Clinical trial NCT06516900: Reducing Foot Pain and Peak Plantar Pressure in Patients With Foot Pain
Official title: A Comparison of the Effectiveness of OrthoFeet HandsFree Therapeutic Shoes in Reducing Foot Pain and Peak Plantar Pressure
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Foot Pain
Lead sponsor: University of Texas Rio Grande Valley
Sponsor class: OTHER
First posted: 2024-07-24
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Foot pain
timeFrame: Baseline, 6 weeks, 12 weeks
measure: In-shoe Peak Plantar pressure
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Pressure-Time Integral
timeFrame: Baseline, 6 weeks, 12 weeks
Secondary outcomes:
measure: Quality of life
timeFrame: Baseline, 6 weeks, 12 weeks
measure: Physical activity
timeFrame: Baseline, 6 weeks, 12 weeks
Other outcomes:
Locations:
city: Harlingen
country: United States
facility: Hafizur Rahman
state: Texas
Study officials:
References: