Rehabilitation Enhanced by Partial Arterial Inflow Restrictions

NCT02746458 | Active Not Recruiting DMC

• 1 other identifier: W81XWH-15-2-0067
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Closed Femur Fracture

Keywords

Blood Flow Restriction; Muscle Weakness; Physical therapy techniques; closed femoral fracture injuries

Outcome Measures

Primary Outcomes (2)

• Knee Strength measured using a stabilized hand held dynamometer

  Knee strength will be measured using a stabilized hand held dynamometer in both the injured and uninjured legs.

  up to 6 months

• Muscle Volume assessed using mid-thigh girth circumference measurement

  Muscle volume will be assessed using mid-thigh girth circumference measurements.

  up to 6 months

Secondary Outcomes (17)

• Strength

  up to 6 months

• Speed

  up to 6 months

• Speed

  up to 6 months

• Posture Stability

  Change in Functional Performance Measures at 3 months and 6 months

• Agility

  up to 6 months

Study Arms (2)

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.

Other: Blood Flow Restriction; Device: Delfi PTSII Tourniquet System

Interventions

Blood Flow Restriction OTHER

Brief and intermittent blood flow restriction via a Delfi PTSII Tourniquet System will be used during physical therapy.

Blood Flow Restriction Plus Standard of Care Physical Therapy

Delfi PTSII Tourniquet System DEVICE

Blood Flow Restriction Plus Standard of Care Physical Therapy

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adults ages 18-55 inclusive
• Admitted to one of the participating clinical centers for operative treatment of a closed diaphyseal femur fracture with one of the following OTA codes: 32A, 32B or 32C (treated with an IM Nail).

You may not qualify if:

• Open diaphyseal femur fracture (except low velocity gunshot wounds) or severe crushing injuries to study limb.
• Additional fracture, dislocations or soft tissue injuries to the study limb that would compromise the ability to weight bear as tolerated and initiate PT within 28 days of definitive fixation.
• Any fractures, dislocations or soft tissue injuries to the contralateral limb or pelvis that would compromise the ability to weight bear as tolerated and initiate PT within 28 days of definitive fixation.
• Any treatment of the study injury in either group that would preclude application of the tourniquet cuff (e.g. vascular reconstruction, wound, flap, or skin graft).
• Injuries to other body systems (or other medical conditions) that would preclude the ability to weight bear as tolerated and initiate PT within 28 days of definitive fixation (e.g. spinal cord deficit; severe traumatic brain injury).
• Use of blood flow restriction (BFR) at any time between treatment and the start of physical therapy for the study.
• Non-ambulatory pre-injury.
• Morbidly obese (BMI \> 40).
• History of Peripheral Artery Disease and/or Peripheral Vascular Disease (PAD/PVD).
• Current or history of venous thromboembolism.
• Impaired circulation or peripheral vascular compromise.
• Previous revascularization at the study injury site.
• Extremities with dialysis access.
• Current diagnosis of acidosis.
• Diagnosis of sickle cell anemia.

Sponsors & Collaborators

• Major Extremity Trauma Research Consortium: lead

Study Sites (8)

Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28204, United States

Location

MetroHealth

Cleveland, Ohio, 44109, United States

Location

University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

San Antonio Military Medical Center

San Antonio, Texas, 78219, United States

Location

MeSH Terms

Conditions

Muscle Weakness

Interventions

Blood Flow Restriction Therapy

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2016
• First Posted: April 21, 2016
• Study Start: April 1, 2016
• Primary Completion: September 1, 2023
• Study Completion: August 1, 2024
• Last Updated: May 1, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)