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Difficulty recruiting subjects; funding not renewed.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| physical therapy with blood flow restriction | Experimental |
| |
| physical therapy without blood flow restriction | Other | Standard of care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| blood flow restriction | Other | Blood flow to the legs will be mostly restricted temporarily during physical therapy exercises for the initial several weeks of physical therapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximal Voluntary Contraction | Max torque produced in newton meter per second during an isometric contraction | 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. | from enrollment to the end of treatment at 16 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arny A Ferrando, Ph.D. | University of Arkansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAMS Center on Aging | Little Rock | Arkansas | 72205 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Physical Therapy Without Blood Flow Restriction | Standard of care. physical therapy standard of care: the current standard of care after surgery for ACL repair. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Physical Therapy Without Blood Flow Restriction |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximal Voluntary Contraction | Max torque produced in newton meter per second during an isometric contraction | 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. | Posted | 16-weeks post-surgery |
|
20 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Arny A. Ferrando | UAMS | 501-526-5711 | AFerrando@uams.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 3, 2022 | Jul 5, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000070598 | Anterior Cruciate Ligament Injuries |
| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D000090003 | Blood Flow Restriction Therapy |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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| physical therapy standard of care | Other | the current standard of care after surgery for ACL repair. |
|
Standard of care. physical therapy standard of care: the current standard of care after surgery for ACL repair. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Standard of care.
physical therapy standard of care: the current standard of care after surgery for ACL repair.
|
| Primary | 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. | No participant completed this measure. | Posted | from enrollment to the end of treatment at 16 weeks |
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | Physical Therapy Without Blood Flow Restriction | Standard of care. physical therapy standard of care: the current standard of care after surgery for ACL repair. | 0 | 1 | 0 | 1 | 0 | 1 |
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| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |