Efficacy of a Digital Kinematic Biofeedback System for Rehabilitation After Arthroscopic Rotator Cuff Repair Versus Conventional In-person Rehabilitation: a Randomized Controlled Study
Phase: NA
Conditions: Rotator Cuff Tear
Sponsor: Sword Health, SA

 
 
 
 
 
 
 
Study Protocol 
 
 
 
STUDY ID: SH-RCT-ARCR-01 
 
 
Home-based Rehabilitation with a novel digital biofeedback system 
versus conventional home-based rehabilitation after Arthroscopic 
Rotator Cuff Repair: a randomized controlled trial 
 
Document Version: 2.0 
 
Date: 06/14/2018 
 
 
 
Sponsor: SWORD Health, SA 
 
 
 

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Revision History 
 
Version 
Date 
Description 
Author 
1.0 
02/03/2017 
Original 
J.G & F.C. 
2.0 
06/14/2018 
Content revision 
S.L. 
 
 
Principal Investigator 
Fernando Emanuel Dias Correia 
Largo Prof. Abel Salazar 
4099-001 Porto 
Contact: 966557789 
E-mail: fanacorreia@gmail.com 
 
Co-Investigators 
 
António Rosmaninho Seabra 
Rua Sarmento Beires 153 
4250-449 Porto 
Email: rosmaninho.seabra@hospitaldaprelada.pt 
 
Sara Raquel Luís 
Rua de Sá da Bandeira, nro 651 1º direito 
4000-437 Porto 
Contact: 914710560 
E-mail: sararluis@gmail.com 
 
Investigation Centers  
Hospital da Prelada - Dr. Domingos Braga da Cruz 
Rua Sarmento Beires 153 
4250-449 Porto 
 

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1. Introduction 
Shoulder pain is highly prevalent, being the third main complaint in primary care 
settings.1–3 In fact, in developed countries, 1% of adults are expected to consult 
primary care at some point in life due to shoulder pain.1 
 
Problems in the rotator cuff tendons are very common,4–10 mainly after the 4th decade 
of life,1,11 and more than 80% of the population over 70 years,12 and it is estimated 
that 65 to 70% of all shoulder pain complaints involve these structures.1,4 
 
Rotator cuff tendinopathy is preceded with tendon disorganization and thickening that 
leads to a reduction of its physical properties, and in more severe cases leads to 
tendon rupture.10 Rotator cuff tears disrupt shoulder kinematics,1,4,13 and usually lead 
to loss of function, dyskinesia, pain and stiffness,10,14,15 with a consequent negative 
effect on the individual’s function and therefore quality of life.13,16  
 
Rotator cuff tears are the most common cause of pain and loss of function in overhead 
activities,17,18 representing a huge burden for healthcare systems, insurance companies 
and employers alike.1,19 Symptoms may vary according to size, location or type of 
tear, with some people maintaining asymptomatic while others may have significant 
levels of pain, as well as loss of function and strength.1,7 In fact, from 5 to 40% of 
people with asymptomatic shoulders may have full-thickness rotator cuff tears.1,2 
 
Since conservative treatment is not always effective,1,20 rotator cuff repairs are 
commonly used surgical procedures1,4,25,26,10,15,17,20–24 and a procedure that is 
becoming more frequent in advanced ages.22,27  

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Rehabilitation plays an essential role in the recovery of rotator cuff repair,8–
10,13,15,20,28–31 and should be customized to the patients characteristics and 
needs.15,18,20,32  Different aspects must be taken into consideration for functional 
recovery, such as age, activity levels, extent and location of the tear, duration of 
symptoms, 
prior 
muscle 
atrophy 
or 
fatty 
infiltration 
and 
concomitant 
pathologies.10,17,20,23,24,31,33  
 
The primary goal of the rehabilitation is to relieve pain, restore function, range of 
motion, strength,4,20,29,31,34–36 balancing the need of protecting the repair and the need 
of 
mobilization 
to 
avoid 
stiffness 
and 
restore 
normal 
function 
and 
kinematics.15,20,30,31,37,38  This balance, however, is very delicate, as re-tears or failed 
healing are very common after surgery22,25,27,39, and therefore therapies must focus on 
improving function without compromising the healing process.15,27,31 
 
Assure an early passive range of motion is recommended by many authors to prevent 
stiffness, one of the most frequent complications after rotator cuff repairs15,37,38,40–42 as 
well as joint adhesions and further tendon degradation. Conversely, longer 
immobilization periods can promote tendon healing and reduce the rates of re-
tear.32,37,38,43 There is no consensus on this matter, with an immobilization period of 6 
weeks being the most common period advised.20,28 However, several studies found no 
differences between them in function, pain, ROM or re-tears ratio, concluding that 
early mobilization may be beneficial.22,23,28,30,34,37,38,40,41 Furthermore, some studies 
demonstrate that early initiation of rehabilitation with active exercise does not appear 
to affect patient-reported pain and disability outcomes in a short (≤ 3 months), mid (6 

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months) or long-term period (≥ 12 months).8,9,36 Still, even within the early 
mobilization group, there is no consensus on how early should the mobilization begin 
-  since day one to 2 days after, 1 week after, 5 weeks after.4,28,41 
 
Apart from the discussion between early or late passive mobilization, there is also no 
consensus on which rehabilitation programs are better.8–10,15,17,26,38 Several studies and 
systematic reviews have been published on the subject, focusing mainly on the times 
of progression.4,8,40–42,44,45,23,28–30,32,34,37,38 These studies all define a four-stage process 
consisting of: a) immobilization, b) passive range of motion; c) active range of motion 
and d) strengthening, with variable times of progression.9,15,20,28,33  The total duration 
of the rehabilitation process is also variable, with some studies stating that it might 
take up to 6-12 months to regain full strength.4,33,35  
 
Regarding rehabilitation setting, some studies suggest that home-based therapy, based 
on exercise, could be as effective as clinic-based interventions.21,26,46,47 This is in line 
with the recent trends in healthcare delivery, away from inpatient care and towards 
home-based care with the intent of improving cost-effectiveness. 
 
Given the high incidence and prevalence of shoulder rotator tears, and the associated 
morbidity, which represents a huge economic burden3,16,48 it is essential to ensure the 
access to cost-effective rehabilitation.47 In this regard, digital health solutions that 
empower patients, maximize engagement and allow home-based rehabilitation 
without the need for constant therapist supervision, could improve effectiveness and 
lower the cost of rehabilitation.   
 

