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NCT03141801 · ClinicalTrials.gov registry record · NA
Blood Flow Restriction to Improve Muscle Strength After ACL Injury
A NA study of Anterior Cruciate Ligament Injury, sponsored by University of Michigan.
- Completed
- Registry status
- NA
- Development phase
- 48
- Enrollment target
- 1
- Study location
NCT03141801: Completed NA study of Anterior Cruciate Ligament Injury, sponsored by University of Michigan.
NCT03141801 is a NA study of Anterior Cruciate Ligament Injury that has completed, run by University of Michigan. The registered enrollment target is 48 participants, below the 228-participant average among 8 other Anterior Cruciate Ligament Injury trials with a reported enrollment target (79% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03141801, a NA study of Anterior Cruciate Ligament Injury, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- NA
- Development phase
- 48 participants
- Enrollment target
- 1
- Study location
Study Summary
Quadriceps muscle weakness is a common consequence following anterior cruciate ligament (ACL) injury and reconstruction. Maximizing quadriceps strength following ACL injury is significant as diminished quadriceps strength has been linked to the osteoarthritis that affects over 50% of surgically reconstructed limbs. Given that knee joint health following ACL injury is predicated on restoring quadriceps strength, identifying treatment approaches capable of improving strength is paramount. Blood flow restriction training (BFRT) is a method where oxygen to the muscle is intentionally reduced during exercise/rehabilitation and may lead to more timely and substantial strength gains. In the proposed project, we will examine the efficacy of BFRT in patients who have undergone ACL reconstruction and suffer from substantial quadriceps weakness.
Primary Outcome
concentric isokinetic muscle strength at 60 degrees per second
Conditions Studied
Interventions
- DEVICE DELFI PTS Personalized Tourniquet System for Blood Flow Restriction Training
- OTHER Eccentric Exercise with BLAST Leg Press System
- OTHER Concentric Exercise with BLAST Leg Press System
Study Locations (1)
Michigan
- University of Michigan - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2016-08-25 |
| Est. Completion | 2018-11-21 |
| Phase | NA |
What the finished NCT03141801 record still lists
NCT03141801 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 228-participant average among 8 other Anterior Cruciate Ligament Injury trials with a reported enrollment target (79% lower).
The record links to 1 condition, with Anterior Cruciate Ligament Injury appearing as the primary indexed condition, and to 3 interventions - of which DELFI PTS Personalized Tourniquet System for Blood Flow Restriction Training is the first listed.
NCT03141801 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT03141801 about?
NCT03141801 is a clinical study titled "Blood Flow Restriction to Improve Muscle Strength After ACL Injury". Quadriceps muscle weakness is a common consequence following anterior cruciate ligament (ACL) injury and reconstruction. Maximizing quadriceps strength following ACL injury is significant as diminished quadriceps strength has been linked to the osteoarthritis that affects over 50% of surgically reco...
What is the current status of trial NCT03141801?
This trial is currently completed. It is a NA study. The enrollment target is 48 participants. The study started on 2016-08-25. Estimated completion is 2018-11-21.
What conditions does trial NCT03141801 study?
This clinical trial studies the following conditions: Anterior Cruciate Ligament Injury.
What interventions are being tested in trial NCT03141801?
The interventions under investigation include: DELFI PTS Personalized Tourniquet System for Blood Flow Restriction Training (DEVICE), Eccentric Exercise with BLAST Leg Press System (OTHER), Concentric Exercise with BLAST Leg Press System (OTHER).
Who is sponsoring clinical trial NCT03141801?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03141801 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03141801's enrollment target sits among peer trials
48 5th of 8 higher than 3 of 8 other Anterior Cruciate Ligament Injury trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anterior Cruciate Ligament Injury trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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