Evaluating therapeutic shoes for foot pain relief
A Comparison of the Effectiveness of OrthoFeet HandsFree Therapeutic Shoes in Reducing Foot Pain and Peak Plantar Pressure
This study tests if wearing special therapeutic shoes can help older adults with foot pain feel better and improve their walking.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 50 Years to 70 Years |
| Sex | All |
| Sponsor | University of Texas Rio Grande Valley Academic / other |
| Locations | 1 site (Harlingen, Texas) |
| Trial ID | NCT06516900 on ClinicalTrials.gov |
What this trial studies
This research project aims to assess the effectiveness of OrthoFeet Hands-Free therapeutic shoes and prefabricated inserts in alleviating foot pain among patients. The study will focus on how these custom-fit devices can redistribute pressure and reduce peak plantar pressure, which is crucial for improving gait and balance in older adults. Participants will wear the therapeutic shoes for six weeks, during which their compliance, comfort, and pain levels will be monitored. The study seeks to provide insights into the best footwear options for individuals suffering from various types of foot pain.
Who should consider this trial
Good fit: Ideal candidates include individuals experiencing self-reported foot pain without engaging in any current treatment plans.
Not a fit: Patients with major foot deformities, recent fractures, or those currently receiving treatment for foot pain may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce foot pain and improve mobility for patients suffering from foot-related issues.
How similar studies have performed: Other studies have shown promising results with similar therapeutic footwear approaches, indicating potential for success in this study.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Harlingen, Texas
- Hafizur Rahman — Harlingen, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Hafizur Rahman, PhD
- Email: hafizur.rahman@utrgv.edu
- Phone: 9562962035
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.