Clinical Impact of a Digital Home-based Falls Prevention Program on Elderly People - a Randomized Controlled Trial
Phase: NA
Conditions: Fall
Sponsor: Sword Health, SA

 
 
 
 
 
 
 
 
 
Study Protocol 
 
 
 
 
Study ID:  RCT-FP-01 
 
 
Title: Clinical impact of a digital home-based falls prevention 
program on elderly people – a randomized controlled trial 
 
Document Version: 1.3 
 
Date: 11/14/2018 
 
 
Sponsor: SWORD Health, SA 
 
Funding: P2020 Program 
Research and Technological Development: I&D Individual Projects 
– SWORD Care Project 
 
 

RCT-FP-01 Study Protocol 
 
 
 
Version 1.3 
Date: 11/14/2018 
Revision History 
 
Version 
Date 
Description 
Author 
1.0 
25/01/2018 
Original version in Portuguese 
FDC 
1.1 
16/04/2018 
Translation to English 
JG 
1.2 
18/04/2018 
Content revision 
FDC 
1.3 
14/11/2018 
Content revision 
MM 
 
 
Principal Investigator 
 
Fernando Emanuel Dias Correia 
Rua de Sá da Bandeira, number 651 1st right 
4000-437 Porto 
Contact: 966557789 
 
Sub-Investigators 
 
Dr.ª Mariana de Magalhães Sant’Ana 
Rua de Vila Nova 10171, 4100 
4100-503 Porto 
Contact: 918448194 
 
Dr.ª Sofia Pinheiro Torres 
Rua de Vila Nova 10171, 4100 
4100-503 Porto 
Contacto: 226165380 
 
Investigation Center 
 
USF Aldoar 
Rua de Vila Nova 10171, 4100 
4100-503 Porto 
Contact: 226165380 
 

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1. Introduction 
Falls are a serious healthcare problem worldwide1,2 and the third biggest 
cause of chronic disability1. It is also estimated that falls are responsible for 
20 to 30% of all injuries and for 10 to 15% of all emergency department 
episodes3. 
 
In the elderly population, falls are a particularly serious problem. Annually, it 
is estimated that 28 to 35% of individuals aged 65 or over suffer a fall4,5, and 
this percentage goes up to 32 to 42% in individuals over 70. 
 
Besides age, there are several other risk factors for falls, which have been 
reviewed elsewhere6,7. The most important are: a) living alone; b) previous 
history of falls; c) presence of other chronic conditions (heart disease, chronic 
obstructive lung disease, ostheoarthritis); d) previous stroke; e) cognitive 
deficits; f) low vision; g) low body mass index; h) osteoporosis; i) multi-
medication (>4 concomitant drugs); j) psychotropic drugs (in particular 
benzodiazepines); k) diuretics and some antiarrithmic drugs; l) proprioceptive 
deficits. 
 
The consequences of falls in the elderly population are more severe than in 
other age groups. This results in a greater percentage of fatal falls8,9, but also 
in the percentage of hospital admissions related to falls, corresponding to 
7% of all admissions and to 85% of all accident-related admisisons in this 
population 10. Falls can also lead to insecurity 11, fear of falling 12 and loss of 
independence 13, worsening the problem even further. 
 

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With the aging world population, the number of falls is expected to increase1. 
Without preventive measures, this increase can reach 100% by 203014. Falls 
prevention can help the older population in maintaining its independence 
and quality of life, while reducing healthcare costs at the same time.15 
 
Physical exercise programs are one of the most effective tools in reducing the 
risk of falls in the elderly population, and their validity has been confirmed in 
several studies and meta-analysis15–18. To maximize their efficacy, these 
programs should be performed regularly, be progressive19, have multiple 
components (postural exercises, balance exercises and strength/endurance 
exercises)16,17 and be capable of promoting long-term engagement20. 
 
