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| Name | Class |
|---|---|
| Orthofeet, Inc. | UNKNOWN |
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The purpose of this prospective randomized crossover study is to evaluate the effectiveness of a new pain relief footwear, Orthofeet, in reducing foot pain and improving daily physical activity. The investigators hypothesize that wearing Orthofeet shoes will lead to a reduction in foot pain, resulting in increased daily physical activity, objectively measured using validated wearable devices.
A clinical study at Baylor College of Medicine is being conducted to evaluate the short- and intermediate-term benefits and effectiveness of a novel pain relief footwear, Orthofeet. This 12-week randomized crossover trial aims to recruit 50 eligible ambulatory adults (aged 50 years or older) with moderate self-reported foot pain. Participants will be randomly assigned to Group AB (25 subjects) or Group BA (25 subjects), with no differences in assessments or eligibility criteria between the groups. In Group AB, participants will wear Orthofeet shoes for 6 weeks, followed by their own shoes for another 6 weeks, while Group BA will follow the reverse order. Pain and function, the primary outcomes, will be measured using the Foot Function Index (FFI), and acceptability will be assessed using a Technology Acceptance Model (TAM) questionnaire. Data will be collected at baseline, 6 weeks, and 12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group AB | Active Comparator | Group AB will be started with 6-week Intervention A (OrthoFeet) and then switched to 6-week intervention B (own shoes) |
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| Group BA | No Intervention | Group BA will be started with B (own shoes) for 6 weeks and then switched to Intervention A (OrthoFeet) for the same duration |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Orthofeet Shoes | Device | Participants will wear a pair of Orthofeet shoes to wear for 6 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Foot Pain at Its Worst at Baseline and Week 6 | 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. | baseline, week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Step Count | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38776890 | Background | Finco MG, Ouattas A, El-Refaei N, Momin AS, Azarian M, Najafi B. Assessing the Acceptability and Effectiveness of a Novel Therapeutic Footwear in Reducing Foot Pain and Improving Function among Older Adults: A Crossover Randomized Controlled Trial. Gerontology. 2024;70(8):842-854. doi: 10.1159/000539307. Epub 2024 May 22. | |
| 39954566 |
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Only de-identified data and associated results will be published in peer-reviewed papers or scientific abstracts
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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
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Few subjects were lost to follow up.
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| ID | Title | Description |
|---|---|---|
| BG000 | OrthoFeet Shoes First, Then Own Shoes | 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) |
| BG001 | Own Shoes First, Then OrthoFeet Shoes |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Foot Pain at Its Worst at Baseline and Week 6 | 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. | 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 | Posted | Mean | Standard Deviation | unit on scale | baseline, week 6 |
6 weeks
An adverse event (AE) is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (e.g., worsening foot pain, falls, allergy), symptom, or disease, temporally associated with the participant's involvement in the research, whether or not considered related to their participation.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Orthofeet Shoes | Intervention A (orthofeet shoes) involves wearing a pair of OrthoFeet shoes (OrthoFeet©, NJ, USA) for six weeks. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Bijan Najafi | Baylor College of Medicine | +1 (424) 467-7127 | bijan.najafi@bcm.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 15, 2022 | Nov 18, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 16, 2022 | Nov 18, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000073496 | Frailty |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| from baseline to 6 weeks |
| Daily Energy Expenditure | 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. | from baseline to 6 weeks |
| Pain Score at Baseline and Week 6 | Foot 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. | baseline, week 6 |
| Disability at Baseline and Week 6 | The 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. | baseline, week 6 |
| Physical Activity Limitation | Physical 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 | baseline, week 6 |
| Daily Metabolic Equivalent of Task (METS) | 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. | 6 weeks |
| Ouattas A, Finco MG, Dehghan Rouzi M, Azarian M, Rojas AZ, Bargas Ochoa M, El-Refaei N, Momin A, Najafi B. The role of therapeutic footwear to increase daily physical activity in older adults with chronic foot pain. Clin Biomech (Bristol). 2025 Mar;123:106373. doi: 10.1016/j.clinbiomech.2024.106373. Epub 2024 Oct 29. |
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 |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| History of fall | Count of Participants | Participants |
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| Secondary | Step Count | 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. | 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. | Posted | Mean | Standard Deviation | steps/day | from baseline to 6 weeks |
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| Secondary | Daily Energy Expenditure | 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. | 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. | Posted | Mean | Standard Deviation | Kcal/day | from baseline to 6 weeks |
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| Secondary | Pain Score at Baseline and Week 6 | Foot 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. | Posted | Mean | Standard Deviation | unit on scale | baseline, week 6 |
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|
| Secondary | Disability at Baseline and Week 6 | The 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. | Posted | Mean | Standard Deviation | unit on scale | baseline, week 6 |
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|
| Secondary | Physical Activity Limitation | Physical 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 | Posted | Mean | Standard Deviation | unit on scale | baseline, week 6 |
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|
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| Secondary | Daily Metabolic Equivalent of Task (METS) | 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. | 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. | Posted | Mean | Standard Deviation | MET-minutes per week | 6 weeks |
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| 0 |
| 46 |
| 0 |
| 46 |
| 0 |
| 46 |
| EG001 | Own Shoes | Intervention B (own shoes, as comparator) involves wearing the participant's own regular shoes for a duration of six weeks. | 0 | 46 | 0 | 46 | 0 | 46 |
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