Ankle osteoarthritis patients for Ankle

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Ankle+2 More
Standard walking shoe - Device
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial will test whether rocker bottom shoes and ankle-foot orthoses improve mobility in people with ankle osteoarthritis by relieving pain and reducing joint range of motion.

Eligible Conditions
  • Ankle
  • Healthy Ankles

Treatment Effectiveness

Study Objectives

1 Primary · 11 Secondary · Reporting Duration: Three Months

Three Months
Qualitative assessment of device preference
Three weeks
Ankle joint range of motion (degrees)
Daily step count (# steps)
Fast walking speed
Foot and ankle Mobility measure FAAM
Numeric Pain Rating Scale
PROMIS pain interference
Qualitative assessment of patient device wearing
Qualitative assessment of patient satisfaction with the device
Self-selected walking speed
Timed-up-and-go
three weeks
PROMIS physical function

Trial Safety

Trial Design

1 Treatment Group

Ankle osteoarthritis patients
1 of 1

Active Control

11 Total Participants · 1 Treatment Group

Primary Treatment: Ankle osteoarthritis patients · No Placebo Group · N/A

Ankle osteoarthritis patientsActiveComparator Group · 3 Interventions: Standard walking shoe, Rocker bottom shoe, Ankle foot orthosis · Intervention Types: Device, Device, Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: three months

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,474 Previous Clinical Trials
2,741,683 Total Patients Enrolled
Bruce J. Sangeorzan, MDPrincipal InvestigatorVA Puget Sound Health Care System Seattle Division, Seattle, WA
1 Previous Clinical Trials
368 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Radiographic evidence of tibiotalar osteoarthritis.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 14th, 2021

Last Reviewed: November 30th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.