Orthofeet: A Prospective Proof of Concept Trial to Evaluate an Innovative Pain Relief Footwear

Orthofeet: A Prospective Proof of Concept Trial to Evaluate Efficacy, Acceptability, and Perception of Benefit of an Innovative Pain Relief Footwear

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.

Study Overview

• Status: Completed
• Conditions: Foot Pain
• Intervention / Treatment: Device: Orthofeet Shoes

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 50 years or older
• self reported foot pain including heel, arch, or ball of foot

Exclusion Criteria:

• Plantar ulcer Patients with major foot deformity (e.g., Charcot foot, Pes Cavus)
• Lower extremity amputation including minor amputation. Foot pain because of nail disorder or keratotic lesions (e.g. corns, calluses)
• unstable conditions such as recent stroke, anticipated changes in medication regime
• Acute fractures of the foot
• Non-ambulatory or unable to stand without help or walk a distance of at least 6 feet without assistance.
• major cognitive impairment or major depression

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group AB; Group AB will be started with 6-week Intervention A (OrthoFeet) and then switched to 6-week intervention B (own shoes)	Device: Orthofeet Shoes; Participants will wear a pair of Orthofeet shoes to wear for 6 weeks
No Intervention: Group BA; Group BA will be started with B (own shoes) for 6 weeks and then switched to Intervention A (OrthoFeet) for the same duration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Bijan Najafi, PhD
• Collaborators: Orthofeet, Inc.

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2022
• Primary Completion (Actual): August 30, 2023
• Study Completion (Actual): August 30, 2024

Study Registration Dates

• First Submitted: June 22, 2022
• First Submitted That Met QC Criteria: June 22, 2022
• First Posted (Actual): June 27, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 12, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: frailty; falls; mobility; foot pain; footwear
• Other Study ID Numbers: 51229

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Only de-identified data and associated results will be published in peer-reviewed papers or scientific abstracts

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes