An interventional study of blood flow restriction and physical therapy standard of care in Anterior Cruciate Ligament Injuries, sponsored by University of Arkansas. Terminated at 1 site in United States. Open to participants aged 18 Years to 34 Years. Per ClinicalTrials.gov, last updated 2024-10-09.
Sponsored by University of Arkansas · Not applicable, Interventional, and Treatment
This will be a randomized pilot study to determine the effectiveness of Personalized Blood Flow Restriction (PBFR) technique in conjunction with prescribed physical therapy (PT) in a cohort of anterior cruciate ligament (ACL) reconstruction subjects
This will be a randomized pilot study to determine the effectiveness of Personalized Blood Flow Restriction (PBFR) technique in conjunction with prescribed physical therapy (PT) in a cohort of anterior cruciate ligament (ACL) reconstruction subjects. Both groups of subjects will undergo unilateral ACL reconstruction at University of Arkansas for Medical Sciences (UAMS), followed by prescribed PT at the UAMS Orthopedic Clinic at Colonel Glenn.
Up to 25 subjects will be enrolled. Half are randomized to the BFR group with the other will perform PT without BFR.
Data collection will occur at four approximate occasions: pre-surgery, 8-weeks postop, 12-weeks postop, and 16-weeks postop.
512 studies on the registry are indexed under Anterior Cruciate Ligament Injuries; 164 are open to participants now.
This study's enrollment of 2 is below the median of 56 across 373 interventional studies indexed under Anterior Cruciate Ligament Injuries.
Browse Anterior Cruciate Ligament Injuries studies →University of Arkansas is the lead sponsor of 391 studies on the registry; 39 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 34 (92%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other: blood flow restriction
Standard of care.
Other: physical therapy standard of care
Blood flow to the legs will be mostly restricted temporarily during physical therapy exercises for the initial several weeks of physical therapy.
the current standard of care after surgery for ACL repair.
Maximal Voluntary Contraction
Max torque produced in newton meter per second during an isometric contraction
Time frame: 16-weeks post-surgery
ACL Repair Range of Motion
Measured at the knee, therefore, the degree to which the lower limb can move around knee joint in relation to the upper limb.
Time frame: from enrollment to the end of treatment at 16 weeks
| Milestone | Physical Therapy With Blood Flow Restriction | Physical Therapy Without Blood Flow Restriction |
|---|---|---|
| Started | 1 | 1 |
| Completed | 0 | 0 |
| Not completed | 1 | 1 |
| Withdrew: Withdrawal by subject | 1 | 1 |
Max torque produced in newton meter per second during an isometric contraction
No measurements were reported for this outcome.
Measured at the knee, therefore, the degree to which the lower limb can move around knee joint in relation to the upper limb.
No measurements were reported for this outcome.
Collected over 20 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Physical Therapy With Blood Flow Restriction | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| Physical Therapy Without Blood Flow Restriction | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| Age, Categorical(Participants) | Physical Therapy With Blood Flow Restriction | Physical Therapy Without Blood Flow Restriction | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 1 | 1 | 2 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Physical Therapy With Blood Flow Restriction | Physical Therapy Without Blood Flow Restriction | Total |
|---|---|---|---|
| Female | 1 | 1 | 2 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Physical Therapy With Blood Flow Restriction | Physical Therapy Without Blood Flow Restriction | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 1 | 1 | 2 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Physical Therapy With Blood Flow Restriction | Physical Therapy Without Blood Flow Restriction | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 1 |
| White | 0 | 1 | 1 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Physical Therapy With Blood Flow Restriction | Physical Therapy Without Blood Flow Restriction | Total |
|---|---|---|---|
| United States | 1 | 1 | 2 |
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Plan to share: No
This study is terminated, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Anterior Cruciate Ligament Injuries→
University of Arkansas