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Physical therapy for Anterior Cruciate Ligament Reconstruction

N/A
Recruiting
Led By Walter R Lowe, MD
Research Sponsored by The University of Texas Health Science Center, Houston
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 2 months after start of pt
Awards & highlights

Study Summary

This trial will compare the effectiveness of physical therapy with and without BFR training in patients who require extended limited weight bearing after ACL reconstruction. The hypothesis is that PT plus BFR training will improve quadriceps muscle cross-sectional area, strength, and function while also improving early clinical and functional results.

Eligible Conditions
  • Anterior Cruciate Ligament Reconstruction
  • Quadriceps Atrophy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at start of pt, 2 months after start of pt
This trial's timeline: 3 weeks for screening, Varies for treatment, and at start of pt, 2 months after start of pt 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 Quadriceps Muscle Cross-Sectional Area (CSA) as Assessed by Ultrasound
Secondary outcome measures
Change in Active Range of Motion as Assessed by the Straight-Leg-Raise Test
Change in Activity as Assessed by Patient-Reported Score on the Marx Scale
Change in Activity as Assessed by Patient-Reported Score on the Tegner Activity Scale
+15 more

Side effects data

From 2011 Phase 4 trial • 127 Patients • NCT01250184
10%
Hematomas
100%
80%
60%
40%
20%
0%
Study treatment Arm
Lidocaine Injection + Physical Therapy
Physical Therapy
Lidocaine Injection

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Physical therapy (PT) plus blood flow restriction (BFR)Experimental Treatment2 Interventions
Physical therapy consists of two or three 90-minute sessions per week for 6 weeks and a minimum of 18 visits required for study inclusion. With BFR, exercises will be performed at 30% one-rep max with the BFR cuff placed around the proximal thigh and inflated to 80% of limb occlusion pressure (avg: 150 mmHg).
Group II: Physical therapyActive Control1 Intervention
Physical therapy consists of two or three 90-minute sessions per week for 6 weeks and a minimum of 18 visits required for study inclusion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Blood flow restriction
2019
Completed Phase 2
~190

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor
903 Previous Clinical Trials
320,827 Total Patients Enrolled
Memorial Hermann HospitalOTHER
16 Previous Clinical Trials
56,125 Total Patients Enrolled
Walter R Lowe, MD4.023 ReviewsPrincipal Investigator - The University of Texas Health Science Center, Houston
The University of Texas Health Science Center, Houston
1 Previous Clinical Trials
1Patient Review
This surgeon did a terrible job on my shoulder. I went in for a labrum tear and he inserted two screws that came out. I developed a large bone spur and scapular winding. I'm now facing a total shoulder replacement.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Does Blood Flow Restriction Training Improve Quadriceps Function After Arthroscopic Knee Surgery?
Walter R Lowe 2017. "Does Blood Flow Restriction Training Improve Quadriceps Function After Arthroscopic Knee Surgery?". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03096366.
~20 spots leftby Apr 2025
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