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Behavioural Intervention

Foot Rehab + Minimalist Shoes for Plantar Fasciitis (FRAMES Trial)

N/A

Recruiting

Led By Susan Saliba, PhD

Research Sponsored by University of Virginia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Between ages of 18 - 55 years old

First-step pain in the morning over past week - Visual Analog Score between 30-70 mm

Must not have

Other current lower extremity neuromusculoskeletal injury

Previous history of foot/ankle fractures or surgeries

Timeline

Screening 3 weeks

Treatment Varies

Follow Up this outcome change will be measured from baseline, to the midpoint of the intervention (4 weeks), to the end of the intervention (8 weeks) for both groups.

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare the effects of doing foot rehab exercises and wearing minimalist shoes to just doing foot rehab exercises for reducing pain, improving function, increasing muscle strength, and improving balance and gait.

Who is the study for?

Adults aged 18-55 with plantar fasciopathy, experiencing morning heel pain for at least a month are eligible. They must have moderate pain levels and no other lower extremity injuries or surgeries in recent history. Those already in rehab for this condition or with prior minimalist shoe experience cannot participate.

What is being tested?

The trial is testing if foot rehabilitation exercises combined with wearing minimalist shoes over 8 weeks can reduce pain and improve function, strength, balance, and gait in adults with plantar fasciopathy better than exercises alone.

What are the potential side effects?

Potential side effects may include discomfort from new exercise routines or adapting to minimalist shoes which could lead to temporary increases in foot pain or soreness as the body adjusts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 55 years old.

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My morning pain level is moderate, not mild or severe.

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I have had heel pain for over a month that started gradually.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a current injury to my leg's muscles, bones, or nerves.

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I have had foot or ankle fractures or surgeries in the past.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ this outcome change will be measured from baseline, to the midpoint of the intervention (4 weeks), to the end of the intervention (8 weeks) for both groups.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~this outcome change will be measured from baseline, to the midpoint of the intervention (4 weeks), to the end of the intervention (8 weeks) for both groups.

This trial's timeline: 3 weeks for screening, Varies for treatment, and this outcome change will be measured from baseline, to the midpoint of the intervention (4 weeks), to the end of the intervention (8 weeks) for both groups. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Pain

Change in center of pressure (COP) 95% ellipse area during balance

Change in center of pressure (COP) distance during balance

+8 more

Secondary study objectives

Change in activity level

Change in activity level per day

Change in ankle sagittal plane kinematics

+11 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Foot Rehabilitation And Minimalist Shoes (FRAMES)Experimental Treatment2 Interventions

The intervention group will receive a pair of minimalist shoes along with a home exercise program and a protocol that indicates how to slowly adjust to wearing the shoes.

Group II: Home Exercise Program (Control)Active Control1 Intervention

The intervention group will receive a home exercise program.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Home Exercise Program

2019

Completed Phase 3

~810

0 / 5Eligibility criteria met