36
Participants
Start Date
May 13, 2025
Primary Completion Date
March 31, 2027
Study Completion Date
December 31, 2028
Active BFRT
The BFR device is applied unilaterally on participants involved upper extremity. The BFR device maintains 50% of participants limb occlusion pressure for the duration of each strengthening exercise.
Sham BFRT
The BFR device is applied unilaterally on participants involved upper extremity. The BFR device maintains a pressure of 20mmHg for the duration of each strengthening exercise.
Strengthening Exercises with BFRT
Participants perform 4 strengthening exercises while using the BFR device: seated scapular plane elevation, prone horizontal abduction, side-lying external rotation, and prone scapular plane elevation. Each exercise is performed unilaterally. Participants perform 1 set of 30 repetitions followed by 3 sets of 15 repetitions (4 total sets, 75 total repetitions). Participants are given 30 seconds rest between sets and 2 minutes of rest between strengthening exercises. Selected resistance for each strengthening exercise is equal to 20% of the participant's maximal force production as measured by handheld dynamometry. Resistance is adjusted weekly.
Skilled Physical Therapy Care
Participants perform non-strengthening interventions as part of skilled physical therapy care. Non-strengthening interventions include an upper arm ergometer for warm-up, active assisted range of motion of the shoulder, shoulder stretching, shoulder joint mobilizations, and cryotherapy. Non-strengthening interventions are prescribed at the discretion of the treating physical therapist. Participants are enrolled in physical therapy for a minimum of 4 weeks. After 4 weeks, the treating physical therapist can discharge a participant based on their progress in meeting their rehabilitation goals. Participants discharged from skilled physical therapy care will continue to complete strengthening exercises with BFRT until the end of the trial period (8 weeks).
RECRUITING
University of Florida, Gainesville
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
NIH
University of Florida
OTHER