bottom shoe (RB): Walking shoe with a anterior posterior rocker sole. Ankle foot orthosis (AFO): Dynamic carbon fiber ankle brace. Control (C): Standard walking shoe (control shoe) with no rocker sole.
First Intervention (3 weeks) Washout (1 week) Second Intervention (3 weeks) Washout (1 week) Third Intervention (3 weeks)
|
Ankle Osteoarthritis Patients: RB, Then C, the AFO
n=2 Participants
Ambulatory adult patients (18+) with ankle osteoarthritis. Rocker bottom shoe (RB): Walking shoe with a anterior posterior rocker sole. Ankle foot orthosis (AFO): Dynamic carbon fiber ankle brace. Control (C): Standard walking shoe (control shoe) with no rocker sole.
First Intervention (3 weeks) Washout (1 week) Second Intervention (3 weeks) Washout (1 week) Third Intervention (3 weeks)
|
Ankle Osteoarthritis Patients: RB, the AFO, Then C
n=1 Participants
Ambulatory adult patients (18+) with ankle osteoarthritis. Rocker bottom shoe (RB): Walking shoe with a anterior posterior rocker sole. Ankle foot orthosis (AFO): Dynamic carbon fiber ankle brace. Control (C): Standard walking shoe (control shoe) with no rocker sole.
First Intervention (3 weeks) Washout (1 week) Second Intervention (3 weeks) Washout (1 week) Third Intervention (3 weeks)
|
|---|---|---|---|---|---|---|
|
Daily Step Count (# Steps)
with C
|
3453 steps
Standard Deviation 244
|
—
|
2399 steps
Standard Deviation 268
|
—
|
—
|
3453 steps
Standard Deviation NA
no standard deviation for 1 participant
|
|
Daily Step Count (# Steps)
With AFO
|
2745 steps
Standard Deviation 1613
|
—
|
933 steps
Standard Deviation 671
|
2043 steps
Standard Deviation NA
no standard deviation for 1 participant
|
503 steps
Standard Deviation NA
data were not recorded, issue with data collection device for 1 participant. therefore no SD
|
2745 steps
Standard Deviation NA
no standard deviation for 1 participant
|
|
Daily Step Count (# Steps)
With RB
|
2053 steps
Standard Deviation 776
|
—
|
2574 steps
Standard Deviation 82
|
—
|
—
|
2053 steps
Standard Deviation NA
no standard deviation for 1 participant
|
SECONDARY outcome
Timeframe: Three weeksPopulation: Due to COVID-19 delays and moving to a remote data collection, the investigators were unable to capture this outcome measure data
Range of motion of the ankle joint in degrees as measured by biplane fluoroscopy and/ or CT scan
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Three weeksPopulation: Due to COVID-19 delays and moving to a remote data collection, the investigators were unable to capture this outcome measure data
Self-selected walking speed as measured with a stop watch when walking a fixed distance.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Three weeksPopulation: Due to COVID-19 delays and moving to a remote data collection, the investigators were unable to capture this outcome measure data
Would you continue to wear the device if you were not part of the study? Why/why not?
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: three weeksPopulation: numbers analyzed are different as there was issue with the data collection device and data were not recorded
Self reported capability of physical function Min: 0 Max: 100 A higher score indicates better physical function
Outcome measures
| Measure |
Ankle Osteoarthritis Patients: AFO, Then RB, Then C
n=2 Participants
Ambulatory adult patients (18+) with ankle osteoarthritis. Rocker bottom shoe (RB): Walking shoe with a anterior posterior rocker sole. Ankle foot orthosis (AFO): Dynamic carbon fiber ankle brace. Control (C): Standard walking shoe (control shoe) with no rocker sole.
First Intervention (3 weeks) Washout (1 week) Second Intervention (3 weeks) Washout (1 week) Third Intervention (3 weeks)
|
Healthy Control Subjects
Ambulatory adults (18+) with no known ankle osteoarthritis.
Standard walking shoe: Standard walking shoe (control shoe) with no rocker sole.
|
Ankle Osteoarthritis Patients: C, Then RB, Then AFO
n=2 Participants
Ambulatory adult patients (18+) with ankle osteoarthritis. Rocker bottom shoe (RB): Walking shoe with a anterior posterior rocker sole. Ankle foot orthosis (AFO): Dynamic carbon fiber ankle brace. Control (C): Standard walking shoe (control shoe) with no rocker sole.
