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The Rehabilitation Enhanced by Partial Arterial Inflow Restriction (REPAIR) Study will be conducted in a patient population of individuals recovering from a traumatic diaphyseal fracture of the femur. Although the intervention can be used for any patient with muscle weakness following trauma, the persistent thigh weakness that follows a femur fracture provides a perfect model for evaluating the effectiveness of the REPAIR protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care Physical Therapy | No Intervention | This group will receive the standard of care physical therapy program for 6 weeks. | |
| Blood Flow Restriction Plus Standard of Care Physical Therapy | Experimental | This group will receive the same standard of care physical therapy program for 6 weeks plus blood flow restriction. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood Flow Restriction | Other | Brief and intermittent blood flow restriction via a Delfi PTSII Tourniquet System will be used during physical therapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hip and Knee Strength measured using a stabilized hand held dynamometer | Five muscle actions were tested using a handheld dynamometer with the patient in the seated (knee extension, hip flexion), supine (hip abduction), and prone (knee flexion, hip extension) position. | up to 6 months |
| Muscle Volume assessed using mid-thigh girth circumference measurement | Two measures of thigh circumference were taken using a flexible measuring tape to estimate muscle volume; one measure was taken at 6 centimeters and one measure taken at 16 centimeters from the superior pole of the patella. | up to 6 months |
| Hip and Knee Range of Motion | Four assessments of active joint range of motion (hip and knee flexion and extension) were conducted using a goniometer | up to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa Reider, PhD | Major Extremity Trauma Research Consortium Coordinating Center | Study Director |
| Daniel J Stinner, MD | San Antonio Military Medical Center | Principal Investigator |
| Ellen J MacKenzie, PhD | Major Extremity Trauma Research Consortium Coordinating Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Methodist Hospital | Indianapolis | Indiana | 46202 | United States | ||
| University of Maryland Medical Center |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 29, 2026 | |
| Reset | Jun 24, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 29, 2026 | Jun 24, 2026 |
| ID | Term |
|---|---|
| D018908 | Muscle Weakness |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
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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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| Delfi PTSII Tourniquet System | Device |
|
| Baltimore |
| Maryland |
| 21201 |
| United States |
| Walter Reed National Military Medical Center | Bethesda | Maryland | 20889 | United States |
| Barnes Jewish Hospital | St Louis | Missouri | 63110 | United States |
| Carolinas Medical Center | Charlotte | North Carolina | 28204 | United States |
| MetroHealth | Cleveland | Ohio | 44109 | United States |
| University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
| San Antonio Military Medical Center | San Antonio | Texas | 78219 | United States |
| D009422 | Nervous System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |