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| Name | Class |
|---|---|
| Memorial Hermann Hospital | OTHER |
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The purpose of this study is to evaluate the effectiveness of physical therapy (PT) plus BFR training compared to PT alone (without BFR training) after ACL reconstruction in patients who require extended limited weight bearing through assessment of patient reported outcomes and functional testing. The hypothesis is that PT plus BFR training will mitigate the loss of quadriceps muscle cross-sectional area, strength, and function while also improving early clinical and functional results.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physical therapy (PT) plus blood flow restriction (BFR) | Experimental | 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). |
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| Physical therapy | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood flow restriction | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quadriceps Muscle Cross-Sectional Area (CSA) as Assessed by Ultrasound | Initiation of PT is 1 month after surgery | at start of PT, 1 month after start of PT |
| Change in Quadriceps Muscle Cross-Sectional Area (CSA) as Assessed by Ultrasound | Initiation of PT is 1 month after surgery | at start of PT, 2 months after start of PT |
| Change in Quadriceps Muscle Cross-Sectional Area (CSA) as Assessed by Ultrasound | Initiation of PT is 1 month after surgery | at start of PT, 5 months after start of PT |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Passive Range of Motion as Assessed by Goniometer | Initiation of PT is 1 month after surgery | at start of PT, 1 month after start of PT |
| Change in Passive Range of Motion as Assessed by Goniometer |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Walter R Lowe, MD | Contact | 713-486-6844 | walter.r.lowe@uth.tmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Walter R Lowe, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Recruiting | Houston | Texas | 77030 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 30, 2023 | Dec 15, 2023 | 6 |
| ID | Term |
|---|---|
| D000090003 | Blood Flow Restriction Therapy |
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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Blinding is not possible given the nature of the intervention.
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| Physical therapy | Other | 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. |
|
Initiation of PT is 1 month after surgery
| at start of PT, 2 months after start of PT |
| Change in Passive Range of Motion as Assessed by Goniometer | Initiation of PT is 1 month after surgery | at start of PT, 5 months after start of PT |
| Change in Active Range of Motion as Assessed by the Straight-Leg-Raise Test | The uninvolved knee is bent 90 degrees as determined by a standard goniometer. The patient/participant is asked to raise the involved limb to the height of the tibial tuberosity of the uninvolved limb. Initiation of PT is 1 month after surgery. | at start of PT, 1 month after start of PT |
| Change in Active Range of Motion as Assessed by the Straight-Leg-Raise Test | The uninvolved knee is bent 90 degrees as determined by a standard goniometer. The patient/participant is asked to raise the involved limb to the height of the tibial tuberosity of the uninvolved limb.Initiation of PT is 1 month after surgery. | at start of PT, 2 months after start of PT |
| Change in Active Range of Motion as Assessed by the Straight-Leg-Raise Test | The uninvolved knee is bent 90 degrees as determined by a standard goniometer. The patient/participant is asked to raise the involved limb to the height of the tibial tuberosity of the uninvolved limb.Initiation of PT is 1 month after surgery. | at start of PT, 5 months after start of PT |
| Isometric quadriceps strength as Assessed by Dynamometer | Initiation of PT is 1 month after surgery. | 1 month after start of PT |
| Isometric quadriceps strength as Assessed by Dynamometer | Initiation of PT is 1 month after surgery. | 2 months after start of PT |
| Isokinetic quadriceps strength as Assessed by Dynamometer | Initiation of PT is 1 month after surgery. | 5 months after start of PT |
| Change in Thigh circumference (proximal, mid, distal) as Assessed by Measuring tape | Initiation of PT is 1 month after surgery. | at start of PT, 1 month after start of PT |
| Change in Thigh circumference (proximal, mid, distal) as Assessed by Measuring tape | Initiation of PT is 1 month after surgery. | at start of PT, 2 months after start of PT |
| Change in Thigh circumference (proximal, mid, distal) as Assessed by Measuring tape | Initiation of PT is 1 month after surgery. | at start of PT, 5 months after start of PT |
| Functional Performance as Assessed by Balance Error Scoring System | Initiation of PT is 1 month after surgery. | 2 months after start of PT |