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SWORD Health has developed a novel digital biofeedback system for home-based 
physical rehabilitation (SWORD Phoenix®). Using inertial motion trackers, this 
system digitizes patient motion and provides real-time feedback on performance 
through a mobile app. It also includes a web-based platform that allows the clinical 
team to prescribe, monitor and adapt the rehabilitation process remotely. This way, 
the system allows patients to perform independent rehabilitation sessions at home 
without the need for constant therapist supervision, ensuring remote monitoring 
throughout the rehabilitation program. 
 
2. Study Objective 
The objective of the present study is to evaluate the clinical outcomes of a home-
based rehabilitation program using this system against conventional home-based 
rehabilitation after arthroscopic rotator cuff repair. We hypothesize that the clinical 
outcomes of such a program will be at least similar to those of traditional 
rehabilitation. 
 
3. Study Design 
This study is a single-center, prospective, non-blind, parallel-group, randomized 
controlled trial with an active comparator. 
 
4. System technical specifications 
The version of SWORD Phoenix used in this study is composed of the follow 
components: 
a) Inertial motion trackers: each one is composed of a three-axis gyroscope, 
three-axis accelerometer and a three-axis magnetometer, allowing 3D 

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movement analysis and quantification. The trackers communicate via 
Bluetooth LE with a tablet computer. 
b) Mobile App: a mobile app that processes the information generated by the 
motion trackers and provides real-time biofeedback regarding movement 
quality and patient performance.  
c) Web-based Portal: a web-based platform that allows the clinical team to 
prescribe motor tasks and monitor results. 
 
 
Motion Trackers 
The motion trackers are placed on body segments using Velcro® straps. Each motion 
tracker is placed in a specific position. To assist in the correct placement of the 
motion trackers, both the trackers and the matching straps are color-coded. In this 
study, the following setup will be used: 
 
- 
Red tracker: over the sternal manubrium 
 
- 
Green tracker: on the medium third of the external surface of the upper arm, 
pointing to the elbow 
 
- 
Blue tracker: on the dorsal surface of the distal third of the forearm, pointing to 
the hand 
 
Mobile App 
The mobile app guides the patient in each exercise session. Before each exercise, the 

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patient is presented with a real-life video and audio explanation of that exercise. The 
execution interface is subsequently shown. This screen features: a) a posture dummy 
indicating correct/incorrect posture; b) a progress bar; c) a timer indicating rest time 
between repetitions and prompting start when rest time is over; d) a repetition 
counter; e) a star counter and f) a timer displaying time left to complete the exercise. 
Only correctly performed repetitions count towards the repetition counter. A correct 
repetition is defined as a movement starting at the baseline and reaching or surpassing 
the specified target, without violating movement or posture constraints. In case the 
patient violates a movement constraint, a message is prompted showing which 
movement error was performed, so that the patient can correct the movement in the 
following attempts. 
For each correct repetition, the patient earns from 1 to 3 stars, depending on how 
much he was able to surpass the target, as long as he has not violated any movement 
or posture constraints.  
 
Web Portal 
The portal is a web-based platform that allows the clinical team to create new patient 
profiles and create exercise sessions for each patient. When a patient performs a 
session, the results are uploaded to the platform and available for review. Based on 
this information, the clinical team can edit the parameters of each session and exercise 
according to patient performance and progress. 
 
5. Study Outcomes 
The assessment of the effectiveness of treatments in shoulder conditions is 
complex49,50 and should include not only the traditional clinical outcomes, such as 

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joint measures, but also the assessment of functional deficits, through patient reported 
outcome measures.49–51 Lately, there has been a shift towards the latter, which are 
currently the primary outcomes of most research studies.49 
The Constant Shoulder Score is one of the most used outcome assessment tools 
worldwide,49,50,52,53 maybe due to the fact that it’s psychometric properties have been 
widely studied,50 and that it includes essential measures - physical assessment of 
strength and motion - as well as patient-reported function.49,52,53 Additionally, it is 
considered, in some studies, as a gold standard or “reference scale”,51 and its 
extensive use allows for comparisons between study samples and results.49 
The DASH questionnaire also provides a very accurate assessment51 and has been 
recommended to be the first line of assessment in shoulder disorders, due to its high 
responsiveness and well-established benchmarks.52 The QuickDASH, its short 
version, with 11 items, is also validated, and its psychometric properties are very high 
and similar to the original long version.52,54 The use of QuickDASH was analysed in 
patients with a rotator cuff repair and was recommended to assess patients who 
underwent a surgery process,54 therefore applicable in the present context. 
Although the use of patient-reported outcome measures is highly recommended, 
conventional measures such as range of motion are still clinically relevant and critical 
part of shoulder assessment.17,52 Shoulder flexion, abduction, internal and external 
rotations are the mainly cited movements, although with high variability in the 
positions of measure.52 
Based on this evidence, the following outcomes will be measured: 
a) functional assessment – Constant Score 
b) patient-reported outcomes  - QuickDASH 

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c) range of motion of the shoulder (in degrees) 
The outcome measures will be assessed pre-operatively, and then at 6, 12, 16 and 20 
weeks after the surgery. In patients where a decision is made to extend the program to 
24 weeks, another assessment will be made at this point. 
 
5.1 Primary outcome 
The primary outcome will be the change in patient functional assessment compared to 
the baseline, measured through the Constant Score.  
 
5.2 Secondary outcomes 
The secondary outcomes will be: 
- 
The change in patient reported function in comparison to the baseline, 
measured by the QuickDASH score 
- 
The change in shoulder range of motion in comparison to the baseline, 
measured by the shoulder flexion degree in a sitting position (in degrees)   
 
6. Sample size estimate 
Sample size estimation was performed taking into consideration the primary outcome 
measure – The Constant Score - and a non-inferiority scenario.  
In the absence of similar studies, the calculations were made taking into account the 
study by Arndt et al. (2012)40. This was a large study (n=100 patients) which 
compared two different rehabilitation protocols after ARCR and which used the same 
primary outcome as our study. In this study, the standard deviation of the Constant 

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Score at baseline was 12.0. A Minimal Clinically Important Difference (MCID) of 
10.4 was considered, based on the study by Constant et al. (2008).55  
Considering a power of 90%, a two-sided 0.05 significance level and a 10% dropout 
rate, 68 patients would be necessary to detect a 10.4 points difference between the 
two groups. 
 
