Reducing Foot Pain and Peak Plantar Pressure in Patients With Foot Pain

A Comparison of the Effectiveness of OrthoFeet HandsFree Therapeutic Shoes in Reducing Foot Pain and Peak Plantar Pressure

The research project aims to evaluate the effectiveness of OrthoFeet Hands-Free therapeutic shoes and prefabricated inserts in patients with foot pain.

Study Overview

• Status: Recruiting
• Conditions: Foot Pain
• Intervention / Treatment: Device: OrthoFeet HandsFree Therapeutic Shoe

Detailed Description

Patients with foot pain frequently have gait dysfunctions resulting in higher mechanical stress and peak plantar pressure in some areas of the foot. Older people with foot pain have impaired balance and reduced walking speed compared to those without foot pain. Higher peak plantar pressure further increases the risk of falls in older populations. By wearing custom-fit devices, such as prefabricated depth shoes, footwear modifications, and orthoses, patients can redistribute pressure by lowering the peak plantar pressure in specific areas. Similarly, these custom-fit devices and shoes may mitigate the level of pain in patients after wearing the shoes for a certain period. Understanding how different orthotics, shoes, and inserts redistribute plantar pressure and lower foot pain is essential to prescribing the proper footwear to foot pain patients. The proposed study will investigate the effectiveness of OrthoFeet Hands-Free therapeutic shoes and prefabricated inserts in patients with foot pain compared to their own shoes. This will be achieved by completing four aims. The first aim will determine the patient shoe wearing compliance, comfort, acceptance, and feasibility of OrthoFeet Hands-Free therapeutic shoes in patients with foot pain. For the second aim, the investigators will determine the effectiveness of reducing foot pain after a 6-weeks intervention of wearing OrthoFeet Hands-Free therapeutic shoes. The third aim will determine the progressive improvements in physical activity, quality of life, and reduction in peak plantar pressure following a 6-weeks intervention period. For the fourth aim, the investigators will compare the effectiveness of reducing plantar pressure between OrthoFeet Hands-Free therapeutic shoes and patients own shoes. The investigators hypothesize that the degree of foot pain mitigates with reduced peak plantar pressure in patients with foot pain after a 6-weeks intervention of wearing OrthoFeet Hands-Free therapeutic shoes greater than occurs when patients continue to wear their own customary shoes. The outcomes from the study will provide a better scenario of how the OrthoFeet shoes and inserts impact the plantar pressure distribution during walking in patients with foot pain. This will further help in future research studies to modify existing designs and guide the development of novel therapeutic treatments for foot pain patients.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hafizur Rahman, PhD; Phone Number: 9562962035; Email: hafizur.rahman@utrgv.edu

Study Locations

• United States
  • Texas
    • Harlingen, Texas, United States, 78550
      • Recruiting
      • Hafizur Rahman
      • Contact: Hafizur Rahman Rahman, PhD; Phone Number: (956) 296-2035; Email: hafizur.rahman@utrgv.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• be able to give written, informed consent
• self-reported foot pain including heel pain, arch or ball of the foot pain, and hallux limitus/rigidus joint pain
• not engaged in any physician prescribed treatment plan
• in-tact protective sensation as determined using Semmes Weinstein monofilament

Exclusion Criteria:

• patients with plantar ulcer
• patients with major foot deformities such as charcot foot, pes cavus
• patients with lower extremity amputation including minor amputation
• foot pain because of nail disorder of keratotic lesions
• patients with unstable conditions such as recent stroke, anticipated changes in medication regime
• acute fractures of the foot
• patients with major cognitive impairment or major depression
• patients with lower extremity decreased protective sensation
• engaged in any treatment of foot pain including icing, oral anti-inflammatories, creams, injections, physical therapy
• swelling

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Own Shoe; Patients wearing their own appropriate shoes
Experimental: OrthoFeet shoe; Patients wearing OrthoFeet shoes with standard inserts	Device: OrthoFeet HandsFree Therapeutic Shoe; Patients with foot pain will be recruited for this study and will go for an intervention of wearing OrthoFeet therapeutic shoes for 6 weeks. Each patient will be evaluated and will participate in data collection before and after intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Foot pain	Foot pain will be assessed using the Foot Function Index (FFI) questionnaire. It has three subsections: pain, disability, and activity limitation. The scores for the pain and disability subsections range from 0 to 90 (0 represents best and 90 represents worst), and the score for activity limitation ranges from 0 to 50 (0 represents best and 50 represents worst).	Baseline, 6 weeks, 12 weeks
In-shoe Peak Plantar pressure	In-shoe peak plantar pressure data will be recorded as patients walk with a pressure-measuring sensor placed inside their shoes. The unit will be Kilopascal (kPa).	Baseline, 6 weeks, 12 weeks
Pressure-Time Integral	Pressure-Time integral data for different foot regions will be measured as patients walk with a pressure-measuring sensor placed inside their shoes. The unit will be Kilopascal-sec (kPa-s).	Baseline, 6 weeks, 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life	Medical Outcomes Study 36-item Short Form questionnaires (SF-36) will be used to assess the quality of life. The SF-36 form has four subsections: pain, distance, walking speed, and stair climbing. Each subsection score ranges from 0 to 100 (where 0 is the worst, and 100 is the best health status).	Baseline, 6 weeks, 12 weeks
Physical activity	Physical activity will be expressed in terms of average steps per day. Patients will wear Actigraph accelerometers for seven consecutive days, and we will record the average steps per day.	Baseline, 6 weeks, 12 weeks

Collaborators and Investigators

• Sponsor: University of Texas Rio Grande Valley

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2024
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): April 30, 2026

Study Registration Dates

• First Submitted: May 29, 2024
• First Submitted That Met QC Criteria: July 17, 2024
• First Posted (Actual): July 24, 2024

Study Record Updates

• Last Update Posted (Actual): February 20, 2026
• Last Update Submitted That Met QC Criteria: February 18, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: IRB 23-0032

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: A de-identified and anonymous dataset will be created for sharing purposes. The dataset will only be shared upon reasonable request and with a written agreement from the recipient. All outcomes, results, and findings will be published in peer-reviewed journals and conference proceedings.
• IPD Sharing Time Frame: The de-identified and anonymous dataset will only be shared after the study is completed and results are published in peer-reviewed journals and conference proceedings.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No