First Intervention (3 weeks) Washout (1 week) Second Intervention (3 weeks) Washout (1 week) Third Intervention (3 weeks)
|
Ankle Osteoarthritis Patients: C, Then AFO, Then RB
n=1 Participants
Ambulatory adult patients (18+) with ankle osteoarthritis. Rocker bottom shoe (RB): Walking shoe with a anterior posterior rocker sole. Ankle foot orthosis (AFO): Dynamic carbon fiber ankle brace. Control (C): Standard walking shoe (control shoe) with no rocker sole.
First Intervention (3 weeks) Washout (1 week) Second Intervention (3 weeks) Washout (1 week) Third Intervention (3 weeks)
|
Ankle Osteoarthritis Patients: RB, Then C, the AFO
n=1 Participants
Ambulatory adult patients (18+) with ankle osteoarthritis. Rocker bottom shoe (RB): Walking shoe with a anterior posterior rocker sole. Ankle foot orthosis (AFO): Dynamic carbon fiber ankle brace. Control (C): Standard walking shoe (control shoe) with no rocker sole.
First Intervention (3 weeks) Washout (1 week) Second Intervention (3 weeks) Washout (1 week) Third Intervention (3 weeks)
|
Ankle Osteoarthritis Patients: RB, the AFO, Then C
n=1 Participants
Ambulatory adult patients (18+) with ankle osteoarthritis. Rocker bottom shoe (RB): Walking shoe with a anterior posterior rocker sole. Ankle foot orthosis (AFO): Dynamic carbon fiber ankle brace. Control (C): Standard walking shoe (control shoe) with no rocker sole.
First Intervention (3 weeks) Washout (1 week) Second Intervention (3 weeks) Washout (1 week) Third Intervention (3 weeks)
|
|---|---|---|---|---|---|---|
|
Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function
C
|
50.9 score on a scale
Standard Deviation 8.7
|
—
|
37.3 score on a scale
Standard Deviation 7.7
|
37.9 score on a scale
Standard Deviation NA
only one participant, therefor no SD
|
43.5 score on a scale
Standard Deviation NA
only one participant, therefor no SD
|
50.9 score on a scale
Standard Deviation NA
only one participant, therefor no SD
|
|
Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function
AFO
|
52 score on a scale
Standard Deviation 5.1
|
—
|
22.5 score on a scale
Standard Deviation 7.4
|
41 score on a scale
Standard Deviation NA
only one participant, therefor no SD
|
45.6 score on a scale
Standard Deviation NA
only one participant, therefor no SD
|
52 score on a scale
Standard Deviation NA
only one participant, therefor no SD
|
|
Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function
RB
|
50.35 score on a scale
Standard Deviation 2.2
|
—
|
41.4 score on a scale
Standard Deviation 26.3
|
41.6 score on a scale
Standard Deviation NA
only one participant, therefor no SD
|
45.6 score on a scale
Standard Deviation NA
only one participant, therefor no SD
|
50 score on a scale
Standard Deviation NA
only one participant, therefor no SD
|
SECONDARY outcome
Timeframe: Three weeksPopulation: Due to COVID-19 delays and moving to a remote data collection, the investigators were unable to capture this outcome measure data
Fast walking speed as measured with a stop watch when walking a fixed distance.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Three weeksPopulation: Due to COVID-19 delays and moving to a remote data collection, the investigators were unable to capture this outcome measure data
Self-selected walking speed get out of a chair, walk to a line, turn around, walk back to the chair and sit down as measured with a stop watch.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Three weeksPopulation: Due to COVID-19 delays and moving to a remote data collection, the investigators were unable to capture this outcome measure data
Do you like the device? Why/why not?
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Three MonthsPopulation: Due to COVID-19 delays and moving to a remote data collection, the investigators were unable to capture this outcome measure data
Do you have a preference to one of the treatments? Which one? Why/why not?
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: three weeksPopulation: issue with data collection device, data were not collected for all participants
Self reported consequences of pain on relevant aspects of one's life. Min:0 Max: 100 A higher score indicates more pain interference
Outcome measures
| Measure |
Ankle Osteoarthritis Patients: AFO, Then RB, Then C
n=2 Participants
Ambulatory adult patients (18+) with ankle osteoarthritis. Rocker bottom shoe (RB): Walking shoe with a anterior posterior rocker sole. Ankle foot orthosis (AFO): Dynamic carbon fiber ankle brace. Control (C): Standard walking shoe (control shoe) with no rocker sole.
First Intervention (3 weeks) Washout (1 week) Second Intervention (3 weeks) Washout (1 week) Third Intervention (3 weeks)
|
Healthy Control Subjects
Ambulatory adults (18+) with no known ankle osteoarthritis.
