Efficacy of a Home-based Rehabilitation Program Performed Through a Digital Kinematic Biofeedback System After Total Hip or Knee Replacement: a Single-arm, Prospective, Open-label Study
Phase: NA
Conditions: Hip Osteoarthritis, Knee Osteoarthritis
Sponsor: Sword Health, SA

 
 
 
 
 
 
 
 
 
 
Clinical Study Protocol 
  
 
  
Study ID: SH-SA-THKR-01 
  
Efficacy of a Digital Biofeedback System for Home-based Rehabilitation 
After Total Joint Replacement 
 
Study registration number: NCT03648060 
 
Document Version: 1.0 
  
Date: 06/14/2018 
  
  
Study promotor: SWORD Health, SA 
 

 
Revision History 
   
Version 
Date 
Description 
Author 
1.0 
06/13/2018 
Original 
FDC 
  
 
Investigators 
  
Fernando Emanuel Dias Correia 
Rua de Sá da Bandeira, Nº 651 1º Direito 
4000-437 Porto 
Contacto: 966557789 
Email: fcorreia@swordhealth.com 
 
Rosmaninho Seabra 
Rua Sarmento Beires 153 
4250-449 Porto 
Email: rosmaninho.seabra@hospitaldaprelada.pt 
 
José Tulha 
Rua Sarmento Beires 153 
4250-449 Porto 
Email: jose.tulha@hospitaldaprelada.pt 
 
Joaquim Pires 
Rua Sarmento Beires 153 
4250-449 Porto 
Email: joaquim.pires@hospitaldaprelada.pt 
 
 
 
Research Center 
 
Hospital da Prelada- Dr. Domingos Braga da Cruz 
Rua Sarmento Beires 153 
4250-449 Porto 
 
 

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1. Introduction 
 
The effects of total hip (THA) and knee (TKA) arthroplasty are well documented, with 
the majority of patients showing significant pain relief and relevant functional 
improvement 1–3. It is also proven that rehabilitation after THA or TKA maximizes 
results 4–6. As such, rehabilitation is widely prescribed upon surgery.  
There are no universally accepted guidelines for rehabilitation after THA or TKA 7–10. 
Moreover, clinical evidence on this matter is limited, with variable quality and 
sometimes inconsistent 10.  
Importantly, the exact composition and duration of physical therapy is not 
standardized 11,12. This fact is particularly relevant considering that the rehabilitation 
program may influence both short- and long-term results 13–18. There are no defined 
optimal doses of physical exercise, nor ideal progression curves for therapist’s 
guidance 10. Notwithstanding, studies suggest that intensive and progressive 
rehabilitation translates into better results 4, also maximizing patient’s adhesion to 
therapy and overall satisfaction 8. 
According to an expert consensus on best practices for post-acute rehabilitation 
after THA and TKA, rehabilitation should start within 3 weeks of discharge 10. Despite 
the absence of criteria on specific dose parameters of duration, frequency, and 
number of treatment sessions, the recommendations support 4 to 12 weeks of 
supervised rehabilitation, 2 to 3 times per week 10. There is also evidence stating that 
therapeutic exercise should be a primary component of post-operative care, and 
that the exercise programs should be supervised and progressed as the patients 
meet clinical and strength milestones 9,13.   
Regarding the rehabilitation setting, home-based and clinic-based rehabilitation 
protocols have generated similar improvements 7,19–24. Also, tele-rehabilitation has 
demonstrated similar outcomes in comparison to standard rehabilitation 21,22,25.  
These findings are in line with recent trends in healthcare delivery, away from 
inpatient care and towards home-based care, towards cost-effectiveness 
improvement. Optimizing uptake and adherence is of paramount importance 26, and 
this can be maximized by home-based care 27. 

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In this sense, 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. 
Hence, we created SWORD Phoenix, a novel digital biofeedback system for home-
based physical rehabilitation. SWORD Phoenix® is a class I medical device that, using 
inertial motion trackers, 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. 
 