7. Location of Recruitment 
Patients will be recruited at Hospital da Prelada - Dr. Domingos Braga da Cruz. 
 
8. Inclusion criteria 
a) Patients over 18 and under 70 years old 
b) Shoulder pain and functional limitation with clinical examination compatible 
with reparable rotator cuff tear 
c) Imaging (MRI or ultrasound) evidence of rotator cuff tear (supra and/or 
infraspinatus tendon tear inferior to 5cm) 
d) Indication for a rotator cuff repair according to the patient´s orthopedic 
surgeon 
e) Ability to understand simple and complex motor commands  
f) Availability of a carer to assist the patient after surgery 
 
9. Exclusion criteria 
 
Preoperative 
a) Patients with indication for revision cuff repair 
b) Complex cuff tears (involving subscapularis tendon or more than one tendon 
besides supra and infraspinatus, or massive dimension tears) 

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c) Glenohumeral arthritis 
d) Irreparable tendon defect 
e) Patients with concomitant neurological disorders (ex. Stroke, Parkinson´s 
disease, multiple sclerosis) 
f) Aphasia, dementia or psychiatric comorbidity interfering with the 
communication or compliance to the rehabilitation process 
g) Respiratory, cardiac, metabolic conditions or others incompatible with at least 
30 minutes of light to moderate physical activity 
 
Postoperative 
h) Irreparable tendon lesion 
i) Major medical complications occurring after surgery that prevent the 
discharge of the patient within 5 days after surgery 
j) Other medical and/or surgical complications that prevent the patient from 
complying with a rehabilitation program 
k) Blind and/or illiterate patients 
 
10. Methods for identifying and recruiting patients  
All patients admitted for rotator cuff repair during the study period will be screened 
for inclusion and exclusion criteria. 
When a potential candidate is identified, the local investigator will approach the 
candidate and explain the study in detail. The prospective candidate will be given the 
patient information document and sufficient time to consider whether he wishes to 
participate in the study.  
Subsequently, the prospective candidate will be given opportunity to clarify any 

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doubts, after which the informed consent form will be signed and dated in duplicate 
by the patient and the investigator. Only then will the randomization and baseline 
assessments be performed. 
 
11. Patient allocation to study groups 
For logistic reasons, the study will be restricted to patients living in a 20km radius 
around the investigation center. Patient allocation to the two groups will be performed 
in a random way, in a 1:1 ratio in blocks of six. This will be done using an online 
randomizer (https://www.randomizer.org).   
The allocation of patients to each group will be performed centrally by one 
investigator - F.D.C. - and communicated to the responsible for data acquisition only 
after patient enrollment. This investigator will not be involved in data collection or in 
outcomes assessment. 
 
12. Blinding 
The nature of the study does not allow blinding of the patients regarding study groups. 
However, participants will be blinded to the primary and secondary outcomes being 
measured.  All patient assessments will be performed by an investigator blinded for 
randomization groups. Statistical analysis will be performed blinded for 
randomization group.  
 
13. Patient assessment 
Patients will be assessed pre-operatively, and then at 6, 12, 16 and 20 weeks after the 
surgery. In patients where a decision is made to extend the program to 24 weeks, 

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another assessment will be made at this point. An assessment will also be made at 12 
months after surgery. 
 
13.1 Baseline assessment 
Participant characterization will consist of:  
a) Demographics (gender, date of birth);  
b) Educational level (years); 
c) Affected side 
d) Injured structures 
e) Size of tear 
f) Date of surgery 
g) Comorbidities 
a. Factors affecting tissue healing: Smoking, Diabetes, Steroid intake 
b. Other disorders: cardiac, respiratory, hypertension 
c. Time between diagnosis and surgery 
h) Body Mass Index 
i) Constant score 
j) QuickDASH 
k) Shoulder range of motion 
 
13.1.1 Constant Score 
The Constant Score is a functional assessment score specific to the shoulder 
region, that varies between 0 and 100 points, being 100 the best score possible. 
This total score is distributed in subjective assessments of pain and activities of 

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daily living (15 and 20 points, respectively) and objective measures of shoulder 
range of motion and strength (40 and 65 points, respectively).55 
The Constant Score is the most used instrument to assess the shoulder in Europe 
and its psychometric properties prove it to be a valid, reliable and responsive 
measure.56,57 Kukkonen et al. (2013)56 determined that the Minimum Clinical 
Important Difference - MCID of the Constant Score for patients with 
arthroscopically treated rotator cuff repairs was of 10.4 points. 
 
13.1.2. QuickDASH 
The shortened version of the Disabilities of the Arm, Shoulder and Hand 
(QuickDASH) is an 11-item self-administered outcome measure, specific to 
measure disability and symptoms in individuals with musculoskeletal disorders of 
the upper limb.58 Each item has a 5 option Likert scale, from “no difficulty” to 
“unable to do” (1 to 5), and the total raw score is obtained through the sum of the 
answers and then converted into a 0-100 scale with a negative orientation, in which 
no disability indicates a score of zero and maximum disability a score of 100, 
determining the functional activity level. It is an instrument widely used for 
clinical or research purposes and which has proven to be a valid, reliable and 
responsive measure.54,58,59 Franchioni et al. (2014)59 have determined the MCID 
for the QuickDash in patients with study pain as 15.19. 
 
13.1.3 Shoulder range of motion 
The shoulder range of motion will be measured in the sitting position. 
The system used in the study is a validated medical device for joint angle 
measurement. Therefore, shoulder range of motion will be measured automatically 

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by the system. 
In this study, active range of motion will be measured in the following movements: 
a) Elevation of the shoulder in the scapular plane, sitting: with the patient sitting, 
with the arm fully extended, have the patient actively raise the arm in the 
scapular plane as much as possible, with extended elbow. 
b) Sitting shoulder flexion: with the patient sitting, with the arm fully extended, 
have the patient actively raise the arm as much as possible, with extended 
elbow. 
c) Sitting Shoulder Abduction: with the patient sitting, with the arm as close as 
possible to the body, have the patient actively open the arm as much as possible, 
with extended elbow. 
d) Sitting Shoulder External Rotation: with the patient sitting with 90º bent elbow 
and hand pointing forward, have the patient actively rotate the arm outwards, as 
much as possible. 
 
In order to achieve this, the investigator will need to: 
1) Create a new patient in the Phoenix Portal 
2) Prescribe these four different exercises, described above 
3) Setup SWORD Phoenix  
4) Ask the patient to perform five repetitions of each movement to the best of his 
ability, while SWORD Phoenix records movement parameters 
5) After the session, login to the Portal, go to the session´s results and click on 
detailed results for each exercise. Record the value of best repetition for each 
exercise in the patient file. 
 

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13.2 Assessments at 6, 12, 16, 20 (and/or 24) weeks after surgery and assessment 
12 months after surgery 
These assessments will include: 
a) Constant score 
b) QuickDASH 
c) Shoulder range of motion (as described for the baseline assessment) 
 
14. Intervention 
Both study groups will receive early-onset home-based rehabilitation for 20 weeks, 
starting two weeks after surgery.28 This program can be extended for another 4 weeks 
if necessary. 
 
The experimental group will perform daily home-based rehabilitation sessions using 
SWORD Phoenix, under remote monitoring by a physiotherapist, as well as home 
one-to-one physiotherapy sessions, with decreasing periodicity depending on program 
stage. 
  
The conventional rehabilitation group will receive home-based rehabilitation provided 
by a physiotherapist, 3 times a week, for 1 hour. Patients will also be instructed to 
perform additional unsupervised sessions in at least two other days of the week. 
Compliance to these additional sessions is not mandatory, but patients will be asked 
to fill in a diary regarding these extra-sessions. 
 
The intervention arm, additionally to the one-to-one sessions, will perform daily 
home-based rehabilitation sessions using the system alone, under remote monitoring 

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by a physiotherapist. Patients will be instructed to perform exercise sessions at least 5 
times per week, but compliance to that frequency is not mandatory per protocol. The 
number of sessions, daily adherence and total training time will be registered 
automatically by the system and will be made available through the Web Portal, from 
where it can be transcribed to each patient file. When required, additional visits or 
telephone calls for technical assistance can be performed by the physical therapist. 
These will be registered as such in the patient file. 
 
In the absence of a gold standard, the rehabilitation protocols were designed taking 
into account: a) a recent systematic review on the subject;4 b) a review of the concepts 
and evidence-based guidelines on this subject by van der Meijden et al. (2012)15; c) 
an overview of systematic reviews comparing early and conservative rehabilitation28 
and d) the protocol of the Massachusetts General Hospital for rehabilitation after 
rotator cuff repair. 
 
The rehabilitation program will be based on the principles outlined in the following 
tables 1-4. In any case, these protocols can be tailored to the patient´s specific needs, 
according to the assessment of the orthopedic surgeon and the physical therapist. 
 
 
 
 
 
 
 

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Table 1. Immediate Post-op Phase  
Rotator cuff repair program: Immediate 
Post-op Phase (weeks 0 to 2) - Immobilization period 
Goals 
Precautions 
Control pain and swelling 
Protect the rotator cuff repair 
Protect wound healing 
Prevent shoulder stiffness 
 
Do not lift the operated arm 
 
Intervention 
Conventional PT group 
Experimental Group 
Use of a sling during the day and during the night until week 4 
Ice pack application to the operated shoulder for 15 minutes if necessary to reduce pain and 
swelling several times per day 
Promote the active movement of fingers, hand and elbow to increase circulation 
Gentle pendulum exercises for three to five minutes every one to two hours 
 
Table 2. Phase 1 of the rehabilitation program (weeks 2 to 4) 
Rotator cuff repair program: Phase 1 - Immobilization period 
Goals 
Precautions 
Control pain and swelling 
Protect the rotator cuff repair 
Protect wound healing 
Prevent shoulder stiffness 
 
Do not lift the operated arm 
 
Intervention 
Conventional PT group 
2 weeks 
2 face-to-face sessions per week 
Experimental Group 
2 weeks: 1 face-to-face session per week 
Daily sessions with SWORD Phoenix 
Ice pack application on the shoulder for 15 
minutes to reduce pain and swelling 
Active mobilization exercises of the scapula, 
elbow, forearm and hand 
Pendular exercises 
Drainage massage, when needed 
Intervention of the Control Group +  
SWORD Phoenix Exercises: 
- 
Scapula Elevation 
- 
Scapula Protraction 
- 
Scapula Retraction 
- 
Elbow Flexion 
- 
Forearm Supination 
- 
Forearm Pronation 
- 
Pendular Exercises 

Table 3. Phase 2 of the rehabilitation program (weeks 5 to 7/9) 
Rotator cuff repair program: Phase 2 - passive mobilization 
Goals 
Precautions 
Maintain integrity of the repair 
Avoid overstress healing tissue 
Gradually increase soft passive range of 
motion 
Diminish pain and inflammation 
Prevent muscular inhibition 
Begin early shoulder motion 
Reach 120º passive scapular mobility 
Reach 40º passive external rotation 
Reach 120º passive shoulder flexion 
No active elevation for the first six weeks 
No lifting of objects 
No excessive stretching or sudden 
movements 
No supporting of body weight by hands 
Avoid resisted exercises and exercises in 
coronal plane abduction 
No mobilization of the shoulder for 
flexion on the scapular plane (20º to 30º) 
between 60º and 110º if rotator tear suture 
Avoid shoulder external rotation until the 
8th week if shoulder instability 
Intervention 
Conventional PT group 
5 weeks 
3 face-to-face sessions/week 
Experimental Group 
5 weeks:2-2-2-2-1 face-to-face sessions* 
daily sessions with SWORD Phoenix 
 
Ice pack application on the shoulder for 15 
minutes to reduce pain and swelling 
Sub-maximal isometric strengthening: 
internal and external rotation at neutral 
Start soft passive ROM movements: 
- Limit lying internal rotation to 30° in the 
scapular plane (20° to 30°) 
- Lying external rotation to 60° in the 
scapular plane (20° to 30°) 
- Lying shoulder flexion in the scapular 
plane (20° to 30°) 
When passive ROM starts to improve, 
progress to soft active-assisted exercises 
(lying flexion, external and Internal 
rotation) 
Exercises: Ball squeezes, AROM for 
elbow, forearm and hand, scapular elevation 
and retraction 
 
Intervention of the Control Group  
+  
SWORD Phoenix Exercises: 
- 
Scapula Elevation 
- 
Scapula Protraction 
- 
Scapula Retraction 
- 
Elbow Flexion 
- 
Forearm Supination 
- 
Forearm Pronation 
Legend: * progressing to 1 session/week when possible 
Patients may progress to the next phase after completing all passive range of motions 
of the shoulder described with no pain associated. 

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Table 4. Phase 3 of the rehabilitation program (weeks  8-10 to 12-14) 
Rotator cuff repair program: Phase 3 - active movements 
Goals 
Precautions 
Maintain integrity of the repair and avoid 
overstress healing tissue 
Gradually increase to assisted and active 
range of motion 
Progressive scapular stability  
Progressive functional training  
Restore full shoulder motion 
Respect previous precautions 
Do soft strengthening exercises under 1,5kg 
Weight training precautions 
Avoid excessive force on the shoulder 
 
