Trial Outcomes & Findings for Orthofeet: A Prospective Proof of Concept Trial to Evaluate an Innovative Pain Relief Footwear (NCT NCT05434078)
NCT ID: NCT05434078
Last Updated: 2024-12-24
Results Overview
Changes in foot pain from baseline to 6 weeks for each intervention (Orthofeet and own shoes) will be assessed using the Foot Function Index (FFI) questionnaire. The FFI consists of four overall scores, including three subscales: 1) Pain Score (the primary outcome in this study), 2) Disability Score, 3) Activity Limitation Score, and 4) Overall Score. The Pain subscale asks participants to rate their foot pain on a scale of 0 (no pain) to 10 (worst imaginable pain), based on their experiences during various activities over the past two weeks. For this outcome, we focused on the FFI pain subscore related to the worst foot pain experienced over the last two weeks. To report the final results, participants from intervention A (Orthofeet) and intervention B (own shoes) were combined from groups AB and BA.
COMPLETED
PHASE1/PHASE2
50 participants
baseline, week 6
2024-12-24
Participant Flow
Participants were recruited from the Baylor Outpatient Clinic (Houston, Texas, USA) via electronic health records, peer referrals, study flyers, and from among participants in prior clinical studies who had agreed to be contacted for new studies. This trial's timeline started at the initial recruitment date of of the firts participant on July 18th, 2022, and concluded at the final follow-up date of August 30th, 2023
Participant milestones
| Measure |
OrthoFeet Shoes First, Then Own Shoes
In the group AB (OrthoFeet Shoes first, then Own Shoes), participants wore OrthoFeet shoes for 6 weeks and then their own shoes for another 6 weeks
|
Own Shoes First, Then OrthoFeet Shoes
Group BA (Own Shoes first, then OrthoFeet Shoes) followed the reverse order of Group AB, meaning they first wore their own shoes for 6 weeks and then switched to Orthofeet shoes for the subsequent 6 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
22
|
24
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
| Measure |
OrthoFeet Shoes First, Then Own Shoes
In the group AB (OrthoFeet Shoes first, then Own Shoes), participants wore OrthoFeet shoes for 6 weeks and then their own shoes for another 6 weeks
|
Own Shoes First, Then OrthoFeet Shoes
Group BA (Own Shoes first, then OrthoFeet Shoes) followed the reverse order of Group AB, meaning they first wore their own shoes for 6 weeks and then switched to Orthofeet shoes for the subsequent 6 weeks.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Orthofeet: A Prospective Proof of Concept Trial to Evaluate an Innovative Pain Relief Footwear
Baseline characteristics by cohort
| Measure |
OrthoFeet Shoes First, Then Own Shoes
n=22 Participants
Group AB (OrthoFeet Shoes first, then Own Shoes) started with 6-week Intervention A (OrthoFeet) and then switched to 6-week intervention B (own shoes)
|
Own Shoes First, Then OrthoFeet Shoes
n=24 Participants
Group BA (Own Shoes first, then OrthoFeet Shoes) started with B (own shoes) for 6 weeks and then switched to Intervention A (OrthoFeet) for the same duration
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65 years
STANDARD_DEVIATION 5 • n=5 Participants
|
66 years
STANDARD_DEVIATION 5 • n=7 Participants
|
65 years
STANDARD_DEVIATION 5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Ethnicity (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
|
22 participants
n=5 Participants
|
24 participants
n=7 Participants
|
46 participants
n=5 Participants
|
|
History of fall
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline, week 6Population: This study uses a crossover design. Please note that Intervention A comprises data from the first six weeks of Group AB and the last six weeks of Group BA, while Intervention B comprises data from the last six weeks of Group AB and the first six weeks of Group BA. Consequently, the total number of participants is the sum of Group AB and Group BA, which is identical for both Intervention A and Intervention B. Four subjects (out of 50) were lost in follow-up
Changes in foot pain from baseline to 6 weeks for each intervention (Orthofeet and own shoes) will be assessed using the Foot Function Index (FFI) questionnaire. The FFI consists of four overall scores, including three subscales: 1) Pain Score (the primary outcome in this study), 2) Disability Score, 3) Activity Limitation Score, and 4) Overall Score. The Pain subscale asks participants to rate their foot pain on a scale of 0 (no pain) to 10 (worst imaginable pain), based on their experiences during various activities over the past two weeks. For this outcome, we focused on the FFI pain subscore related to the worst foot pain experienced over the last two weeks. To report the final results, participants from intervention A (Orthofeet) and intervention B (own shoes) were combined from groups AB and BA.
