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Arm A - blood flow restriction training for Anterior Cruciate Ligament Injury/Tear

N/A

Waitlist Available

Led By Brian Noehren, PT., Ph.D

Research Sponsored by Brian W. Noehren

Eligibility Criteria Checklist

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

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up before surgery, 4 months after surgery and 6 months after surgery

Awards & highlights

Study Summary

This trial will compare two different blood flow restriction training programs to see if one improves leg strength and function more than the other in conjunction with standard rehabilitation for those who will or have had ACL reconstruction. There will be no charge to the participant for their physical therapy visits.

Eligible Conditions

Anterior Cruciate Ligament (ACL) Injury/Tear
Physical Therapy

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ before surgery, 4 months after surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~before surgery, 4 months after surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and before surgery, 4 months after 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

Measure change in quadriceps strength after using BFRT for treatment in patients who will have an ACL reconstruction.

Secondary outcome measures

Measure change in knee biomechanics after using BFRT for treatment in patients who will have an ACL reconstruction.

Measure change in quadriceps muscle morphology after using BFRT for treatment in patients who will have an ACL reconstruction.

Other outcome measures

Measure the change in muscle physiology after using BFRT for treatment in patients who will have an ACL reconstruction.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm A - Blood flow restriction trainingExperimental Treatment1 Intervention

Group will use blood flow restriction training and standard of care

Group II: Arm B - standard of care plus shamPlacebo Group1 Intervention

Group will receive standard of care plus a sham version of blood flow restriction training

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH

483 Previous Clinical Trials

1,086,884 Total Patients Enrolled

Brian W. NoehrenLead Sponsor

1 Previous Clinical Trials

60 Total Patients Enrolled

Brian Noehren, PT., Ph.DPrincipal InvestigatorUniversity of Kentucky

Media Library

Arm A - blood flow restriction training (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03364647 — N/A

Anterior Cruciate Ligament Injury/Tear Research Study Groups: Arm A - Blood flow restriction training, Arm B - standard of care plus sham

Anterior Cruciate Ligament Injury/Tear Clinical Trial 2023: Arm A - blood flow restriction training Highlights & Side Effects. Trial Name: NCT03364647 — N/A

Arm A - blood flow restriction training (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03364647 — N/A

Frequently Asked Questions

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

To what extent is the patient cohort being evaluated in this clinical experiment?

"Confirmed, this clinical trial is still recruiting with 60 patients sought from two medical centres. The study was initially posted on August 21st 2017 and has been actively updated up to October 27th 2022 according to the data hosted at clinicaltrials.gov."

Answered by AI

Is this research open to individuals aged 60 and over?

"The trial parameters restrict enrolment to those between 15 and 40 years of age. Conversely, there are 5 studies that can be accessed by minors and 13 trials for patients over the retirement threshold."

Answered by AI

Are there any vacancies available for prospective participants in this research project?

"Affirmative, the information located on clinicaltrials.gov implies that this experiment is presently recruiting participants. The original posting date was August 21st 2017 and it has been recently modified on October 27th 2022. This study requires 60 patients to come from two different sites for enrollment."

Answered by AI

Is this clinical trial open to all eligible individuals?

"The protocol for this study necessitates the enrollment of 60 participants aged between 15 and 40, all currently receiving physical therapy. Additionally, to qualify, patients must have an anterior cruciate ligament tear in their involved limb without any prior ACL reconstruction on either side."

Answered by AI

Recent research and studies

Physical TherapyJournal

Effect of Blood Flow Restriction Training on Quadriceps Muscle Strength, Morphology, Physiology, and Knee Biomechanics Before and After Anterior Cruciate Ligament Reconstruction: Protocol for a Randomized Clinical Trial

Erickson, Lauren N, Kathryn C Hickey Lucas, Kylie A Davis, Cale A Jacobs, Katherine L Thompson, Peter A Hardy, Anders H Andersen, Christopher S Fry, and Brian W Noehren. 2019. “Effect of Blood Flow Restriction Training on Quadriceps Muscle Strength, Morphology, Physiology, and Knee Biomechanics Before and After Anterior Cruciate Ligament Reconstruction: Protocol for a Randomized Clinical Trial”. Physical Therapy. Oxford University Press (OUP). doi:10.1093/ptj/pzz062.

Physical TherapyJournal

clinicaltrials.govStudy

The Effect of Various Strength Training Protocols in ACL Reconstructed Participants

Brian W. Noehren 2017. "The Effect of Various Strength Training Protocols in ACL Reconstructed Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03364647.