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Behavioural Intervention

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

N/A

Waitlist Available

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

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

FRAMES Trial 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.Check my eligibility

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.See study design

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.

FRAMES Trial 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.

FRAMES Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

Change in activity level

Change in activity level per day

Change in ankle sagittal plane kinematics

+11 more

FRAMES 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

~760

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of VirginiaLead Sponsor

753 Previous Clinical Trials

1,244,997 Total Patients Enrolled

Susan Saliba, PhDPrincipal InvestigatorUniversity of Virginia

Jennifer Xu, MSPrincipal InvestigatorUniversity of Virginia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Would I be eligible for enrollment in this clinical experiment?

"Qualified individuals must possess the diagnosis of plantar fasciitis and fall between 18-55 years old to be eligible for participation. The medical trial is enrolling a total of 34 participants."

Answered by AI

Is the enrollment process for this investigation still ongoing?

"Clinicaltrials.gov data confirms that this trial, first published on November 20th of 2023, is no longer recruiting participants. However, there are 27 other studies actively looking for individuals to enroll in them at the moment."

Answered by AI

Is this research project accommodating people aged 65 or above?

"The age requirements for this research are between 18 and 55 years of age, as indicated in the study's criteria."

Answered by AI

What is the purpose of this medical experiment?

"The objective of this experiment is to evaluate the change in individuals' self-reported well being over an 8 week period. Secondary endpoints include variations in fear avoidance beliefs as measured by FABQ scores, alterations in pain self efficacy determined by PSEQ results, and fluctuations in activity level assessed through NASA's Activity Survey (NAS)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Effects of Foot Rehabilitation And Minimalist Shoes on Pain, Strength, and Function in Adults With Plantar Fasciopathy

Jen Xu 2023. "Effects of Foot Rehabilitation And Minimalist Shoes on Pain, Strength, and Function in Adults With Plantar Fasciopathy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06106958.

All > Plantar Fasciitis