Despite good results demonstrated by these programs, the biggest 
challenge is to motivate older individuals to exercise and to maintain an 
active lifestyle 22. To maximize patient motivation, several authors stress the 
need for a tailored program prescribed by a healthcare professional23–25, 
additionally stating that the involvement of these professionals is one of the 
main motivating factors to this population 26 and that even general advice or 
brief telefone contacts can increase motivation 27. 
Besides the importance of involving healthcare professionals, physical activity 
programs for this population need to be entertaining and stimulating 24. This 
helps explain why digital systems have evolved so rapidly 28, with exergames 
attracting particular interest 29. Indeed, several studies demonstrate that 
exergames are a viable and safe solution 30,31 and that they are more 
engaging than comon exercise prescriptions 32,33. 
 

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Additionally, there is evidence showing an increase on clinical benefits and a 
stronger engagement with physical activity programs when older people use 
biofeedback-associated tracking and activity control devices 28,34,35. Moreover, 
given their potential benefits at such a low cost, biofeedback systems are 
becoming increasingly appealing 34. 
 
Over the last few years, SWORD Health has developed a novel biofeedback 
system - SWORD Phoenix ® - based on inertial motion trackers that digitize 
motion and use this information to provide real-time audiovisual feedback on 
performance. SWORD Phoenix ® takes advantage of biofeedback principles 
to increase the efficiency of exercise programs. Plus, it maximizes 
engagement through clean and user-friendly interfaces and gamification 
strategies. Furthermore, SWORD Phoenix® allows users to perform their 
rehabilitation sessions independently at home, under remote monitoring 
from the clinical teams. This way, SWORD Phoenix® smart and efficiently 
responds to the needs previously identified. 
 
Given the dimension of the problem of falls in the elderly population and the 
urgent need for a viable and cost-effective solution for falls prevention, 
SWORD Health has created an exercise program aimed at this problem, and 
integrated it within SWORD Phoenix®. 
 
2. Study Design 
This study is a single-center, prospective, non-blind, parallel-group, 
randomized controlled trial with an intervention and a control group. 

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3. Study Objective 
The aim of this study is to evaluate the clinical impact of a home-based falls 
prevention program using a new biofeedback system - SWORD Phoenix® - 
on community-dwelling older adults with fall risk in comparison with standard 
of care. 
The hypothesis is that the home-based falls prevention program using the 
SWORD Phoenix® system will lead to a lower risk of falling than standard 
medical care.  
 
4. Study Outcomes 
4.1 Primary outcome 
The primary outcome will be the change in fall risk between the baseline and 
the final assessment, measured through the “Five Times Sit to Stand Test”. 
 
4.2 Secondary outcomes 
The secondary outcomes will be: 
a) The change in fall risk between the baseline and the final assessment, 
measured by the “Berg Balance Test”.  
b) The change in fall risk between the baseline and the final assessment, 
measured by the “Timed Up and Go” test.  
c) The change in fear of falling, through the change on “Falls Efficacy 
Scale” score between the baseline and the final assessment. 
d) The percentage of participants with falls in the study population 
during the intervention period.  

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e) The percentage of participants with falls resulting in hospital 
admissions or emergency care visits, during the intervention period. 
 
5. Sample Size Estimation 
The sample size calculation was performed considering the variable chosen 
as the primary outcome - Five Times Sit to Stand Time (5XSST) - in a 
superiority scenario. 
To characterize the behavior of the primary outcome, a falls risk screening 
was performed in a representative sample of the population consisting of 40 
community-dwelling older individuals (>65 years old), followed at the 
Unidade de Saúde Familiar de Aldoar (USF Aldoar), who met the inclusion 
and exclusion criteria of this study. In this population, the mean score in the 
5XSST was 19.67 seconds, with a standard deviation of 4.25. 
Due to the lack of published data on the Minimal Clinically Important 
Difference (MCID) for the 5XSST, we considered the MDC95 (Minimal 
Detectable Change at the 95% confidence interval) reported by Goldberg et 
al. 36 in a population of community-dwelling elderly women. 
Considering a statistical power of 80%, a significance level of 0.05 (two-
tailed) and a dropout rate of 5%, 100 patients would be required to detect a 
difference of 2.5 points between the two groups (50 in each group). 
An interim statistical analysis on the results of the study will be performed 
upon reaching the 70% inclusion mark. If the superiority of the intervention 
group is demonstrated at this point, patient inclusion may be terminated. 
 

