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

The University of Texas System (UT)

Status

Enrolling

Conditions

Foot Pain

Treatments

Device: OrthoFeet HandsFree Therapeutic Shoe

Study type

Interventional

Funder types

Other

Identifiers

NCT06516900

IRB 23-0032

Details and patient eligibility

About

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

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

50 to 70 years old

Volunteers

Accepts Healthy Volunteers

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