Trial Outcomes & Findings for Blood Flow Restriction Training in ACL Surgery (NCT NCT05245864)
NCT ID: NCT05245864
Last Updated: 2024-10-09
Results Overview
Max torque produced in newton meter per second during an isometric contraction
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
2 participants
Primary outcome timeframe
16-weeks post-surgery
Results posted on
2024-10-09
Participant Flow
Participant milestones
| Measure |
Physical Therapy With Blood Flow Restriction
blood flow restriction: Blood flow to the legs will be mostly restricted temporarily during physical therapy exercises for the initial several weeks of physical therapy.
|
Physical Therapy Without Blood Flow Restriction
Standard of care.
physical therapy standard of care: the current standard of care after surgery for ACL repair.
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Physical Therapy With Blood Flow Restriction
blood flow restriction: Blood flow to the legs will be mostly restricted temporarily during physical therapy exercises for the initial several weeks of physical therapy.
|
Physical Therapy Without Blood Flow Restriction
Standard of care.
physical therapy standard of care: the current standard of care after surgery for ACL repair.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Blood Flow Restriction Training in ACL Surgery
Baseline characteristics by cohort
| Measure |
Physical Therapy With Blood Flow Restriction
n=1 Participants
blood flow restriction: Blood flow to the legs will be mostly restricted temporarily during physical therapy exercises for the initial several weeks of physical therapy.
|
Physical Therapy Without Blood Flow Restriction
n=1 Participants
Standard of care.
physical therapy standard of care: the current standard of care after surgery for ACL repair.
|
Total
n=2 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 16-weeks post-surgeryPopulation: Participant who did Physical therapy without blood flow restriction completed only enrollment and pre testing. Participant who completed physical therapy with blood flow restriction completed only enrollment, pre testing, and one post operative testing visit.
Max torque produced in newton meter per second during an isometric contraction
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: from enrollment to the end of treatment at 16 weeksPopulation: No participant completed this measure.
Measured at the knee, therefore, the degree to which the lower limb can move around knee joint in relation to the upper limb.
Outcome measures
Outcome data not reported
Adverse Events
Physical Therapy With Blood Flow Restriction
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Physical Therapy Without Blood Flow Restriction
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place