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6. Inclusion Criteria  
a) Patients aged over 65 years old  
b) Ability to walk at least 20 meters, unaided or with unilateral support  
c) Ability to understand motor complex commands  
d) Mini-Mental State Examination (MMSE) score > 24 points  
e) Functional independence for instrumental activities of daily living  
f) Risk of recurrent falls, defined as 5xSST score > 15,00 seconds  
 
7. Exclusion Criteria 
a) Patients residing in nursing homes, daycare units or assisted-living 
facilities  
b) Aphasia, dementia or psychiatric comorbidity, significantly interfering 
with communication or compliance with a home-based exercise 
program  
c) Severe visual our hearing, interfering with communication or with 
compliance to a home-based exercise program  
d) Cardiac, respiratory or other condition incompatible with at least 30 
minutes of light to moderate physical activity  
e) Osteoarticular conditions (e.g. severe osteoarthrosis), which prevent 
the patient from complying with a home-based exercise program  
f) Patients with neurologic conditions (e.g. stroke, multiple sclerosis, 
Parkinson’s disease)  
g) Other medical complications, which prevent the patient from 
complying with a home-based exercise program  
h) Illiteracy 
 

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8. Methods for identifying and recruiting patients  
In each research center, the candidates for the study will be identified 
through routine screening of patient lists from primary care consultations. 
Whenever a candidate is identified for the study, the participant will be 
approached by the investigator, who will explain the study in detail. The 
prospective candidate will be given the patient information document 
(Annex 1 – Information to Participants) and sufficient time to consider 
whether he wishes to participate in the study.  
Subsequently, the prospective candidate will be given the opportunity to 
clarify any doubts, after which the informed consent form (Annex 2- 
Informed Consent) will be signed and dated in duplicate by the patient and 
the investigator. Only then will the randomization and baseline assessments 
be performed. 
 
9. Patient allocation to study arms 
Patients will be randomized in a 1:1 ratio between arms, with randomization 
blocks of 4 patients. Randomization will be performed centrally by the 
principal 
investigator 
– 
FDC 
– 
through 
an 
online 
randomizer 
(www.randomizer.org) and communicated by telephone to the investigator 
responsible for data acquisition only after patient enrollment. 
 
10. Blinding 
The nature of the study does not allow blinding of the patients regarding 
study arms. However, participants will be blinded to the primary and 

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secondary outcomes being measured. In addition, patient assessment will be 
performed by one investigator blinded for data collection, for the 
intervention administration and for the study arm. Statistic analysis will be 
performed by a biostatistician blinded for the study arm.  
 
11. Patient assessment  
Patients will be assessed before the beginning of the intervention (AO), and 
then every four weeks - week 4 (A4), 8 (A8) and 12 (A12). A follow-up 
assessment will also be performed 12 weeks after the end of the intervention 
(A24). 
The assessments will be performed in a window of five working days before 
or after the day on which the assessement should take place.  
 
11.1 Baseline Assessment (AO) 
In this assessment will be collected the following information:  
a) Gender 
b) Date of Birth 
c) Educational Level (years) 
d) Known fall risk factors  
a. History of falls in the last year  
b. Living alone  
c. Chronic disease  
i. DM 
ii. Cardiac disease 
iii. Respiratory disease (CPD/COPD) 
iv. Osteoarticular disease (osteoarthrosis and osteoporosis) 

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d. Concomitant Medication  
i. Number of medications  
ii. Use of benzodiazepines or other sedative medication  
iii. Use of antiarrhytmics  
iv. Use of diuretics  
e. Body mass index 
f. Visual acuity loss  
 
A multi-dimentional characterization of the participants’ functional status will 
also be performed, through specific performance tests (Five Times Sit to 
Stand Test and Timed up and Go Test), a balance test (Berg Balance Scale) 
and a self-reported fear of falling scale (Short Falls Efficacy Scale-
International) - see Annex 3: assessment scales and application 
instructions. 
 
