Orthofeet: A Prospective Proof of Concept Trial to Evaluate Efficacy, Acceptability, and Perception of Benefit of an Innovative Pain Relief Footwear
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Foot Pain at Its Worst at Baseline and Week 6
Study Overview
Brief Summary
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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Group AB
Group AB will be started with 6-week Intervention A (OrthoFeet) and then switched to 6-week intervention B (own shoes)
Intervention: Orthofeet Shoes (Device)
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
Outcomes
Primary Outcomes
Foot Pain at Its Worst at Baseline and Week 6
Time Frame: baseline, 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.
Secondary Outcomes
- Step Count(from baseline to 6 weeks)
- Daily Energy Expenditure(from baseline to 6 weeks)
- Pain Score at Baseline and Week 6(baseline, week 6)
- Disability at Baseline and Week 6(baseline, week 6)
- Physical Activity Limitation(baseline, week 6)
- Daily Metabolic Equivalent of Task (METS)(6 weeks)
Investigators
Bijan Najafi, PhD
Principal Investigator
Baylor College of Medicine