Outcome measures
| Measure |
OrthoFeet Shoes
n=46 Participants
Intervention A (OrthoFeet Shoes) involves wearing a pair of OrthoFeet shoes (OrthoFeet©, NJ, USA) for six weeks.
|
Own Shoes
n=46 Participants
Intervention B (Own Shoes, as comparator) involves wearing the participant's own regular shoes for a duration of six weeks.
|
|---|---|---|
|
Foot Pain at Its Worst at Baseline and Week 6
Baseline
|
6.4 unit on scale
Standard Deviation 2.7
|
5.3 unit on scale
Standard Deviation 3.2
|
|
Foot Pain at Its Worst at Baseline and Week 6
week 6
|
3.6 unit on scale
Standard Deviation 2.8
|
5.4 unit on scale
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: from baseline to 6 weeksPopulation: Data from twenty-nine participants (out of 46 recruited) with valid physical activity monitoring during both sequences-A (Orthofeet shoes) and B (own shoes)-were included in this secondary analysis. Data from the remaining participants were excluded due to invalid physical activity records.
Step count will be measured over the course of 6 weeks for each intervention arm (Intervention A (Orthofeet) and Intervention B (own shoes)) using a smartwatch (Vivosmart 4, Garmin, USA). Steps per day were recorded in 15-min intervals and summed over each 24-h period. For analysis, the mean daily steps from the last seven consecutive days of each footwear condition (A and B) were calculated for each participant.
Outcome measures
| Measure |
OrthoFeet Shoes
n=29 Participants
Intervention A (OrthoFeet Shoes) involves wearing a pair of OrthoFeet shoes (OrthoFeet©, NJ, USA) for six weeks.
|
Own Shoes
n=29 Participants
Intervention B (Own Shoes, as comparator) involves wearing the participant's own regular shoes for a duration of six weeks.
|
|---|---|---|
|
Step Count
|
5456 steps/day
Standard Deviation 476
|
4758 steps/day
Standard Deviation 474
|
SECONDARY outcome
Timeframe: from baseline to 6 weeksPopulation: Data from twenty-nine participants (out of 46 recruited) with valid physical activity monitoring during both sequences-A (Orthofeet shoes) and B (own shoes)-were included in this secondary analysis. Data from the remaining participants were excluded due to invalid physical activity records.
Active kilocalories (calories burned through physical activity, excluding basal metabolic rate) measured by the smartwatch (Vivosmart watch, Garmin) over the last seven consecutive days were extracted for each intervention period: A (Orthofeet) and B (own shoes). The 90th percentile of daily active kilocalories recorded by the smartwatch from baseline to 6 weeks was included in the analysis.
Outcome measures
| Measure |
OrthoFeet Shoes
n=29 Participants
Intervention A (OrthoFeet Shoes) involves wearing a pair of OrthoFeet shoes (OrthoFeet©, NJ, USA) for six weeks.
|
Own Shoes
n=29 Participants
Intervention B (Own Shoes, as comparator) involves wearing the participant's own regular shoes for a duration of six weeks.
|
|---|---|---|
|
Daily Energy Expenditure
|
532 Kcal/day
Standard Deviation 119
|
354 Kcal/day
Standard Deviation 56
|
SECONDARY outcome
Timeframe: baseline, week 6Foot pain at baseline and 6 weeks for each intervention (Orthofeet and own shoes) will be assessed using the Foot Function Index (FFI) questionnaire. The pain subscale asks participants to rate their foot pain on a scale from 0 (no pain) to 10 (worst imaginable pain) based on their experiences during various activities over the past two weeks. Seven of the nine questions were summed for final analysis, excluding "pain walking with orthotics" and "pain standing with orthotics," as the focus was to compare Orthofeet shoes to participants' own shoes, not prescribed orthoses. The resulting total score ranges from 0 to 70, with higher values indicating worse overall pain.
