Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT05506072 |
Other study ID # |
22KACH005 |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
June 23, 2022 |
Est. completion date |
June 23, 2023 |
Study information
Verified date |
August 2022 |
Source |
Keller Army Community Hospital |
Contact |
Max K Dummar, DPT |
Phone |
845-938-3067 |
Email |
max.k.dummar.mil[@]mail.mil |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
Description:
During study:
Participants will be recruited from the Keller Army Community Hospital (KACH) the KACH
Orthopedic Clinic and the Arvin Cadet Physical Therapy Clinic. Participants will be screened
for possible benefits of participation and related inclusion
/exclusion criteria as is done within traditional means by the referring provider.
Participant recruitment and briefing by the lead primary investigator (PI) or associate
investigator (AI) will be conducted.
Participants wishing to participate in the study will undergo informed consent process with
PI or AI. Participants agreeing to participate will complete consent by signing an informed
consent form and HIPAA authorization form. All data will be recorded and stored by the
subject identification number. Participants will be randomized into their assigned group of
either receiving standard therapy with Blood Flow Restriction (BFR) or standard therapy alone
by a blinded therapist within the study using a computer generated randomization formula
Participants will then visit the clinic for study testing at six weeks, 12 weeks, and six
months after their surgery. During each of these visits, they will be asked to complete a
survey, and then their shoulder strength and flexibility will be measured. Each study visit
will last approximately 30 minutes. Participants will also attend 12-18 shoulder
rehabilitation sessions in the clinic over six weeks from the six week to 12 week mark (about
two to three sessions per week). Each rehabilitation session will last approximately 30
minutes and consist of Blood Flow Restriction Training and/or standard rehabilitation
exercises. Between the 12-week follow-up and 6-month follow-up, participants will receive
standard post-surgical rehabilitation for their specific shoulder surgery without Blood Flow
Restriction training. Baseline Testing All participants will undergo baseline testing at 6
weeks in the following order: 1.
Demographic data 2. self-report outcome measures; 3. Range of motion (ROM) testing; 4.
isometric strength testing. Initial patient reported outcome measures will be recorded on the
Numerical Pain Rating Scale (NPRS), the Single Assessment Numeric Evaluation (SANE), the
Shoulder Pain and Disability Index (SPADI), and the Quick Disabilities of Arm, Shoulder, Hand
(DASH).
Initial shoulder flexion, external rotation (ER), and internal rotation (IR) Range of Motion
(ROM) measurements will be conducted using the digital inclinometer Initial shoulder
isometric abduction, ER, and IR strength will be assessed using a handheld dynamometer.
Intervention Participants will either receive the current standard of care in post-operative
shoulder stabilization rehabilitation without BFR training during each treatment session or
current standard of care in post-operative shoulder stabilization rehabilitation plus BFR
training.
BFR will be done via Delfi Portable Tourniquet System (BFR (Delfi Medical Innovations Inc.,
Vancouver, Canada) All participants will perform their rehabilitation a minimum of two times
per week in the rehabilitation clinic. Patient contact time with their medical providers will
be the same in both groups. The BFR treatment with the BFR group will be applied during each
treatment session for 6 weeks (weeks 6-12). Pain will be assessed at the beginning and end of
each treatment session using the Numerical Pain Rating Scale, in accordance with standard
clinical practice. Exercise intensity will be determined each session using the OMNI res
scale and participants will use that load for their daily exercises. The BFR group will
exercise at an intensity of 2-3 on the OMNI res scale on the involved side and then exercise
at a 6-8 on the uninvolved side. The non-BFR group will exercise at a 6-8 on the involved and
uninvolved side. These loads will be annotated and used be referred to when completing
strengthening exercises. Participants will then perform a 30-minute session of
rehabilitation. The BFR group will apply the BFR tourniquet and it will be inflated to 50%
Limb Occlusion Pressure (LOP) throughout the duration of the treatment. The upper body
aerobic exercise will be performed on an upper body cycle (UBC). Intensity will be determined
by the perceived exertion of OMNI Res at a resistance the participant considers easy(2-3).
The strengthening exercises will consist of three unilateral standing exercises to be
performed on both upper extremities. The exercises to be performed are ER with the shoulder
adducted to the thorax, scapular retraction with a combined low row, and flexion in scapular
plane. Each exercise will be performed while standing using Keiser Functional Trainer (Keiser
Corp model 003025.15, Fresno, CA). The resistance for the strengthening exercises will be
selected as described above using the Omni res scale. All participants will perform 75
repetitions in total per exercise broken in to 4 sets (30,15,15,15). A 30 second rest period
will be issued between exercises. Participants will be permitted to increase or decrease the
resistance as needed to stay within the specified perceived exertion range but will be
annotated for any deviation from pre-load assessment. The treatment session will end when a
participant completes all sets and repetitions for each exercise. However, if a participant
is unable to complete all exercises in 30 minutes, the BFR cuff will be deflated and removed.
Then, the participant will finish the exercises without BFR. Patients will also perform a
home exercise program(HEP) that reinforces the in-clinic treatment. Compliance with the home
exercise program will be documented by a patient log to be completed daily and turned into
the project manager weekly. All groups will perform their HEP strength exercises at same
perceived load intensity of a 6-8 on the OMNI res scale. Assessments (6 weeks); Follow up
(12-week, and 6 months post-surgery)
All participants will undergo baseline and follow-up testing in the following order: 1. self
report outcome measures; 2. Range of motion testing; 3. isometric strength testing; 4.
Functional testing at 6-month follow-up only Follow-up patient reported outcome measures will
be recorded on the Numerical Pain Rating Scale (NPRS), the Single Assessment Numeric
Evaluation (SANE), the Shoulder Pain and Disability Index (SPADI), and the Quick Disabilities
of Arm, Shoulder, Hand (DASH). Shoulder flexion, external rotation (ER), and internal
rotation (IR) Range of Motion (ROM) measurements will be conducted using the digital
inclinometer Shoulder isometric abduction, ER, and IR strength will be assessed using a
hand-held dynamometer. Functional tests will be conducted in the same order: Closed Kinetic
Chain Upper Extremity Stability Test (CKQUEST), Upper Quarter Y Balance Test (UQYBT), Seated
Shotput Test (SSPT) Study participation completed after the 6-month follow-up