Intervention 
Conventional PT group 
5 weeks 
3 face-to-face sessions/week 
Experimental Group 
5 weeks: 1 face-to-face session/week 
daily sessions with SWORD Phoenix 
Gradually progress to full ROM all planes: 
increasing angles of abduction in external 
and internal rotation and lying horizontal 
adduction 
Active-assisted arm flexion, progressing to 
active shoulder flexion  
Dynamic exercises:   
- 
Side-lying and sitting external rotation;  
- 
Side-lying and standing scaption 
- 
Prone row, T, extension and scaption 
- 
External Rotation 
- 
Wall Slide 
- 
Internal Rotation behind back 
- 
Horizontal Abduction 
Stretching: 
- 
Prone extension 
- 
Lying external Rotation/with abduction 
- 
Lying/standing/sitting 
active-assisted 
Arm Elevation 
- 
Standing forward flexion (“full can”) 
exercise 
- 
Supine Cross-Chest Stretch 
- 
Wall slide Stretch 
Intervention of the Control Group  
+  
SWORD Phoenix: 
- 
Scapula Elevation 
- 
Scapula Protraction 
- 
Scapula Retraction 
- 
Elbow Flexion 
- 
Forearm Supination 
- 
Forearm Pronation 
- 
Shoulder Flexion 
- 
Shoulder External Rotation 
- 
Shoulder Internal Rotation 
- 
Shoulder Horizontal Abduction 
- 
Arm circles with 90º flexion 
- 
Push-up against a wall 
Patients may progress to the next phase after completing all active range of motions of the 
shoulder described with no pain associated. 
 
 

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Table 5. Phase 4 of the rehabilitation program (weeks 13-15 to 18-20) 
Rotator cuff repair program: Phase 4 – strengthening 
Goals 
Precautions 
Maintain integrity of the repair and avoid 
overstress healing tissue 
Progressive rotator cuff strengthening and 
scapular stability  
Progressive functional training  
Re-establish dynamic shoulder stability 
Re-establish scapulohumeral rhythm  
Restore full shoulder strength 
Gradually begin to return to normal activity 
Respect previous precautions 
Do soft strengthening exercises under 3,0kg 
Weight training precautions 
Avoid excessive force on the shoulder  
Intervention 
Conventional PT group 
6 weeks 
3 face-to-face sessions/week 
Experimental Group 
6 weeks:1-0-1-0-1-0 face-to-face sessions 
daily sessions with SWORD Phoenix 
Continue as above and progressively add: 
- 
Shoulder Abduction to full 
ROM 
Theraband exercises: 
- 
Standing 
external 
rotation 
(at 
0° 
abduction) 
- 
Standing internal rotation (at 90°) 
- 
Standing shoulder flexion 
- 
Standing forward punch 
- 
Standing dynamic hug 
- 
Standing W’s (external rotation with 
elbow flexion) 
- 
Standing Biceps curls 
- 
Seated row 
Dynamic strengthening exercises (first weeks 
limit resistance to max 1,5 to 2,5 kg): 
- 
Scapulohumeral rhythm exercises  
- 
Side-lying external rotation at 0° 
- 
Prone row, Scaption “Y”, Extension 
- 
Standing 
forward 
flexion 
1,5-2kg 
(scaption) 
- 
Standing 
external 
rotation 
at 
90° 
abduction 
Intervention of the Control Group  
+  
SWORD 
Phoenix 
exercises 
(adding 
Theraband or weight): 
- 
Scapula Elevation 
- 
Scapula Protraction 
- 
Scapula Retraction 
- 
Shoulder Flexion 
- 
Shoulder External Rotation 
- 
Shoulder Internal Rotation 
- 
Shoulder Abduction 
- 
Shoulder Horizontal Abduction 
- 
Seated Press-up 
- 
Push-up against a wall 
- 
Diagonals to flexion 
- 
Arm circles with 90º flexion 
- 
Arm circles with 90º abduction 
 
Note: * may be less if patient is progressing well 
The rehabilitation program may be extended until 24 weeks, according to the 
orthopaedic surgeon assessment. 

SH-RCT-ARCR-01 Study Protocol 
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Schedule of face-to-face sessions 
 
The following schedule depicts the number of face-to-face sessions according to the 
“normal” protocol, not counting with the exceptions, ie, patient who can proceed to 
the following Phases earlier. 
 
 
Table 4. Face-to-face session schedule 
 
 
Weeks 
Conventional PT 
Experimental 
Immediate Post-op 
Phase 
1 
0 
0 
2 
0 
0 
Phase 1 - 
Immobilization 
Weeks 3 to 4 
3 
2 
1 
4 
2 
1 
Total 
Phase (accumulated) 
 
4 Sessions (4) 
2 Sessions (2) 
Phase 2 - PROM 
Weeks 5 to 9 
5 
3 
2 
6 
3 
2 
7 
3 
2 
8 
3 
2 
9 
3 
1 
Total 
Phase (accumulated) 
 
15 Sessions (19) 
9 Sessions (11) 
Phase 3 – AROM 
Weeks 10 to 14 
10 
3 
1 
11 
3 
1 
12 
3 
1 
13 
3 
1 
14 
3 
1 
Total 
Phase (accumulated) 
 
15 Sessions (34) 
5 Sessions (16) 
Phase 4 – Strength 
Weeks 15 to 20 
15 
3 
1 
16 
3 
0 
17 
3 
1 
18 
3 
0 
19 
3 
1 
20 
3 
0 
Total 
Phase (accumulated) 
 
18 Sessions (52) 
3 Sessions (19) 
 
 
 
 
 

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15. Safety and adverse events 
Patients in the active comparator group will receive face-to-face rehabilitation 
sessions provided by a physical therapist. Therefore, patient safety will be ensured at 
all times during the sessions. Patients will be able to report adverse events to their 
physical therapist. Moreover, the patient´s orthopedic surgeon will be notified in case 
of detrimental clinical progression, so that the patient can be re-evaluated. 
For patients in the experimental group, safety of the remote sessions will be evaluated 
through pain and fatigue scores (graduated from 0 to 10) collected at the end of each 
session. These will be presented to the patient using the mobile App and will be 
available for remote monitoring by their physical therapist. In case of excessive pain 
or fatigue, patients will be contacted by their physical therapist to ascertain the cause 
and change prescription if needed. Patients will also be asked to report any other 
adverse events to their physical therapist by telephone. Moreover, the patient´s 
orthopedic surgeon will be notified in case of detrimental clinical progression, so that 
the patient can be re-evaluated. 
The adverse events will be registered in the patient’s file (beginning date, resolution 
date (if applicable), resolution state, severity). 
 
16. Statistical analysis 
To assess differences in clinical and demographic variables of the patients allocated to 
the two study groups, independent samples t test or Mann–Whitney U test will be 
used for quantitative variables. For qualitative variables, Chi-squared test or Fisher’s 
exact test will be used.  
Outcome analysis will be performed using a per-protocol analysis. The impact of the 
interventions in the primary and secondary outcomes will be evaluated considering 

SH-RCT-ARCR-01 Study Protocol 
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the change between baseline and week 20. Differences between the two study groups 
will be performed using independent samples t test or Mann-Whitney U test.   
Since outcomes will be measured in several different times during the rehabilitation 
program, a repeated measures analysis will also be performed, using a 3x2 ANOVA 
with group as an independent factor and time as a within-subjects factor.  
 
