Recruiting
Phase 2

Plantar Fasciitis

Sponsor:

University of South Florida

Code:

NCT05834491

Conditions

Plantar Fasciitis, Chronic

Eligibility Criteria

Sex: All

Age: 50 - 70

Healthy Volunteers: Not accepted

Interventions

minimal shoes and foot strengthening and flexibility exercises

Supportive Footwear, foot orthotic device and foot flexibility exercises

Study Details

Brief summary:

The goal of this study is to determine whether improving foot strength through foot exercises and minimal footwear can provide improved outcomes over the short and long term. The main research question it aims to answer is: Can the minimal footwear intervention be used to improve the health of aging adults with plantar fasciitis?? Participants will be randomized into 2 groups. One group will receive minimal shoes and foot strengthening and foot flexibility exercises. The other group will receive supportive shoes, foot orthotic device and foot flexibility exercises. Participants' step count will also be monitored.

Researchers will compare pain and physical function between the minimal footwear (MF) and the foot orthotic (FO) groups at each of the follow-up sessions.

Conditions

Plantar Fasciitis, Chronic

Study ID

NCT05834491

Start date

Aug 7, 2023

Status verified date

May, 2024

Completion date

May 31, 2025

Anticipated

Primary completion date

May 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

1 Active plantar fasciitis for a minimum of 6 months. 2. Heel/arch pain on first step in the morning, 3. Heel/arch pain with prolonged standing (>15 min), 4. Heel/arch pain with prolonged walking (>15 min), 5. Be able to stand and walk for 10 minutes with little or no pain (<3/10 on a NRPS).

Exclusion Criteria:

1. Having systemic disease such as diabetes, gout, arthritis, neuropathy, surgical reconstructions
2. Having a history of heel surgery or had a steroid injection for heel pain in the past 6 months.
3. Used foot orthoses less than 3 months before start date of study.
4. Having used minimal shoes at any time in the past.
5. No special or vulnerable populations will be recruited.

Study Design

Enrollment

138 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Minimal Footwear (Vivobarefoot)

The experimental intervention involves the combination of foot strengthening/stretching and minimal footwear to promote the foot strengthening beyond the exercise program to mitigate weakening from chronic support.

active comparator: Supportive Footwear

The control intervention is considered the standard of care and involves combination of foot stretching and the addition of supportive shoes and foot orthoses.

Interventions

minimal shoes and foot strengthening and flexibility exercises

Flexible shoes that do not provide support and exercises aimed at increasing the strength of plantar intrinsic and extrinsic foot muscles along with foot flexibility exercises aimed at increasing the range of motion of the foot and ankle

Supportive Footwear, foot orthotic device and foot flexibility exercises

sturdy supportive shoes fitted with supportive foot orthotic devices and foot flexibility exercises aimed at increasing the range of motion of the foot and ankle

Primary outcome measure

  • Foot Health Status Questionnaire (FHSQ) [ Time Frame: Baseline ]
  • Foot Health Status Questionnaire (FHSQ) [ Time Frame: 3 months ]
  • Foot Health Status Questionnaire (FHSQ) [ Time Frame: 6 months ]
  • Foot pain [ Time Frame: Baseline ]
  • Foot pain [ Time Frame: 1 month ]
  • Foot pain [ Time Frame: 2 months ]
  • Foot pain [ Time Frame: 3 months ]
  • Foot pain [ Time Frame: 4 months ]
  • Foot pain [ Time Frame: 5 months ]
  • Foot pain [ Time Frame: 6 months ]
  • Foot pain [ Time Frame: 7 months ]
  • Foot pain [ Time Frame: 8 months ]
  • Foot pain [ Time Frame: 9 months ]
  • Foot pain [ Time Frame: 10 months ]
  • Foot pain [ Time Frame: 11 months ]
  • Foot pain [ Time Frame: 12 months ]
  • Step counts [ Time Frame: Baseline ]
  • Step counts [ Time Frame: 1 month ]
  • Step counts [ Time Frame: 2 months ]
  • Step counts [ Time Frame: 3 months ]
  • Step counts [ Time Frame: 4 months ]
  • Step counts [ Time Frame: 5 months ]
  • Step counts [ Time Frame: 6 months ]
  • Step counts [ Time Frame: 7 months ]
  • Step counts [ Time Frame: 8 months ]
  • Step counts [ Time Frame: 9 months ]
  • Step counts [ Time Frame: 10 months ]
  • Step counts [ Time Frame: 11 months ]
  • Step counts [ Time Frame: 12 months ]
  • Global Rating Outcome Change (GROC) [ Time Frame: 3 months ]
  • Global Rating Outcome Change (GROC) [ Time Frame: 6 months ]
  • Patient Acceptable Symptom State (PASS) [ Time Frame: 3 months ]
  • Patient Acceptable Symptom State (PASS) [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Irene Davis, PhD

3025596433sdavis@usf.edu

Locations

University of South Flroida

Recruiting

Tampa, Florida, United States, 33612

More Information

Sponsor

University of South Florida

Last update posted

May 21, 2024

Last verified

May, 2024

Keywords

  • minimal footwear, pain, function, strengthening

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of South Florida on 2024-05-21.