Standard walking shoe: Standard walking shoe (control shoe) with no rocker sole.
|
Ankle Osteoarthritis Patients: C, Then RB, Then AFO
n=2 Participants
Ambulatory adult patients (18+) with ankle osteoarthritis. Rocker bottom shoe (RB): Walking shoe with a anterior posterior rocker sole. Ankle foot orthosis (AFO): Dynamic carbon fiber ankle brace. Control (C): Standard walking shoe (control shoe) with no rocker sole.
First Intervention (3 weeks) Washout (1 week) Second Intervention (3 weeks) Washout (1 week) Third Intervention (3 weeks)
|
Ankle Osteoarthritis Patients: C, Then AFO, Then RB
n=1 Participants
Ambulatory adult patients (18+) with ankle osteoarthritis. Rocker bottom shoe (RB): Walking shoe with a anterior posterior rocker sole. Ankle foot orthosis (AFO): Dynamic carbon fiber ankle brace. Control (C): Standard walking shoe (control shoe) with no rocker sole.
First Intervention (3 weeks) Washout (1 week) Second Intervention (3 weeks) Washout (1 week) Third Intervention (3 weeks)
|
Ankle Osteoarthritis Patients: RB, Then C, the AFO
n=1 Participants
Ambulatory adult patients (18+) with ankle osteoarthritis. Rocker bottom shoe (RB): Walking shoe with a anterior posterior rocker sole. Ankle foot orthosis (AFO): Dynamic carbon fiber ankle brace. Control (C): Standard walking shoe (control shoe) with no rocker sole.
First Intervention (3 weeks) Washout (1 week) Second Intervention (3 weeks) Washout (1 week) Third Intervention (3 weeks)
|
Ankle Osteoarthritis Patients: RB, the AFO, Then C
n=1 Participants
Ambulatory adult patients (18+) with ankle osteoarthritis. Rocker bottom shoe (RB): Walking shoe with a anterior posterior rocker sole. Ankle foot orthosis (AFO): Dynamic carbon fiber ankle brace. Control (C): Standard walking shoe (control shoe) with no rocker sole.
First Intervention (3 weeks) Washout (1 week) Second Intervention (3 weeks) Washout (1 week) Third Intervention (3 weeks)
|
|---|---|---|---|---|---|---|
|
Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference
C
|
54 score on a scale
Standard Deviation 2.8
|
—
|
56 score on a scale
Standard Deviation 14.7
|
61 score on a scale
Standard Deviation NA
only one participant, therefor no SD
|
61 score on a scale
Standard Deviation NA
only one participant, therefor no SD
|
54 score on a scale
Standard Deviation NA
only one participant, therefor no SD
|
|
Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference
AFO
|
52 score on a scale
Standard Deviation 2.2
|
—
|
22 score on a scale
Standard Deviation 4.3
|
41 score on a scale
Standard Deviation NA
only one participant, therefor no SD
|
45 score on a scale
Standard Deviation NA
only one participant, therefor no SD
|
52 score on a scale
Standard Deviation NA
only one participant, therefor no SD
|
|
Patient Reported Outcomes Measurement Information System (PROMIS) Pain Interference
RB
|
50 score on a scale
Standard Deviation 2.6
|
—
|
41 score on a scale
Standard Deviation 1
|
42 score on a scale
Standard Deviation NA
only one participant, therefor no SD
|
46 score on a scale
Standard Deviation NA
only one participant, therefor no SD
|
50 score on a scale
Standard Deviation NA
only one participant, therefor no SD
|
SECONDARY outcome
Timeframe: three weeksPopulation: issue with data collection device, data were not collected for all participants
American Academy of Orthopaedic Surgeons Foot and Ankle Module questionnaire designed to assess foot and ankle conditions. Min:0 Max: 100 Higher= better
Outcome measures
| Measure |
Ankle Osteoarthritis Patients: AFO, Then RB, Then C
n=2 Participants
Ambulatory adult patients (18+) with ankle osteoarthritis. Rocker bottom shoe (RB): Walking shoe with a anterior posterior rocker sole. Ankle foot orthosis (AFO): Dynamic carbon fiber ankle brace. Control (C): Standard walking shoe (control shoe) with no rocker sole.
First Intervention (3 weeks) Washout (1 week) Second Intervention (3 weeks) Washout (1 week) Third Intervention (3 weeks)
|
Healthy Control Subjects
Ambulatory adults (18+) with no known ankle osteoarthritis.