The efficacy of SWORD Phoenix has already been demonstrated in two previous 
feasibility studies conducted at Hospital da Prelada, Porto, Portugal, between 
December 2016 and March 2018 (Clinical trial IDs: NCT03047252 and NCT03045549). 
These were two parallel-group studies, comparing the clinical evolution of patients 
submitted to an 8-week rehabilitation program after THA or TKA, divided into two 
distinct groups: the experimental group, which performed a home-based 
rehabilitation program using SWORD Phoenix, and the control group, which was also 
engaged in a home-based rehabilitation program, but with conventional 
physiotherapy instead. Geographical location was used as the allocation criterion, 
with patients living within the city´s administrative limits allocated to the 
conventional physiotherapy group and patients living outside the city´s 
administrative limits allocated to the experimental group. Results from the 
experimental group where superior to those from the conventional physiotherapy 
group in all outcome measures, and adverse effects rates where similar in both 
groups. The main results of the TKA study were already published 28, and the main 
results of the THA study are in publication route. 
More recently, a new version of the system was developed, where the possibility to 
execute bilateral exercises was added, focusing not only on the rehabilitation of the 
affected limb, but also on muscular reinforcement of the contralateral limb. As such, 

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a new clinical study was designed, aiming at exploring the clinical impact of this 
update on the therapeutic program (bilateral). 
 
The present study is a single-center, prospective, single-arm, historical control study, 
designed to evaluate the clinical outcomes of a bilateral home-based rehabilitation 
program using SWORD Phoenix®. The clinical outcomes will be compared to those of 
the above-mentioned feasibility studies. The investigation hypothesis is that the 
clinical outcomes of the bilateral exercise program will be superior to those of the 
unilateral exercise program. 
 
2. Study Outcomes 
The aim of the studies is to evaluate the clinical impact of a home-based bilateral 
rehabilitation program after THA or TKA, using SWORD Phoenix®. 
 
a) Primary outcome 
The primary outcome will be the change in patient performance compared to the 
baseline, measured through the TUG.  
 
b) Secondary outcomes 
- 
The change in patient reported outcomes, measured by HOOS and KOOS 
scales, as compared to baseline evaluation  
- 
The change in the maximum amplitude of joints movements, as 
compared to baseline evaluation  
 
3. Sample size estimate 
Sample size estimation calculations were performed taking into consideration the 
primary outcome measure - Timed up and Go (TUG) test score. Calculations were 
based on the baseline TUG distribution of the participants in the two previous 
feasibility studies (total n=131; mean 18,00 seconds; sd=6,3) and on a Minimal 
Clinical Significant Change of 2.27 seconds as reported by Yuksel et al.29. 

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Considering a power of 80%, a two-sided 0.05 significance level and an allocation 
rate of 2:1, 216 patients (144 in this study; 72 historical control) would be necessary 
to detect a 2.27 seconds difference against the historical control.  
 
 
4. Inclusion criteria 
a) Patients over 18 years old 
b) Clinical and imaging evidence of hip/knee osteoarthritis 
c) Indication for total hip or knee replacement according to the patient´s 
orthopedic surgeon 
d) Ability to walk unaided, with unilateral or bilateral support 
e) Availability of a caregiver to assist the patient after surgery 
 
5. Exclusion criteria 
a) Patients admitted for revision of total hip/knee replacement 
b) Contralateral hip or knee osteoarthritis severely limiting patient mobility and 
ability to comply with a rehabilitation program 
c) Aphasia, dementia or psychiatric comorbidity interfering with the 
communication or compliance to the rehabilitation process 
d) Respiratory, cardiac, metabolic or other condition incompatible with at least 
30 minutes of light to moderate physical activity 
e) Major medical complications occurring after surgery that prevent the 
discharge of the patient within 10 days after the surgery 
f) Other medical and/or surgical complications that prevent the patient from 
complying with a rehabilitation program 
g) Blind and/or illiterate patients 
h) Patients residing outside a 30km radius from the investigation center 
 
6. Methods for identifying and recruiting patients  
All patients admitted for total hip or knee replacement during the study period will 

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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 
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. 
 
