Blood flow restriction therapy for Dislocations

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Keller Army Community Hospital - ARVIN, West Point, NY
Dislocations+5 More
Blood flow restriction therapy - Other
Eligibility
< 65
All Sexes
What conditions do you have?
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Study Summary

Describe the purpose and objective(s) of the study, specific aims, and/or research questions/hypotheses: The purpose of this Randomized Controlled Trial is to evaluate the effectiveness of Blood Flow Restriction (BFR) training with standard care of physical therapy versus the standard care of Physical Therapy alone and its effect on shoulder function and patient outcomes in military cadets recovering from shoulder stabilization surgery. We hypothesize after 6 weeks of BFR training will contribute to 13 (76%) or more participants will achieve scores within one standard deviation of normative values for isometric strength and functional tests at six months following shoulder stabilization surgery. Furthermore, we hypothesize that 14 (82%) or more participants will report improved patientreported outcomes as determined by the minimal clinical difference (MCD) at 12 weeks and six months post-operatively. Objective 1: To evaluate the effectiveness of blood flow restriction (BFR) training on shoulder isometric strength, as measured by a digital handheld dynamotor following shoulder stabilization surgery in military cadets. Objective 2: To evaluate the effectiveness of blood flow restriction (BFR) training on shoulder range of motion, as measured by a digital inclinometer, following shoulder stabilization surgery in military cadets. Objective 3: To evaluate the effectiveness of blood flow restriction (BFR) training on shoulder function as measured by the Closed Kinetic Chain Upper Extremity Stability Test (CKCUEST), Seated Shot-Put Test (SSPT), and Upper Quarter Y-Balance Test (UQYBT), following shoulder stabilization surgery in military cadets. Objective 4: To evaluate the effectiveness of BFR training on shoulder pain, measured by a numerical pain rating scale, following shoulder stabilization surgery in military cadets. Objective 5: To evaluate the effectiveness of a BFR training on patient-reported outcomes, measured by Single Assessment Numeric Evaluation (SANE), Shoulder Pain and Disability Index (SPADI), and the Quick Disabilities of Arm, Shoulder and Hand (DASH) following shoulder stabilization surgery in military cadets. Aim 1:To identify whether BFR with Physical Therapy is more effective at increasing shoulder strength than therapy alone following shoulder stabilization surgery. We hypothesize that the BFR with Physical Therapy group will be more effective at increasing shoulder strength than the Physical Therapy group without BFR following shoulder stabilization surgery. Aim 2:To identify whether BFR with Physical Therapy is more effective at increasing shoulder function than therapy alone following shoulder stabilization surgery. We hypothesize that the BFR with Physical Therapy group will be more effective at increasing shoulder function than the Physical Therapy group without BFR following shoulder stabilization surgery.

Eligible Conditions

  • Dislocations
  • Shoulder
  • Surgery

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

4 Primary · 5 Secondary · Reporting Duration: 6 months

6 months
Numerical Pain Rating Scale (NPRS)
Quick Disabilities of Arm, Shoulder, Hand (QDASH)
ROM
Shoulder Pain and Disability Index (SPADI)
Single Assessment Numeric Evaluation (SANE)
shoulder Isometric strength
shoulder function- (CKCUEST)
shoulder function- (UQYBT)
shoulder function-(SSPT)

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

standard therapy group
1 of 2
BFR group with standard therapy
1 of 2
Active Control
Experimental Treatment

40 Total Participants · 2 Treatment Groups

Primary Treatment: Blood flow restriction therapy · No Placebo Group · N/A

BFR group with standard therapyExperimental Group · 2 Interventions: Blood flow restriction therapy, Standard Physical Thearapy · Intervention Types: Other, Other
standard therapy group
Other
ActiveComparator Group · 1 Intervention: Blood flow restriction therapy · Intervention Types: Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months
Closest Location: Keller Army Community Hospital - ARVIN · West Point, NY
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N/AFirst Recorded Clinical Trial
0 TrialsResearching Dislocations
0 CompletedClinical Trials

Who is running the clinical trial?

Keller Army Community HospitalLead Sponsor
14 Previous Clinical Trials
1,990 Total Patients Enrolled

Eligibility Criteria

Age < 65 · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a lung cancer diagnosis in the age range of 17 to 30 years.
You are a USMA cadet who underwent primary or revision shoulder surgery procedures.
You are near 6 weeks post-operative and will be cleared to begin strengthening exercises at that time.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.