Skip to main content
OpenTrials
Completed

NCT Number: NCT06516900

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hafizur Rahman

Harlingen, Texas, 78550, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OrthoFeet HandsFree Therapeutic Shoe

Device

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.

Primary outcomes

  1. Foot pain

    Time frame: Baseline, 6 weeks, 12 weeks

    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).

  2. In-shoe Peak Plantar pressure

    Time frame: Baseline, 6 weeks, 12 weeks

    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).

  3. Pressure-Time Integral

    Time frame: Baseline, 6 weeks, 12 weeks

    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).

Secondary outcomes

  1. Quality of life

    Time frame: Baseline, 6 weeks, 12 weeks

    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).

  2. Physical activity

    Time frame: Baseline, 6 weeks, 12 weeks

    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.

Sponsors and collaborators

Lead sponsor

University of Texas Rio Grande Valley

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 24, 2024
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.