7. Informed consent 
Informed consent will be delivered in paper format (see annex), informing 
individuals of their free will to drop out of the study, without any prejudice to their 
health assistance or medical attention. It includes information on collected data 
confidentiality and its publication potential in scientific journals, respecting all due 
ethical standards.  
Finally, it assures the individual that he was correctly informed about the study, 
requiring the signature from both the patient and one of the study researchers. 
 
8. Data anonymization 
Numerical codes will be attributed to each study participant. As soon as possible, all 
the information from the questionnaires will be transferred to digital data bases and 
the documents kept in a specific location at SWORD Health, SA headquarters, with 
restricted access. 
 
9. Scales and assessment tools 
Several studies suggest that the outcomes should be measured not only in terms of 
range of motion, which is considered a poor marker of implant success and patient 
satisfaction 9,30–32 but also using patient-reported outcomes and a performance test 
33,34. As such, results will be evaluated according to three outcome measures: a) a 
performance test; b) patient-reported outcomes (using HOOS and KOOS scales); c) 

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range of motion of the hip or knee. 
 
a) Performance test 
Timed up and Go (TUG) test was selected as a performance test, which 
measures the time the patient takes to rise up from a chair, walk three 
meters, turn around, walk again towards the chair and sit. This test was 
chosen as it is simple and practical, quick and easy to administer, has high 
inter-rater reliability 35 and has been demonstrated to predict both short- 36 
and long-term 37,38 function, following arthroplasty. 
Instructions to perform the test: 
1) Select a chair with armrests and a seating height of 44-47 cm  
2) Measure 3 meters in a straight line from the chair and place a mark on the 
floor 
3) Ask the patient to sit in a chair with his/her back against the chair back 
4) Instruct the patient to rise from the chair on the command “go”, walk 3 
meters at a comfortable and safe pace, turn, walk back to the chair and sit 
down 
5) Begin timing at “go” and stop when the patient is seated 
6) Register the time with two decimal digits in the patient file 
 
b) Patient reported outcomes scales  
b.1. Hip Osteoarthritis Outcome Scale (HOOS) 
The HOOS scale was validated for patients submitted to THA by Nilsdotter 
and colleagues 
39. The HOOS consists of 5 subscales: 1) Pain; 2) 
other Symptoms; 3) Function in daily living (ADL); 4) Function in sport and 
recreation (Sport/Rec) and 5) hip related Quality of life (QOL). The previous 
week is the time period considered when answering the questions. 
Standardized options are given and each question is assigned a score from 0 
to 4 (5 Likert boxes). A normalized score (100 indicating no symptoms and 0 
indicating extreme symptoms) is calculated for each subscale. 

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A copy of the questionnaire can be found in each patient file. To administer 
the questionnaire sheet, the investigator must extract it from the study file 
and hand it over to the patient, so he can fill in the form. The patient cannot 
be assisted in performing the movement at any time. Once finished, the 
sheet must be signed and dated by the investigator, and archived in the 
patient file.  
 
b.2. Knee Osteoarthritis Outcome Score (KOOS) 
The KOOS scale 40 was validated for patients submitted to TKA by Alviar and 
colleagues 41. The KOOS consists of 5 subscales: 1) Pain; 2) other Symptoms; 
3) Function in daily living (ADL); 4) Function in sport and recreation 
(Sport/Rec) and 5) knee related Quality of life (QOL). The previous week is the 
time period considered when answering the questions. Standardized options 
are given and each question is assigned a score from 0 to 4. A normalized 
score (100 indicating no symptoms and 0 indicating extreme symptoms) is 
calculated for each subscale. 
A copy of the questionnaire can be found in each patient file. To administer 
the questionnaire sheet, the investigator must extract it from the study file 
and hand it over to the patient, so he can fill in the form. The patient cannot 
be assisted in performing the movement at any time. Once finished, the 
sheet must be signed and dated by the investigator, and archived in the 
patient file.  
 
c) Range of motion of the hip and knee 
Hip and knee range of motion will be assessed based in three distinct positions: 
lying, sitting and standing. The system used in the study is a validated medical 
device for joint angle measurement. Therefore, knee range of motion will be 
measured automatically by the system. 
In this study, the active range of motion will be measured through the following 
movements: 
 