Standard walking shoe: Standard walking shoe (control shoe) with no rocker sole.
|
Ankle Osteoarthritis Patients: C, Then RB, Then AFO
n=2 Participants
Ambulatory adult patients (18+) with ankle osteoarthritis. Rocker bottom shoe (RB): Walking shoe with a anterior posterior rocker sole. Ankle foot orthosis (AFO): Dynamic carbon fiber ankle brace. Control (C): Standard walking shoe (control shoe) with no rocker sole.
First Intervention (3 weeks) Washout (1 week) Second Intervention (3 weeks) Washout (1 week) Third Intervention (3 weeks)
|
Ankle Osteoarthritis Patients: C, Then AFO, Then RB
n=1 Participants
Ambulatory adult patients (18+) with ankle osteoarthritis. Rocker bottom shoe (RB): Walking shoe with a anterior posterior rocker sole. Ankle foot orthosis (AFO): Dynamic carbon fiber ankle brace. Control (C): Standard walking shoe (control shoe) with no rocker sole.
First Intervention (3 weeks) Washout (1 week) Second Intervention (3 weeks) Washout (1 week) Third Intervention (3 weeks)
|
Ankle Osteoarthritis Patients: RB, Then C, the AFO
n=1 Participants
Ambulatory adult patients (18+) with ankle osteoarthritis. Rocker bottom shoe (RB): Walking shoe with a anterior posterior rocker sole. Ankle foot orthosis (AFO): Dynamic carbon fiber ankle brace. Control (C): Standard walking shoe (control shoe) with no rocker sole.
First Intervention (3 weeks) Washout (1 week) Second Intervention (3 weeks) Washout (1 week) Third Intervention (3 weeks)
|
Ankle Osteoarthritis Patients: RB, the AFO, Then C
n=1 Participants
Ambulatory adult patients (18+) with ankle osteoarthritis. Rocker bottom shoe (RB): Walking shoe with a anterior posterior rocker sole. Ankle foot orthosis (AFO): Dynamic carbon fiber ankle brace. Control (C): Standard walking shoe (control shoe) with no rocker sole.
First Intervention (3 weeks) Washout (1 week) Second Intervention (3 weeks) Washout (1 week) Third Intervention (3 weeks)
|
|---|---|---|---|---|---|---|
|
Foot and Ankle Ability Measure (FAAM)
C
|
71 score on a scale
Standard Deviation 23
|
—
|
70 score on a scale
Standard Deviation 35
|
45 score on a scale
Standard Deviation NA
only 1 participant, no SD
|
50 score on a scale
Standard Deviation NA
only 1 participant, no SD
|
72 score on a scale
Standard Deviation NA
only 1 participant, no SD
|
|
Foot and Ankle Ability Measure (FAAM)
AFO
|
92 score on a scale
Standard Deviation 1
|
—
|
63 score on a scale
Standard Deviation 26
|
57 score on a scale
Standard Deviation NA
only 1 participant, no SD
|
30 score on a scale
Standard Deviation NA
only 1 participant, no SD
|
92 score on a scale
Standard Deviation NA
only 1 participant, no SD
|
|
Foot and Ankle Ability Measure (FAAM)
RB
|
70 score on a scale
Standard Deviation 42
|
—
|
60 score on a scale
Standard Deviation 7
|
64 score on a scale
Standard Deviation NA
only 1 participant, no SD
|
51 score on a scale
Standard Deviation NA
only 1 participant, no SD
|
70 score on a scale
Standard Deviation NA
only 1 participant, no SD
|
SECONDARY outcome
Timeframe: three weeksPopulation: issue with data collection device, data were not collected for all participants
The Numeric Pain Rating Scale is a measure of pain intensity in adults in which the respondent selects a whole number (0-10) that best reflects the intensity of her / his pain. The scale will be administered verbally. scale of 1-10 higher= worse
Outcome measures
| Measure |
Ankle Osteoarthritis Patients: AFO, Then RB, Then C
n=2 Participants
Ambulatory adult patients (18+) with ankle osteoarthritis. Rocker bottom shoe (RB): Walking shoe with a anterior posterior rocker sole. Ankle foot orthosis (AFO): Dynamic carbon fiber ankle brace. Control (C): Standard walking shoe (control shoe) with no rocker sole.
First Intervention (3 weeks) Washout (1 week) Second Intervention (3 weeks) Washout (1 week) Third Intervention (3 weeks)
|
Healthy Control Subjects
Ambulatory adults (18+) with no known ankle osteoarthritis.
