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 proof of concept study is to examine the effectiveness of a new pain relief footwear (Orthofeet) on function and daily activities. he investigators hypothesize that Orthofeet will reduce foot pain leading to an increase in daily physical activities, measured objectives using validated wearables (PAMSys and Garmin wristwatch), and functional performance (gait and balance). In addition, the investigators hypothesis that reduction in foot pain is associated with reduced physiological stress response (HRV) and better community engagement (assessed by life space questionnaire).

Study Overview

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

Detailed Description

A clinical study at the Baylor College of Medicine, to evaluate short and intermediate benefits and effectiveness of a novel pain relief footwear, called Orthofeet. This is a randomized crossed over trial. The duration of the study would be 12-week. The investigators will recruit 50 eligible ambulatory adults (age 50 years or older) with moderate to severe self-reported foot pain. Participants will be randomly assigned to Group A (25 subjects) and Group B (25 subjects). There is no difference in assessments or eligibility between Group A and Group B, the only difference is when they have the opportunity to try the shoes for 6 weeks. Group A will receive a pair of Orthofeet shoes with adjustable insoles and will be asked to wear it every day activities of daily living for duration of six weeks. Participants will be also encourage to wear the shoes inside of home if possible. Group B will be followed for duration of six weeks. At six weeks the groups will be switched and group B will receive and a pair of Orthofeet shoes with adjustable insoles and Group B will follow-up for six week without Orthofeet shoes. Participants will be assessed at baseline, week-1, week-6, week 7, and week 12.

• 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
Experimental: Orthofeet Shoes; Participants will be given Orthofeet shoes to wear for 6 weeks	Device: Orthofeet Shoes; Participants will wear a pair of Orthofeet shoes to wear for 6 weeks
No Intervention: No Orthofeet shoes; This group will not be wearing Orthofeet shoes for 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Foot Pain Intensity	Changes in foot pain from baseline to 12 weeks will be assessed by Foot Function Index (FFI) questionnaire. Score ranges from 0 to 230, the higher the score indicates greater disability/decreased foot function.	baseline, 1 week, 6 weeks, 7 weeks, 12 weeks
Change in step count from baseline to 6 weeks to 12 weeks	Step count will be measured over the course of 12 weeks using a smart watch (Vivosmart 4, Garmin, USA)	12 weeks from baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Physical Activity	Changes in physical activity from baseline to 12 weeks will be assessed. Physical activity will be quantified by measuring number of taken steps per day and will be measured using a validated wearable sensor named PAMSys. Monitoring of physical activity will be done during 48hours at baseline, 6 weeks, and at 12 weeks.	baseline, 6 weeks, and 12 weeks
Change in Quality of Life	Quality of life will be assessed using a validated questionnaire, called PROMIS Global-10. The PROMIS Global-10 is a 10-item patient-reported questionnaire in which the response options are presented as 5-point (as well as a single 11-point) rating scales. The results of the questions are used to calculate two summary scores: a Global Physical Health Score and a Global Mental Health score. These scores are then standardized to the general population, using the "T-Score". The average "T-Score" for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient.	baseline, 6 weeks, and 12 weeks
Change in Gait speed	Change from baseline in Gait speed at 12 weeks. Gait speed will be measured using a validated wearable platform (LEGSys) during habitual walking speed.	baseline, 6 weeks, and 12 weeks
Change in Balance	Change in balance from baseline to 12 weeks will be measured. Balance will be assessed by measuring center of mass sway. The investigator will use a validated wearable platform (BalanSen) to measure body sway.	baseline, 6 weeks, and 12 weeks
Change in Fear of Falling	Changes in Fear of falling will be assessed by Short Falls Efficacy Scale International (FES I) questionnaire at 12 weeks and will be compared to baseline measurements. Scores range from 16 to 64, the higher the score the more concerned the subject is with falling.	baseline, 6 weeks, and 12 weeks
Change in Cognitive Function	Changes from baseline in cognitive function at 12 weeks. Cognitive performance will be assessed using Montreal Cognitive Assessment (MoCA). Scores on the MoCA range from zero to 30, with a score of 26 and higher generally considered normal.	baseline, 6 weeks, and 12 weeks

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): July 4, 2022
• Primary Completion (Actual): August 30, 2023
• Study Completion (Actual): August 30, 2023

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): October 12, 2023
• Last Update Submitted That Met QC Criteria: October 10, 2023
• Last Verified: October 1, 2023

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