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Knee: 
Lying knee flexion 
Sitting knee flexion 
Standing knee flexion 
Sitting knee extension 
 
Hip: 
Lying hip flexion 
Lying hip abduction 
Standing hip flexion 
Standing hip abduction 
Standing hip hyperextension 
 
 
To assess range of motion, the investigator will need to: 
1) Create a patient profile in the Portal 
2) Prescribe one set of each exercise, with 5 repetitions 
3) Ask the patient to perform the session through the App, executing each 
repetition to the best of his ability 
4) After the session, login to the Portal, go to the session´s results and click on 
detailed results for each exercise. Record the flexion or extension angle of the 
best repetition for each exercise in the patient file. 
 
10. Patient assessment 
Patients will be assessed at baseline (pre-operatively) (A1), upon discharge (A2), at 4 
weeks after rehabilitation program initiation (A3), and at the end of it (A4). 
Assessments will be performed within a time window of 5-working-days, previous or 
ahead of the day the assessment was scheduled for.  
 
Baseline assessment (A1) 
Participant characterization will consist of:  
- 
Demographics (gender, age at enrollment);  
- 
Educational level (years at school); 
- 
Diagnosis and affected side 
- 
Date of surgery 

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- 
Height, weight, body Mass Index 
- 
Comorbidities 
• Smoking 
• Diabetes 
• Cardiac disease 
• Respiratory disease 
• Hypertension 
• Stroke 
• Renal Disease 
• Bleeding disorders 
• Previous hip/knee replacement 
• American Society of Anesthesiologists physical status classification 
score of 3 or 442 
b) HOOS/KOOS score  
c) Timed Up and Go (TUG) test score 
d) Hip and knee active range of motion 
 
Assessment upon discharge (A2) 
Patients will be reevaluated immediately upon hospital discharge, and the following 
parameters will be registered: 
- 
Surgery date 
- 
Operative time 
- 
Type of prosthesis  
- 
Adverse effects before discharge 
 
Subsequent assessments (A3 e A4) 
Patients will be reassessed at 4 and 8 weeks after rehabilitation program initiation, 
collecting the following data: 
- 
TUG score 
- 
HOOS / KOOS score 
- 
Maximum range of motion of the affected joint 

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11. Intervention 
Upon hospital discharge, all participants will have immediate access to home-based 
rehabilitation therapy. 
The rehabilitation program will be carried out at home, using SWORD Phoenix®. 
Patients will be instructed to engage on their rehabilitation sessions daily, but will 
not be excluded from the study in case this periodicity is not respected. 
The rehabilitation programs proposed are presented in Tables 1 to 4. 
 
 
Table 1: Hip replacement rehabilitation protocol - Stage 1 (weeks 0-5) 
 

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Stage 1 (weeks 0-4) 
Objectives 
Precautions 
Decrease pain and swelling 
 
Restore range of motion 
 
Strengthen hip flexors and abductors 
 
Restore fully load capacity on both legs  
Avoid hip internal rotation and hip adduction 
beyond neutral 
 
Avoid hip flexion above 90º 
 
Ice pack application after each session and 
throughout the day as needed 
Intervention 
Open kinetic chain exercises without added resistance 
 
Lying: 
- 
Bilateral Hip Flexion (1x20-24 reps) 
- 
Operated Limb Hip Flexion (1x12-14 reps) 
- 
Bilateral Hip Abduction (1x20-24 reps) 
- 
Operated Limb Hip abduction (1x20-24 reps) 
- 
Bilateral Knee flexion (1x20-24 reps) 
- 
Operated Limb Knee Flexion (1x12-14) 
 
Standing (initially with support) 
- 
Bilateral Hip Flexion (1x20-24 reps) 
- 
Operated Limb Hip Flexion (1x12-14 reps) 
- 
Bilateral Hip Abduction (1x20-24 reps) 
- 
Operated Limb Hip abduction (1x12-14 reps) 
- 
Bilateral Knee flexion (1x20-24 reps) 
- 
Operated Limb Knee Flexion (1x12-14 reps) 
- 
Bilateral Hip Flexion with Knee Flexion (1x20-24) 
- 
Operated Limb Hip flexion with knee flexion (1x12-14 reps) 
- 
Bilateral Hip hyperextension (1x20-24 reps) 
- 
Operated Limb Hip Hyperextension (1x12-14 reps) 
 