17. Potential Risks and Benefits to Participants 
There are no invasive procedures involved in this research protocol and, given the 
nature of the intervention, no relevant risks are foreseen.  
Both study groups will benefit from a 20-24 week rehabilitation program starting on 
week 2 after surgery. This program will be based on the latest treatment guidelines 
and will therefore represent the state of the art regarding rehabilitation after 
arthroscopic rotator cuff repairs. Thus, both study arms are likely to benefit directly 
from entering the study.  
The experimental group will perform, in addition to the one-to-one physiotherapy 
sessions, a home-based program using SWORD Phoenix. This program will be 
tailored to their specific needs and be accompanied remotely by a physical therapist, 
that will have access to patient performance data, as well as pain and fatigue scores as 
rated by the patient at the end of each session. This allows the therapist to detect 
adverse events and to act promptly. In case of detrimental clinical progression, the 
patient´s orthopedic surgeon will be notified, and the patient will be re-evaluated, to 
decide whether to continue the study. This ensures patients in the experimental group 
are not subject to greater risk. 
Participants will not receive any payments or reimbursements specifically for taking 
part in this study.  

SH-RCT-ARCR-01 Study Protocol 
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Date: 06/14/2018 
18. Confidentiality of Personal Data  
Data collection for this study was authorized by the National Commission on Data 
Protection, with the authorization number 5798/2018.  
Personal data will only be accessible to authorized investigators in this study. 
Personal data will not be entered into the database as part of this research. The clinical 
data collected will only be linked to the patient by a unique study number and will 
contain no personal identifiers. Informed consent will be obtained from participants to 
collect and retain this data. The data that will be used for analysis and dissemination 
for research purposes will be completely anonymized. 
 
19. Ethical issues 
All participants will be provided with information about the purpose and procedures 
of the study and will give written informed consent before inclusion. 
The study was approved by the Ethics Committee of Hospital da Prelada 
(Authorization number 42-26/06/2018). 
 
20. Dissemination of Results  
The results of the study will be published in peer-reviewed scientific journal(s) and 
presented at relevant national and international meetings.  
 
 

SH-RCT-ARCR-01 Study Protocol 
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Date: 06/14/2018 
References 
1.  
Edwards P, Ebert J, Joss B, Bhabra G, Ackland T, Wang A. Exercise 
Rehabilitation in the Non-Operative Management of Rotator Cuff Tears: a 
Review of the Literature. Int J Sports Phys Ther. 2016;11(2):279-301. 
http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=4827371&tool=pm
centrez&rendertype=abstract. 
2.  
Mitchell C, Adebajo A, Hay E, Carr A. Shoulder pain: Diagnosis and 
management in primary care. Bmj. 2005;8(November):331-1124. 
doi:10.1007/BF00320147. 
3.  
Lewis JS. Rotator cuff tendinopathy/subacromial impingement syndrome: Is it 
time for a new method of assessment? Br J Sports Med. 2009;43(4):259-264. 
doi:10.1136/bjsm.2008.052183. 
4.  
Thomson S, Jukes C, Lewis J. Rehabilitation following surgical repair of the 
rotator cuff: a systematic review. Physiotherapy. 2016;102(1):20-28. 
doi:10.1016/j.physio.2015.08.003. 
5.  
Grant HJ, Arthur A, Pichora DR. Evaluation of interventions for rotator cuff 
pathology: A systematic review. J Hand Ther. 2004;17(2):274-299. 
doi:10.1197/j.jht.2004.02.013. 
6.  
Littlewood C, May S, Walters S. Epidemiology of rotator cuff tendinopathy: a 
systematic review. Shoulder Elb. 2013;(December 2012):n/a-n/a. 
doi:10.1111/sae.12028. 
7.  
Bey MJ, Song HK, Wehrli FW, Soslowsky LJ. Intratendinous strain fields of 
the intact supraspinatus tendon: The effect of glenohumeral joint position and 
tendon region. J Orthop Res. 2002;20(4):869-874. doi:10.1016/S0736-
0266(01)00177-2. 
8.  
Littlewood C, Bateman M. Rehabilitation following rotator cuff repair: a 
survey of current UK practice. Shoulder Elb. 2015;7(3):193-204. 
doi:10.1177/1758573215571679. 
9.  
Ross D, Maerz T, Lynch J, Norris S, Baker K, Anderson K. Rehabilitation 
following arthroscopic rotator cuff repair: a review of current literature. J Am 
Acad Orthop Surg. 2014;22(1):1-9. doi:10.5435/JAAOS-22-01-1. 
10.  
Factor D, Dale B. Current concepts of rotator cuff tendinopathy. Int J Sports 
Phys Ther. 2014;9(2):274-288. 

SH-RCT-ARCR-01 Study Protocol 
Version 2.0 
Date: 06/14/2018 
http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=4004132&tool=pm
centrez&rendertype=abstract. 
11.  
Hawkins RJ, Morin WD, Bonutti PM. Surgical treatment of full-thickness 
rotator cuff tears in patients 40 years of age or younger. J Shoulder Elbow 
Surg. 1999;8(3):259-265. http://www.ncbi.nlm.nih.gov/pubmed/10389083. 
12.  
Tempelhof S, Rupp S, Seil R. Age-related prevalence of rotator cuff tears in 
asymptomatic shoulders. J Shoulder Elb Surg. 1999;8(4):296-299. 
doi:10.1016/S1058-2746(99)90148-9. 
13.  
Jackins S. Postoperative shoulder rehabilitation. Phys Med Rehabil Clin N Am. 
2004;15(3):643-682. doi:10.1016/j.pmr.2004.01.002. 
14.  
Christensen BH, Andersen KS, Rasmussen S, Andreasen EL, Nielsen LM, 
Jensen SL. Enhanced function and quality of life following 5 months of 
exercise therapy for patients with irreparable rotator cuff tears - An 
intervention study. BMC Musculoskelet Disord. 2016;17(1):1-8. 
doi:10.1186/s12891-016-1116-6. 
15.  
van der Meijden OA, Westgard P, Chandler Z, Gaskill TR, Kokmeyer D, 
Millett PJ. Rehabilitation after arthroscopic rotator cuff repair: current concepts 
review and evidence-based guidelines. Int J Sports Phys Ther. 2012;7(2):197-
218. 
http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=3325631&tool=pm
centrez&rendertype=abstract. 
16.  
Page M, Green S, Mcbain B, et al. Manual therapy and exercise for rotator cuff 
disease (Review). Cochrane Database Syst Rev. 2016;(6). 
doi:10.1002/14651858.CD012224.www.cochranelibrary.com. 
17.  
Mall NA, Tanaka MJ, Choi LS, Paletta GA. Factors affecting rotator cuff 
healing. J Bone Jt Surg - Am Vol. 2014;96(9):778-788. 
doi:10.2106/JBJS.M.00583. 
18.  
Boissonnault WG, Beth Badke M, Wooden MJ, Ekedahl S, Fly K. Patient 
Outcome Following Rehabilitation for Rotator Cuff Repair Surgery: The 
Impact of Selected Medical Comorbidities. J Orthop Sport Phys Ther. 
2007;37(6):312-319. doi:10.2519/jospt.2007.2448. 
19.  
Mather III RC, Koenig L, Acevedo D, et al. The Societal and Economic Value 
of Rotator Cuff Repair. J Bone Jt Surg. 2013;95:1993-2000. 
20.  
Millett PJ, Wilcox RB, O’Holleran JD, Warner JJ. Rehabilitation of the Rotator 

