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Vibration Therapy for Osteoarthritis after ACL Injury

N/A
Recruiting
Led By Troy Blackburn, PhD
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 16 to 35 years
Unilateral, primary ACLR with bone-patellar tendon-bone autograft
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months post acl reconstruction surgery
Awards & highlights

Study Summary

This trial is evaluating the effect of vibration on quadriceps function, gait biomechanics, patient self-report outcomes, cartilage composition, and PTOA incidence in patients who have had ACL surgery.

Who is the study for?
This trial is for individuals aged 16-35 who've had a specific knee surgery (ACLR) using their own tissue. They must not have had previous ACL injuries, other knee surgeries, recent leg injuries besides the primary ACL injury, diagnosed arthritis in lower joints, neurological disorders, MRI contraindications like metal implants or severe claustrophobia, or be pregnant.Check my eligibility
What is being tested?
The study tests if adding vibration to standard rehab after ACL surgery can improve outcomes. Participants are randomly placed into three groups: one with regular rehab exercises; another adds whole body vibration; and the last uses local muscle vibration. Their muscle function, gait, joint health via MRI and risk of re-injury will be monitored over a year.See study design
What are the potential side effects?
While not explicitly stated in this summary, potential side effects from participating could include discomfort from vibrations during treatment sessions and possible aggravation of existing conditions due to physical therapy activities.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You are between 16 and 35 years old.
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You had surgery to fix your ACL using a specific type of tendon from your own body.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months post acl reconstruction surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months post acl reconstruction surgery 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 KOOS Knee-related Quality of Life Subscale over the first 12 months following ACL reconstruction surgery
Change in T1rho relaxation time (medial femoral condyle) over the first 12 months following ACL reconstruction surgery
Knee Replacement Arthroplasty (procedure)
+5 more
Secondary outcome measures
Change in ACL-QOL total score over the first 12 months following ACL reconstruction surgery
Change in IKDC total score over the first 12 months following ACL reconstruction surgery
Change in KOOS total score over the first 12 months following ACL reconstruction surgery
+29 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Whole Body VibrationExperimental Treatment1 Intervention
Patients will perform standard rehabilitation for the first month post-ACLR. At 1 month they will continue with standard rehabilitation, but will also be exposed to whole body vibration at the beginning of each session prior to rehabilitation exercises in an effort to enhance their efficacy.
Group II: Local Muscle VibrationExperimental Treatment1 Intervention
Patients will perform standard rehabilitation for the first month post-ACLR. At 1 month they will continue with standard rehabilitation, but will also be exposed to local muscle vibration at the beginning of each session prior to rehabilitation exercises in an effort to enhance their efficacy.
Group III: Standard ACL RehabilitationActive Control1 Intervention
Patients will complete a 20-week supervised, progressive rehabilitation protocol directed by physical therapists at 1 of 3 participating clinics. While the specific rehabilitation exercises and techniques used for a given patient may vary depending on clinician preference/experience and patient responsiveness and progress, the general rehabilitation protocol will be standardized and follow current best practices emphasizing restoration of early weight bearing, range of motion, quadriceps function, balance, and neuromuscular control consistent with the Multicenter Orthopaedics Outcomes Network (MOON) rehabilitation protocol.

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor
1,498 Previous Clinical Trials
4,176,098 Total Patients Enrolled
2 Trials studying Anterior Cruciate Ligament Injury
177 Patients Enrolled for Anterior Cruciate Ligament Injury
Womack Army Medical CenterFED
18 Previous Clinical Trials
16,181 Total Patients Enrolled
Troy Blackburn, PhDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
1 Previous Clinical Trials
75 Total Patients Enrolled

Media Library

Standard ACL Rehabilitation Clinical Trial Eligibility Overview. Trial Name: NCT04875052 — N/A
Anterior Cruciate Ligament Injury Research Study Groups: Standard ACL Rehabilitation, Whole Body Vibration, Local Muscle Vibration
Anterior Cruciate Ligament Injury Clinical Trial 2023: Standard ACL Rehabilitation Highlights & Side Effects. Trial Name: NCT04875052 — N/A
Standard ACL Rehabilitation 2023 Treatment Timeline for Medical Study. Trial Name: NCT04875052 — N/A

Frequently Asked Questions

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

Are minors eligible for this clinical trial?

"The age bracket for this trial is 16-35."

Answered by AI

How do I qualify to be a subject in this research?

"This study is looking for 114 participants that have torn their anterior cruciate ligament and meet the following qualifications: Unilateral, primary ACLR with bone-patellar tendon-bone autograft, Age 16 to 35 years."

Answered by AI

Are there any patients who are not yet enrolled in this trial?

"That is correct. The website clinicaltrials.gov has the latest information on this trial. According to the site, the trial was first posted on 1/11/2021 and was last edited on 10/11/2022. The trial is currently enrolling 114 participants at 2 sites."

Answered by AI

By what means does this research hope to achieve its objective?

"The aim of this study is to observe changes in peak internal knee extension moment during walking in patients within 12 months of ACL reconstruction surgery. This will be done by measuring three-dimensional kinematics and kinetics during double-leg landings, via a 10-camera motion capture system interfaced with embedded force plates. Peak knee flexion angle will be identified during the loading phase of landing (initial ground contact to peak knee flexion), and change scores will be calculated from Baseline (1 month) to 6 months and Baseline to 12 months to be used as dependent variables."

Answered by AI

Who else is applying?

What state do they live in?
Vermont
Pennsylvania
North Carolina
How old are they?
18 - 65
What site did they apply to?
MOTION Science Institute
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria

How responsive is this trial?

Average response time
  • < 1 Day
Most responsive sites:
  1. MOTION Science Institute: < 24 hours
Typically responds via
Email
~27 spots leftby Mar 2025