Closed kinetic chain exercises 
- 
Bridge (2x12-14) 
- 
Squats (2x12-14reps) 
 
Note 1: adjust sets, reps and total session duration according to patient tolerance (based on patient 
performance and on the pain and fatigue scores attributed by the patient at the end of each session) 
 

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Note 2: aim for at least 30 minutes in total 
 
Note 3: recommend two daily sessions as soon as tolerated 
 
 
Table 2: Hip replacement rehabilitation protocol - Stage 2 (weeks 6-8) 
 

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Stage 2 (weeks 5-8) 
Objectives 
Precautions 
Strengthening of hip flexors and abductors 
 
Improve balance 
 
Independence on all activities of daily living 
 
Identical to stage 1 
Intervention 
Open kinetic chain exercises in the lying, sitting and standing positions 
 
Lying: 
- 
Bilateral Hip Flexion (1x26-30 reps) 
- 
Operated Limb Hip Flexion (1x17-20 reps) 
- 
Bilateral Hip Abduction (1x26-30 reps) 
- 
Operated Limb Hip abduction (1x17-20 reps) 
- 
Bilateral Knee flexion (1x26-30 reps) 
- 
Operated Limb Knee Flexion (1x17-20 reps) 
- 
Bilateral Hip Flexion with Knee Flexion (1x26-30 reps) 
- 
Operated Limb Hip flexion with knee flexion (1x17-20 reps) 
 
Standing 
- 
Bilateral Hip Flexion (1x26-30 reps) 
- 
Operated Limb Hip Flexion (1x17-20 reps) 
- 
Bilateral Hip Abduction (1x26-30 reps) 
- 
Operated Limb Hip abduction (1x17-20 reps) 
- 
Bilateral Knee flexion (1x26-30 reps) 
- 
Operated Limb Knee Flexion (1x17-20 reps) 
- 
Bilateral Hip Flexion with Knee Flexion (1x26-30 reps) 
- 
Operated Limb Hip flexion with knee flexion (1x17-20 reps) 
- 
Bilateral Hip hyperextension (1x26-30 reps) 
- 
Operated Limb Hip Hyperextension (1x17-20 reps) 
 
Closed kinetic chain exercises 
- 
Bridge (2x17-20 reps) 
- 
Squats (2x17-20 reps) 
- 
Bilateral Stand to Sit (2x12reps) 
- 
Bilateral Wall Sit  (2x15-30secs) 
 
Functional exercises 
- 
Bilateral Forward Lunge (1x20-24reps) 
- 
Operated Limb Forward Lunge (1x12-14 reps) 

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- 
Bilateral Climb a Step (1x20-24reps) 
- 
Operated Limb Climb a Step (1x12-14 reps) 
- 
Bilateral Come down a Step (1x20-24reps) 
- 
Operated Limb Come down a Step (1x12-14 reps) 
 
Note 1: adjust sets, reps and total session duration according to patient tolerance (based on patient 
performance and on the pain and fatigue scores attributed by the patient at the end of each session) 
 
Note 2: maintain recommendation of two sessions/day 
 
 
 
 
Table 3: Knee replacement rehabilitation protocol - Stage 1 (weeks 0-4) 
 

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Stage 1 (weeks 0-4) 
Objectives 
Precautions 
Decrease pain and swelling 
Gain range of motion 
Strengthen knee extensors and flexors 
Restore fully load capacity on both legs  
Beware with the tissues on the surgical wound 
 
Ice pack application after each session and 
throughout the day as needed 
Intervention 
Recommendations of good practices on the TKR procedure on the deploy day  
 
Open kinetic chain exercises without added resistance 
 
Lying 
- 
Bilateral Hip Flexion (1x20-24 reps) 
- 
Operated Limb Hip Flexion (1x12-14 reps) 
- 
Bilateral Hip Abduction (1x20-24 reps) 
- 
Operated Limb Hip abduction (1x12-14 reps) 
- 
Bilateral Knee flexion (1x20-24 reps) 
- 
Operated Limb Knee Flexion (1x12-14 reps) 
- 
Lateral decubitus Hip Abduction (2x10-12reps) 
- 
Clamshells (2x10-12 reps) 
- 
Bridge (2x10-12reps) 
 
