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

NCT ID: NCT06516900

Last Updated: 2025-08-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-05
• Study Completion Date: 2025-12-31

Brief Summary

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

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.

Conditions

Foot Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Own Shoe

Patients wearing their own appropriate shoes

Group Type: NO_INTERVENTION

No interventions assigned to this group

OrthoFeet shoe

Patients wearing OrthoFeet shoes with standard inserts

Group Type: EXPERIMENTAL

OrthoFeet HandsFree Therapeutic Shoe

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Texas Rio Grande Valley

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hafizur Rahman

Harlingen, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Hafizur Rahman, PhD

Role: CONTACT

hafizur.rahman@utrgv.edu

9562962035

Facility Contacts

Hafizur Rahman Rahman, PhD

Role: primary

hafizur.rahman@utrgv.edu

(956) 296-2035

Other Identifiers

IRB 23-0032

Identifier Type: -

Identifier Source: org_study_id