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Step Promotion for Osteoarthritis (STOP Trial)

N/A
Recruiting
Led By Caroline Lisee, PhD
Research Sponsored by University of Georgia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Demonstrate < 7,000 steps per day during the screening phase of aim 2 as assessed using the Actigraph Link monitor
Completed all other formal physical therapy and therapeutic exercise regimens, and will not be engaging in any other formal therapy for their ACLR during the study
Must not have
History of seizures
The participant has previously been diagnosed with any diseases that affect joints is present in either knee including knee osteoarthritis inflammatory arthritis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-intervention (baseline), post-intervention (~18 weeks)
Awards & highlights

Summary

This trial aims to understand how the amount of daily steps taken after knee surgery affects the health of the cartilage in the knee joint. After knee surgery, people tend to take fewer steps, which may

Who is the study for?
This trial is for individuals who had ACL reconstruction surgery 6-24 months ago, are finished with physical therapy, can do unrestricted activities, and take fewer than 7,000 steps daily. They must own a smartphone and not plan to start any new knee therapies during the study. It's not for those with previous ACL graft injuries or other joint diseases in the knees, pregnant women or those planning pregnancy soon, people with BMI ≥ 36 kg/m2, non-English speakers, or certain medical conditions.
What is being tested?
The study aims to understand how daily walking affects knee cartilage health after ACL surgery by using MRI scans. Participants will track their steps to see if low activity levels lead to weaker cartilage. The hypothesis is that fewer daily steps result in poorer knee cartilage condition.
What are the potential side effects?
Since this intervention involves promoting increased daily step counts rather than medication or invasive procedures, significant side effects are not anticipated. However, participants may experience discomfort or fatigue from increased physical activity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I walk less than 7,000 steps a day as tracked by an activity monitor.
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I have finished all physical therapy for my ACL repair and won't start any new therapy during the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had seizures in the past.
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I have been diagnosed with a joint disease, such as arthritis, in my knee.
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I need surgery for multiple ligament injuries including my ACL.
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I broke a leg bone when I injured my ACL.
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I cannot speak English.
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I had surgery to fix a previous ACL graft injury.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-intervention (baseline)
This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-intervention (baseline) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Average cartilage strain in the lateral femoral condyle
Average cartilage strain in the lateral tibial condyle
Average cartilage strain in the medial femoral condyle
+14 more
Other outcome measures
Change in Knee Injury and Osteoarthritis Outcome Score Quality of Life subscale
Change in daily steps

Trial Design

1Treatment groups
Experimental Treatment
Group I: Interventional GroupExperimental Treatment1 Intervention
Participants who meet study criteria and are enrolled in adaptive daily step promotion intervention

Find a Location

Who is running the clinical trial?

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH
493 Previous Clinical Trials
1,089,374 Total Patients Enrolled
5 Trials studying Anterior Cruciate Ligament Injury
1,424 Patients Enrolled for Anterior Cruciate Ligament Injury
University of GeorgiaLead Sponsor
102 Previous Clinical Trials
44,692 Total Patients Enrolled
Caroline Lisee, PhDPrincipal InvestigatorUniversity of Georgia
~37 spots leftby Jan 2028
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