Sitting 
- 
Bilateral Knee Flexion (1x20-24 reps) 
- 
Operated Limb Knee flexion (1x12-14 reps) 
- 
Bilareal Knee Extension  (1x20-24 reps) 
- 
Operated Limb Knee extension (1x12-14 reps) 
 
Standing (initially with support) 
- 
Hip abduction (2x10 reps) 
- 
Hip hyperextension (2x10 reps) 
- 
Knee flexion (2x10 reps) 
- 
Hip flexion with knee flexion (2x10 reps) 
 
Closed kinetic chain 
- 
Mini-squats (2x10 reps) 
- 
Bridge (2x10 reps) 
 

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Note 1: adjust sets, reps and total session duration according to patient tolerance based on the pain 
and fatigue attributed (aim for at least 30 minutes in total) 
 
Note 2: recommend two daily sessions as soon as tolerated 
 
 
 
Table 4: Knee replacement rehabilitation protocol - Stage 2 (weeks 5-8) 

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Stage 2 (weeks 5 - 8) 
Objectives 
Precautions 
Strengthening of knee flexors and extensors 
Increase active range of motion 
Improve balance 
Independence on all activities of daily living 
Same as stage 1 
Intervention 
Open kinetic chain exercises in the lying, sitting and standing positions: 
 
Lying: 
- 
Bilateral Hip Flexion (1x26-30 reps) 
- 
Operated Limb Hip Flexion (1x17-20 reps) 
- 
Bilateral Hip Abduction (1x26-30 reps) 
- 
Operated Limb Hip abduction (1x17-20 reps) 
- 
Bilateral Knee flexion (1x26-30 reps) 
- 
Operated Limb Knee Flexion (1x17-20 reps) 
- 
Lateral decubitus Hip Abduction (2x15-20reps) 
- 
Clamshells (2x15-20 reps) 
 
Sitting 
- 
Bilateral Knee Flexion (1x26-30 reps) 
- 
Operated Limb Knee flexion (1x17-20 reps) 
- 
Bilareal Knee Extension  (1x26-30 reps) 
- 
Operated Limb Knee extension (1x17-20 reps) 
 
Standing 
- 
Bilateral Hip Flexion (1x26-30 reps) 
- 
Operated Limb Hip Flexion (1x17-20 reps) 
- 
Bilateral Hip Abduction (1x26-30 reps) 
- 
Operated Limb Hip abduction (1x17-20 reps) 
- 
Bilateral Knee flexion (1x26-30 reps) 
- 
Operated Limb Knee Flexion (1x17-20 reps) 
- 
Bilateral Hip hyperextension (1x26-30 reps) 
- 
Operated Limb Hip Hyperextension (1x17-20 reps) 
 
Closed kinetic chain exercises 
- 
Bridge (2x17-20 reps) 
- 
Squats (2x17-20 reps) 
- 
Bilateral Stand to Sit (2x12reps) 
- 
Bilateral Wall Sit  (2x15-30secs) 
 

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Functional exercises 
- 
Bilateral Climb a Step (1x20-24reps) 
- 
Operated Limb Climb a Step (1x12-14 reps) 
- 
Bilateral Come down a Step (1x20-24reps) 
- 
Operated Limb Come down a Step (1x12-14 reps) 
 
Note 1: adjust sets, reps and total session duration according to patient tolerance based on the pain 
and fatigue attributed (aim for at least 45 minutes in total) 
 
Note 2: maintain recommendation of two sessions/day 

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In any case, these protocols can be tailored to the patient´s specific needs, according 
to the joint assessment between the orthopedic surgeon and the physical therapist. 
The rehabilitation process will be remotely accompanied by SWORD Health clinical 
team, with phone calls and home visits to the patient whenever needed.  
 