Standard walking shoe: Standard walking shoe (control shoe) with no rocker sole.
|
Ankle Osteoarthritis Patients: C, Then RB, Then AFO
n=2 Participants
Ambulatory adult patients (18+) with ankle osteoarthritis. Rocker bottom shoe (RB): Walking shoe with a anterior posterior rocker sole. Ankle foot orthosis (AFO): Dynamic carbon fiber ankle brace. Control (C): Standard walking shoe (control shoe) with no rocker sole.
First Intervention (3 weeks) Washout (1 week) Second Intervention (3 weeks) Washout (1 week) Third Intervention (3 weeks)
|
Ankle Osteoarthritis Patients: C, Then AFO, Then RB
n=1 Participants
Ambulatory adult patients (18+) with ankle osteoarthritis. Rocker bottom shoe (RB): Walking shoe with a anterior posterior rocker sole. Ankle foot orthosis (AFO): Dynamic carbon fiber ankle brace. Control (C): Standard walking shoe (control shoe) with no rocker sole.
First Intervention (3 weeks) Washout (1 week) Second Intervention (3 weeks) Washout (1 week) Third Intervention (3 weeks)
|
Ankle Osteoarthritis Patients: RB, Then C, the AFO
n=1 Participants
Ambulatory adult patients (18+) with ankle osteoarthritis. Rocker bottom shoe (RB): Walking shoe with a anterior posterior rocker sole. Ankle foot orthosis (AFO): Dynamic carbon fiber ankle brace. Control (C): Standard walking shoe (control shoe) with no rocker sole.
First Intervention (3 weeks) Washout (1 week) Second Intervention (3 weeks) Washout (1 week) Third Intervention (3 weeks)
|
Ankle Osteoarthritis Patients: RB, the AFO, Then C
n=1 Participants
Ambulatory adult patients (18+) with ankle osteoarthritis. Rocker bottom shoe (RB): Walking shoe with a anterior posterior rocker sole. Ankle foot orthosis (AFO): Dynamic carbon fiber ankle brace. Control (C): Standard walking shoe (control shoe) with no rocker sole.
First Intervention (3 weeks) Washout (1 week) Second Intervention (3 weeks) Washout (1 week) Third Intervention (3 weeks)
|
|---|---|---|---|---|---|---|
|
Numeric Pain Rating Scale
AFO
|
3 score on a scale
Standard Deviation 1.4
|
—
|
3.5 score on a scale
Standard Deviation 4.9
|
5 score on a scale
Standard Deviation NA
only 1 participant, no SD
|
5 score on a scale
Standard Deviation NA
only 1 participant, no SD
|
3 score on a scale
Standard Deviation NA
only 1 participant, no SD
|
|
Numeric Pain Rating Scale
C
|
3.5 score on a scale
Standard Deviation 2.1
|
—
|
5 score on a scale
Standard Deviation 2.8
|
5 score on a scale
Standard Deviation NA
only 1 participant, no SD
|
2 score on a scale
Standard Deviation NA
only 1 participant, no SD
|
3.5 score on a scale
Standard Deviation NA
only 1 participant, no SD
|
|
Numeric Pain Rating Scale
RB
|
2.5 score on a scale
Standard Deviation 0.7
|
—
|
3 score on a scale
Standard Deviation 4.2
|
6 score on a scale
Standard Deviation NA
only 1 participant, no SD
|
7 score on a scale
Standard Deviation NA
only 1 participant, no SD
|
2.5 score on a scale
Standard Deviation NA
only 1 participant, no SD
|
Adverse Events
Ankle Foot Orthosis (AFO)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Healthy Control Subjects
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Rocker Bottom Shoe (RB)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control (C)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ankle Foot Orthosis (AFO)
n=8 participants at risk
Ankle foot orthosis (AFO): Dynamic carbon fiber ankle brace.
|
Healthy Control Subjects
n=1 participants at risk
Ambulatory adults (18+) with no known ankle osteoarthritis.
Standard walking shoe: Standard walking shoe (control shoe) with no rocker sole.
|
Rocker Bottom Shoe (RB)
n=8 participants at risk
Rocker bottom shoe (RB): Walking shoe with a anterior posterior rocker sole.
|
Control (C)
n=8 participants at risk
Control (C): Standard walking shoe (control shoe) with no rocker sole.
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
infection
|
0.00%
0/8 • 6 weeks
we did not expect mortality during this study
|
0.00%
0/1 • 6 weeks
we did not expect mortality during this study
|
0.00%
0/8 • 6 weeks
we did not expect mortality during this study
|
12.5%
1/8 • Number of events 1 • 6 weeks
we did not expect mortality during this study
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place