| Functional Performance as Assessed by Balance Error Scoring System | Initiation of PT is 1 month after surgery. | 5 months after start of PT |
| Functional Performance as Assessed by Overhead Squat Test | Initiation of PT is 1 month after surgery. | 2 months after start of PT |
| Functional Performance as Assessed by Overhead Squat Test | Initiation of PT is 1 month after surgery. | 5 months after start of PT |
| Functional Performance as Assessed by Y-Balance Test | Initiation of PT is 1 month after surgery. | 2 months after start of PT |
| Functional Performance as Assessed by Y-Balance Test | Initiation of PT is 1 month after surgery. | 5 months after start of PT |
| Functional Performance as Assessed by Single-Leg Squat Assessment | Initiation of PT is 1 month after surgery. | 2 months after start of PT |
| Functional Performance as Assessed by Single-Leg Squat Assessment | Initiation of PT is 1 month after surgery. | 5 months after start of PT |
| Functional Performance as Assessed by Vail Sport Test | Initiation of PT is 1 month after surgery. | 2 months after start of PT |
| Functional Performance as Assessed by Vail Sport Test | Initiation of PT is 1 month after surgery. | 5 months after start of PT |
| Functional Performance as Assessed by Landing Error Scoring System | Initiation of PT is 1 month after surgery. | 2 months after start of PT |
| Functional Performance as Assessed by Landing Error Scoring System | Initiation of PT is 1 month after surgery. | 5 months after start of PT |
| Functional Performance as Assessed by Single leg Hop Testing | Initiation of PT is 1 month after surgery. | 2 months after start of PT |
| Functional Performance as Assessed by Single leg Hop Testing | Initiation of PT is 1 month after surgery. | 5 months after start of PT |
| Change in Activity as Assessed by Patient-Reported Score on the Marx Scale | Initiation of PT is 1 month after surgery. | at start of PT, 1 month after start of PT |
| Change in Activity as Assessed by Patient-Reported Score on the Marx Scale | Initiation of PT is 1 month after surgery. | at start of PT, 2 months after start of PT |
| Change in Activity as Assessed by Patient-Reported Score on the Marx Scale | Initiation of PT is 1 month after surgery. | at start of PT, 5 months after start of PT |
| Change in Activity as Assessed by Patient-Reported Score on the Tegner Activity Scale | Initiation of PT is 1 month after surgery. | at start of PT, 1 month after start of PT |
| Change in Activity as Assessed by Patient-Reported Score on the Tegner Activity Scale | Initiation of PT is 1 month after surgery. | at start of PT, 2 months after start of PT |
| Change in Activity as Assessed by Patient-Reported Score on the Tegner Activity Scale | Initiation of PT is 1 month after surgery. | at start of PT, 5 months after start of PT |
| Change in Knee Function as Assessed by Patient-Reported Score on the 2000 IKDC Subjective Knee Evaluation Form | Initiation of PT is 1 month after surgery. | at start of PT, 1 month after start of PT |
| Change in Knee Function as Assessed by Patient-Reported Score on the 2000 IKDC Subjective Knee Evaluation Form | Initiation of PT is 1 month after surgery. | at start of PT, 2 months after start of PT |
| Change in Knee Function as Assessed by Patient-Reported Score on the 2000 IKDC Subjective Knee Evaluation Form | Initiation of PT is 1 month after surgery. | at start of PT, 5 months after start of PT |
| Change in Kinesiophobia as Assessed by Patient-Reported Score on the Tampa Scale for Kinesiophobia | Initiation of PT is 1 month after surgery. | at start of PT, 1 month after start of PT |
| Kinesiophobia as Assessed by Patient-Reported Score on the Tampa Scale for Kinesiophobia | Initiation of PT is 1 month after surgery. | at start of PT, 2 months after start of PT |
| Change in Kinesiophobia as Assessed by Patient-Reported Score on the Tampa Scale for Kinesiophobia | Initiation of PT is 1 month after surgery. | at start of PT, 5 months after start of PT |
| Change in Physiological Impact of Returning to Sport After ACL Reconstruction Surgery as Assessed by Patient-Reported Score on the Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI) Scale | Initiation of PT is 1 month after surgery. | at start of PT, 1 month after start of PT |
| Change in Physiological Impact of Returning to Sport After ACL Reconstruction Surgery as Assessed by Patient-Reported Score on the Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI) Scale | Initiation of PT is 1 month after surgery. | at start of PT, 2 months after start of PT |
| Change in Physiological Impact of Returning to Sport After ACL Reconstruction Surgery as Assessed by Patient-Reported Score on the Anterior Cruciate Ligament-Return to Sport after Injury (ACL-RSI) Scale | Initiation of PT is 1 month after surgery. | at start of PT, 5 months after start of PT |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |