Health TrialsbyHealthPanel

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

ConditionFoot Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-70
SponsorUniversity of Texas Rio Grande Valley

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Own ShoeNo intervention 0 interventions
Group B: OrthoFeet shoeExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Foot pain

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).

Time frame
Baseline, 6 weeks, 12 weeks
2

In-shoe Peak Plantar pressure

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).

Time frame
Baseline, 6 weeks, 12 weeks
3

Pressure-Time Integral

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).

Time frame
Baseline, 6 weeks, 12 weeks

Secondary outcomes

1

Quality of life

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).

Time frame
Baseline, 6 weeks, 12 weeks
2

Physical activity

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.

Time frame
Baseline, 6 weeks, 12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Texas Rio Grande Valley

Lead sponsor

Source ClinicalTrials.gov
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