Outcome measures
| Measure |
OrthoFeet Shoes
n=46 Participants
Intervention A (OrthoFeet Shoes) involves wearing a pair of OrthoFeet shoes (OrthoFeet©, NJ, USA) for six weeks.
|
Own Shoes
n=46 Participants
Intervention B (Own Shoes, as comparator) involves wearing the participant's own regular shoes for a duration of six weeks.
|
|---|---|---|
|
Pain Score at Baseline and Week 6
baseline
|
34.7 unit on scale
Standard Deviation 15.9
|
33 unit on scale
Standard Deviation 17.5
|
|
Pain Score at Baseline and Week 6
week 6
|
22.8 unit on scale
Standard Deviation 16.4
|
31.4 unit on scale
Standard Deviation 22.2
|
SECONDARY outcome
Timeframe: baseline, week 6The disability level at baseline and week 6 was assessed using the disability subscale of the Foot Function Index (FFI). This subscale consists of nine items that evaluate the difficulty experienced in performing various functional activities due to foot problems. These activities include walking inside and outside the house, climbing and descending stairs, getting out of a chair, standing on tiptoe, climbing curbs, and running or fast walking. Each item is rated on a scale from 0 (no difficulty) to 10 (so difficult it requires help). The scores for the disability subscale range from 0 to 90, with higher scores indicating greater disability.
Outcome measures
| Measure |
OrthoFeet Shoes
n=46 Participants
Intervention A (OrthoFeet Shoes) involves wearing a pair of OrthoFeet shoes (OrthoFeet©, NJ, USA) for six weeks.
|
Own Shoes
n=46 Participants
Intervention B (Own Shoes, as comparator) involves wearing the participant's own regular shoes for a duration of six weeks.
|
|---|---|---|
|
Disability at Baseline and Week 6
baseline
|
38.5 unit on scale
Standard Deviation 22.4
|
35.5 unit on scale
Standard Deviation 25.5
|
|
Disability at Baseline and Week 6
week 6
|
24.9 unit on scale
Standard Deviation 8.5
|
31.4 unit on scale
Standard Deviation 22.2
|
SECONDARY outcome
Timeframe: baseline, week 6Physical activity limitations at baseline and were assessed using the Activity Limitation subscale of the Foot Function Index (FFI). This subscale comprises five items that evaluate the extent to which foot problems restrict a person's physical activities, including walking distances, standing on tiptoe, climbing stairs, and engaging in vigorous activities. Each item is rated on a scale from 0 (no limitation) to 10 (maximum limitation), with higher scores indicating greater activity limitation. The total score for this subscale ranges from 0 to 50. In this study, changes from baseline at week 6 for each intervention duration were assessed and reported. In this study the changes from baseline at week 6 for each intervention duration was assessed and reported
Outcome measures
| Measure |
OrthoFeet Shoes
n=46 Participants
Intervention A (OrthoFeet Shoes) involves wearing a pair of OrthoFeet shoes (OrthoFeet©, NJ, USA) for six weeks.
|
Own Shoes
n=46 Participants
Intervention B (Own Shoes, as comparator) involves wearing the participant's own regular shoes for a duration of six weeks.
|
|---|---|---|
|
Physical Activity Limitation
baseline
|
13.3 unit on scale
Standard Deviation 9.4
|
12.2 unit on scale
Standard Deviation 10
|
|
Physical Activity Limitation
week 6
|
9.9 unit on scale
Standard Deviation 8.5
|
10.5 unit on scale
Standard Deviation 8.7
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: Data from twenty-nine participants (out of 46 recruited) with valid physical activity monitoring during both sequences-A (Orthofeet shoes) and B (own shoes)-were included in this secondary analysis. Data from the remaining participants were excluded due to invalid physical activity records.
We used a Garmin smartwatch to report the Daily Metabolic Equivalent of Task (METs). Median daily MET values over the last seven consecutive days for each participant, during each footwear condition (Orthofeet shoes and their own shoes), were calculated following the guidelines of the American College of Sports Medicine (ACSM) and the American Heart Association (AHA) (Haskell et al., 2007). To calculate MET-minutes per week (MET·min·wk-¹), the median daily METs were multiplied by 60, as recommended by ACSM and AHA. The mean values for the calculated "Median daily MET" across all participants, during periods when they wore Orthofeet shoes and their own shoes, were computed and reported.
Outcome measures
| Measure |
OrthoFeet Shoes
n=29 Participants
Intervention A (OrthoFeet Shoes) involves wearing a pair of OrthoFeet shoes (OrthoFeet©, NJ, USA) for six weeks.
|
Own Shoes
n=29 Participants
Intervention B (Own Shoes, as comparator) involves wearing the participant's own regular shoes for a duration of six weeks.
|
|---|---|---|
|
Daily Metabolic Equivalent of Task (METS)
|
461 MET-minutes per week
Standard Deviation 22
|
427 MET-minutes per week
Standard Deviation 17
|
Adverse Events
Orthofeet Shoes
Own Shoes
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