SH-RCT-ARCR-01 Study Protocol 
Version 2.0 
Date: 06/14/2018 
Approach. J Am Acad Orthop Surg. 2006;14(11):599-609. 
21.  
Dickinson RN, Kuhn JE, Bergner JL, Rizzone KH. A systematic review of 
cost-effective treatment of postoperative rotator cuff repairs. J Shoulder Elb 
Surg. 2017;26(5):915-922. doi:10.1016/j.jse.2017.02.009. 
22.  
Gallagher BP, Bishop ME, Tjoumakaris FP, Freedman KB. Early versus 
delayed rehabilitation following arthroscopic rotator cuff repair: A systematic 
review. Phys Sportsmed. 2015;43(2):178-187. 
doi:10.1080/00913847.2015.1025683. 
23.  
Lee BG, Cho NS, Rhee YG. Effect of two rehabilitation protocols on range of 
motion and healing rates after arthroscopic rotator cuff repair: Aggressive 
versus limited early passive exercises. Arthrosc - J Arthrosc Relat Surg. 
2012;28(1):34-42. doi:10.1016/j.arthro.2011.07.012. 
24.  
Gladstone JN, Bishop JY, Lo IKY, Flatow EL. Fatty infiltration and atrophy of 
the rotator cuff do not improve after rotator cuff repair and correlate with poor 
functional outcome. Am J Sports Med. 2007;35(5):719-728. 
doi:10.1177/0363546506297539. 
25.  
Kluger R, Bock P, Mittlböck M, Krampla W, Engel A. Long-term Survivorship 
of Rotator Cuff Repairs Using Ultrasound and Magnetic Resonance Imaging 
Analysis. Am J Sports Med. 2011;39(10):2071-2081. 
doi:10.1177/0363546511406395. 
26.  
Baumgarten KM, Vidal AF, Wright RW. Rotator cuff repair rehabilitation: A 
level I and II systematic review. Sports Health. 2009;1(2):125-130. 
doi:10.1177/1941738108331200. 
27.  
Gulotta L V., Rodeo SA. Growth Factors for Rotator Cuff Repair. Clin Sports 
Med. 2009;28(1):13-23. doi:10.1016/j.csm.2008.09.002. 
28.  
Mazuquin BF, Wright AC, Russell S, Monga P, Selfe J, Richards J. 
Effectiveness of early compared with conservative rehabilitation for patients 
having rotator cuff repair surgery: An overview of systematic reviews. Br J 
Sports Med. 2016;(0):1-11. doi:10.1136/bjsports-2016-095963. 
29.  
Cuff DJ, Pupello DR. Prospective randomized study of arthroscopic rotator 
cuff repair using an early versus delayed postoperative physical therapy 
protocol. J Shoulder Elb Surg. 2012;21(11):1450-1455. 
doi:10.1016/j.jse.2012.01.025. 
30.  
Kim YS, Chung SW, Kim JY, Ok JH, Park I, Oh JH. Is early passive motion 

SH-RCT-ARCR-01 Study Protocol 
Version 2.0 
Date: 06/14/2018 
exercise necessary after arthroscopic rotator cuff repair? Am J Sports Med. 
2012;40(4):815-821. doi:10.1177/0363546511434287. 
31.  
Kokmeyer D, Dube E, Millett PJ. Prognosis Driven Rehabilitation After 
Rotator Cuff Repair Surgery. Open Orthop J. 2016;10(1):339-348. 
doi:10.2174/1874325001610010339. 
32.  
Mollison S, Shin JJ, Glogau A, Beavis RC. Postoperative Rehabilitation After 
Rotator Cuff Repair: A Web-Based Survey of AANA and AOSSM Members. 
Orthop J Sport Med. 2017;5(1):1-9. doi:10.1177/2325967116684775. 
33.  
Conti M, Garofalo R, Delle Rose G, et al. Post-operative rehabilitation after 
surgical repair of the rotator cuff. Chir Organi Mov. 2009;93 Suppl 1:S55-63. 
doi:10.1007/s12306-009-0003-9. 
34.  
Klintberg I, Hultenheim ACG, Svantesson U, Styf J, Karlsson J. Early loading 
in physiotherapy treatment after full-thickness rotator cuff repair: A 
prospective randomized pilot-study with a two-year follow-up. Clin Rehabil. 
2009;23(7):622-638. doi:10.1177/0269215509102952. 
35.  
Rokito AS, Zuckerman JD, Gallagher MA, Cuomo F. Strength after surgical 
repair of the rotator cuff. J Shoulder Elb Surg. 1996;5(1):12-17. 
doi:10.1016/S1058-2746(96)80025-5. 
36.  
Düzgün I, Baltaci G, Turgut E, Atay OA. Effects of slow and accelerated 
rehabilitation protocols on range of motion after arthroscopic rotator cuff 
repair. Acta Orthop Traumatol Turc. 2014;48(6):642-648. 
doi:10.3944/AOTT.2014.13.0125. 
37.  
De Roo P-J, Muermans S, Maroy M, Linden P, Van den Daelen L. Passive 
mobilization after arthroscopic rotator cuff repair is not detrimental in the early 
postoperative period. Acta Orthop Belg. 2015;81(3):485-492. 
http://www.ncbi.nlm.nih.gov/pubmed/26435245. 
38.  
Keener JD, Galatz LM, Stobbs-Cucchi G, Patton R, Yamaguchi K. 
Rehabilitation Following Arthroscopic Rotator Cuff Repair. J Bone Jt Surgery-
American Vol. 2014;96(1):11-19. doi:10.2106/JBJS.M.00034. 
39.  
Miller BS, Downie BK, Kohen RB, et al. When do rotator cuff repairs fail? 
Serial ultrasound examination after arthroscopic repair of large and massive 
rotator cuff tears. Am J Sports Med. 2011;39(10):2064-2070. 
doi:10.1177/0363546511413372. 
40.  
Arndt J, Clavert P, Mielcarek P, Bouchaib J, Meyer N, Kempf JF. Immediate 