12. Home visits 
Each of the participants will be assigned a physiotherapist, who will pay an initial 
visit to teach the patient how to operate the system, as well as to prescribe an 
exercise program based on the presented guidelines and adapted to the patient´s 
specific needs. The therapist will perform an initial session with the patient, ensuring 
that the patient is able to perform each exercise and that he can operate the system, 
alone or with the help of a caregiver. 
From here on, the patient will be followed remotely by the physiotherapist, with no 
home sessions. On the 4th week of therapy, each participant will receive an interim 
visit, in which the therapist will assess patient progress and adjust the rehabilitation 
program accordingly. This visit will not consist of a face-to-face session. 
Additionally, a progress assessment phone call will be performed every two weeks 
(at weeks 2 and 6). 
Extraordinary visits or phone call may be performed in case of necessity. Whenever 
it happens, these events will be recorded on patient’s file (date, occurrence, 
duration)  
 
13. Safety and adverse events 
Patient safety will be ensured at all times during the sessions, and 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. Patients will also be asked to report any other 
adverse events to their physical therapist by telephone, and these will be registered 
on the patient’s file (date of the event, date of resolution - if applicable, resolution 

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state, gravity). 
 
14. Risks and Benefits to Participants  
All participant will benefit from therapeutic rehabilitation immediately upon hospital 
discharge. Thus, the access to rehabilitation care is assured, which will likely 
translate into potential benefits for the patient. Patients will engage in a home-
based rehabilitation program through SWORD Phoenix®, according to the latest 
treatment 
guidelines 
and 
following 
the 
clinician’s 
recommendations. 
A 
physiotherapist will be allocated to each patient, guaranteeing a continuous follow 
up and home visits whenever necessary. Since the system will be used in line with its 
certified therapeutic indications, there will be no added risk or inconvenient to the 
user. In fact, the rate of adverse events reported on previous clinical trials was 
identical to that reported with conventional physiotherapy. Hence, participants are 
not exposed to any added risk, being able instead to directly benefit from a 
breakthrough technology, that allows a real and immediate measure of their 
performance, increasing their motivation and maximizing rehabilitation outcomes 
even further. 
 
15. Results analysis 
Per-protocol and intention-to-treat analysis will be applied to evaluate the study 
outcomes. Participants with an adhesion rate below 43% (corresponding to less than 
3 sessions per week) will not be considered in the per-protocol analysis. 
Intervention’s impact on primary and secondary outcomes will be performed 
considering the variables evolution when comparing basal assessment and 
assessment at 8 weeks. 
 
16. Confidentiality of Personal Data  
Data collection for this study was authorized by the National Commission on Data 
Protection, with the authorization number 1476/2017. 
Personal data will only be accessible to authorized individuals in this study. Personal 
data will not be entered into the database as part of this research. The clinical data 

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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. 
 
17. Ethical issues 
All participants will be provided with information about the purpose and procedures 
of the study and gave written informed consent before inclusion. 
The study was approved by the local ethics committee (Chair: Dr. Juiz Conselheiro 
Almeida Lopes) and will be conducted in accordance with the relevant guidelines and 
regulations. 
 
18. System technical specifications 
SWORD Phoenix® system is composed of the following three interconnected 
components: 
 
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 trackers: on the lateral surface of the leg, approximately midway 
between the trochanter and the lateral epicondyle 
- 
Blue trackers: on the upper third of the antero-medial surface of the tibia 
 
Mobile App 
The mobile app guides the patient in each exercise session. Before each exercise, the 
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 progress bar; b) 
a repetition counter; c) a star counter and d) a timer displaying time left in the 

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exercise. 
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 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 5 stars, depending on the 
range of motion of that specific movement in comparison to normative values for 
that movement. 
At the end of each session, the patient is presented with a summary of the number 
of completed repetitions and stars, as well as with badges rewarding him for the 
progresses achieved in each exercise. 
 
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. To prescribe a session, 
the clinician needs to select the exercises, number of sets and number of repetitions.  
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 exercise according to patient performance and progress. 
  
 

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The investigators: 
 
 
 
_________________________________________ 
Dr. Rosmaninho Seabra 
 
 
_________________________________________ 
Dr. Fernando Dias Correia