SH-RCT-ARCR-01 Study Protocol 
Version 2.0 
Date: 06/14/2018 
passive motion versus immobilization after endoscopic supraspinatus tendon 
repair: A prospective randomized study. Orthop Traumatol Surg Res. 
2012;98(SUPPL. 6):S131-S138. doi:10.1016/j.otsr.2012.05.003. 
41.  
Riboh J, Garrigues GE. Early passive motion versus immobilization after 
arthroscopic rotator cuff repair. Arthrosc  J Arthrosc Relat Surg. 2014;30(8):1-
9. doi:10.1016/j.arthro.2014.03.012. 
42.  
Düzgün I, Baltaci G, Ahmet Atay Ö. Comparison of slow and accelerated 
rehabilitation protocol after arthroscopic rotator cuff repair: Pain and functional 
activity. Acta Orthop Traumatol Turc. 2011;45(1):23-33. 
doi:10.3944/AOTT.2011.2386. 
43.  
Denard PJ, Lädermann A, Burkhart SS. Prevention and Management of 
Stiffness After Arthroscopic Rotator Cuff Repair: Systematic Review and 
Implications for Rotator Cuff Healing. Arthrosc J Arthrosc Relat Surg. 
2011;27(6):842-848. doi:10.1016/j.arthro.2011.01.013. 
44.  
Koh KH, Lim TK, Shon MS, Park YE, Lee SW, Yoo JC. Effect of 
immobilization without passive exercise after rotator cuff repair: Randomized 
clinical trial comparing four and eight weeks of immobilization. J Bone Jt Surg 
- Ser A. 2014;96(6):1-9. doi:10.2106/JBJS.L.01741. 
45.  
Mazzocca AD, Arciero RA, Shea KP, et al. The Effect of Early Range of 
Motion on Quality of Life, Clinical Outcome, and Repair Integrity After 
Arthroscopic Rotator Cuff Repair. Arthrosc J Arthrosc Relat Surg. 
2017;33(6):1138-1148. doi:10.1016/j.arthro.2016.10.017. 
46.  
Roddey T, Olson SL, Gartsman GM, Hanten WP, Cook KF. A Randomized 
Controlled Triaç Comparing 2 Instructionl Approaches to Home Exercise 
Instruction Following Arthroscopic Full-Thickness Rotator Cuff Repair 
Surgery. J Orthop Sports Phys Ther. 2002;32:548-559. 
47.  
Hayes K, Ginn KA, Walton JR, Szomor ZL, Murrell GAC. A randomised 
clinical trial evaluating the efficacy of physiotherapy after rotator cuff repair. 
Aust J Physiother. 2004;50(2):77-83. doi:10.1016/S0004-9514(14)60099-4. 
48.  
Kweon C, Gagnier JJ, Robbins CB, Bedi A, Carpenter JE, Miller BS. Surgical 
Versus Nonsurgical Management of Rotator Cuff Tears. Am J Sports Med. 
2015;43(10):2368-2372. doi:10.1177/0363546515593954. 
49.  
Wylie JD, Beckmann JT, Granger E, Tashijan RZ. Functional outcomes 
assessment in shoulder surgery. World J Orthop. 2014;5(5):623-633. 

SH-RCT-ARCR-01 Study Protocol 
Version 2.0 
Date: 06/14/2018 
doi:10.5312/wjo.v5.i5.623. 
50.  
Romeo AA, Mazzocca A, Hang DW, Shott S, Bach BR. Shoulder Scoring 
Scales for the Evaluation of Rotator Cuff Repair. 2004;(427):107-114. 
doi:10.1097/01.blo.0000142624.05526.dd. 
51.  
Skutek M, Fremerey RW, Zeichen J, Bosch U. Outcome analysis following 
open rotator cuff repair. Early effectiveness validated using four different 
shoulder assessment scales. 2000;120:432-436. 
52.  
Roy J-S, Esculier J-F. Psychometric evidence for clinical outcome measures 
assessing shoulder disorders. Phys Ther Rev. 2011;16(5):331-347. 
doi:10.1179/1743288X11Y.0000000043. 
53.  
Sabesan VJ, Lombardo DJ, Khan J, Wiater JM. Assessment of the optimal 
shoulder outcome score for reverse shoulder arthroplasty. J Shoulder Elb Surg. 
2015:1-7. doi:10.1016/j.jse.2015.03.030. 
54.  
Macdermid JC, Birmingham TB, Khadilkar L, Athwall GS. Validity of the 
QuickDASH in Patients With Shoulder-Related Disorders Undergoing 
Surgery. Joournal Orthop Sport Phys Ther. 2015;45(1):25-36. 
doi:10.2519/jospt.2015.5033. 
55.  
Constant CR, Gerber C, Emery RJH, Søjbjerg JO, Gohlke F, Boileau P. A 
review of the Constant score: Modifications and guidelines for its use. J 
Shoulder Elb Surg. 2008;17(2):355-361. doi:10.1016/j.jse.2007.06.022. 
56.  
Kukkonen J, Kauko T, Vahlberg T, Joukainen A, Aarimaa V. Investigating 
minimal clinically important difference for Constant score in patients 
undergoing rotator cuff surgery. J Shoulder Elb Surg. 2013;22:1650-1655. 
doi:10.1016/j.jse.2013.05.002. 
57.  
Booker S, Alfahad N, Scott M, Gooding B, Wallace WA. Use of scoring 
systems for assessing and reporting the outcome results from shoulder surgery 
and arthroplasty. World J Orthop. 2015;6(2):244-251. 
doi:10.5312/wjo.v6.i2.244. 
58.  
Beaton DE, Wright JG, Katz JN. Development of the QuickDASH : 
Comparison of Three Item-Reduction Approaches. J Bone Jt Surg. 2005;87-
A(5):1038-1046. 
59.  
Franchignoni F, Vercelli S, Giordano A, Sartorio F, Bravini E, Ferriero G. 
Minimal Clinically Important Difference of the Disabilities of the Arm, 
Shoulder and Hand Outcome Measure (DASH) and Its Shortened Version 

SH-RCT-ARCR-01 Study Protocol 
Version 2.0 
Date: 06/14/2018 
(QuickDASH). J Orthop Sport Phys Ther. 2014;44(1):30-39. 
doi:10.2519/jospt.2014.4893.