The 5XSST 37 is a performance test that measures the strength and the lower 
limb mobility, which has been validated by Buatois et al. as a reliable marker 
of falls risk in elderly community-dweller population 
38. The same 
investigators reported a cutoff value of 15 seconds to distinguish between 
individuals with and without risk of recurrent falls 39. Although the Minimal 
Clinically Important Change has not been published for this test, Goldberg et 
al reported an MDC95 (Minimal Detectable Change at the 95% confidence 
interval) of 2.5 seconds in a elderly community-dweller women population 36. 
This test was chosen as the primary outcome for its proven validity, simplicity 
of application, existence of a well-defined cutoff value and a well-defined 
MCD95. 
 

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The TUG is a performance test that assesses the mobility, balance and gait in 
elderly individuals and was developed in 1991 based on “Get up and Go 
Test” 40. A shorter time indicates better performance, usually using the cutoff 
level of 13.5 seconds to identify individuals at risk of falling in the community 
45. However, the cutoff value reported in the literature varies between 10 and 
33 seconds 46,47. The TUG is a fall risk assessment tool recommended by 
several international guidelines 48. However, a recent systematic review has 
shown that this test has limited utility in the prediction of falls in the elderly 
population inserted in the community, and should not be used alone for this 
purpose 41. 
 
The Berg Balance Scale (BBS) 42 was developed to evaluate the static and 
dynamic balance in three domains: sitting, standing and changing posture. It 
is a scale composed of 14 items graded by an external observer on 5 levels 
(from 0 to 4). Scale scores range from 0 to 56, with higher scores 
representing a higher level of functionality. The validity of this scale in the 
prediction of fall risk was confirmed by several studies, including a recent 
meta-analysis 43. However, there is no consensus regarding the cutoff level 
used in the published studies (from 29 to 52 points), and this meta-analysis 
suggested a cutoff level between 45 and 49 points to distinguish individuals 
at low risk from the rest 51. In the absence of consensus on cutoff level, we 
chose not to use this scale as the primary outcome of the study. 
 
The Falls Efficacy Scale- International (FES-I) 44 was developed in order to 
systematize on a scale the fear of falling. It is a questionnaire of 16 items 
filled by the user, evaluating from 1 to 4 the fear of falling during the 

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execution of a series of activities of daily living. It is a standardized and 
comparable measure over time, which provides an additional dimension in 
the characterization of participants. To maximize its practical applicability, a 
shortened version of the Short Falls Efficacy Scale- International: Short 
FES-I was developed and validated with 7 items (instead of 16) 53. Delbaere 
et al. 45 subsequently validated the cutoff levels for Short FES-I: low fear (7-8); 
moderate fear (9-13) and high fear (14-28). A recent study also showed that 
this scale has a good correlation with objective fall risk measures such as TUG 
55. 
11.2 Interim assessments (A4 and A8), final assessment (A12) and follow-
up assessment (A24)  
These assessments will be performed by an investigator blinded to the 
randomization arm and will consist of: 
a) TUG 
b) 5XSST 
c) BBS 
d) FES 
 
12. Intervention 
 
Participants in the control group will benefit from standard medical care 
currently in place at the participating primary care facility. 
 
Participants within the experimental group will perform a 12-week falls 
prevention program through SWORD Phoenix®, under remote monitoring 
from a physical therapist. Participants will be asked to perform sessions at 

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least 3 days per week. In case of non-compliance with this periodicity, 
patients will not be excluded from the study, but will not be considered in 
"per 
protocol” 
analysis. 
Notwithstanding, 
daily 
sessions 
will 
be 
recommended (although not mandatory). 
 
The program will consist of the following exercises: 
Exercise 
Sets 
Repetitions 
Notes 
Strengthening exercises 
Sitting exercises 
Sitting knee extension 
1 
20 
Increase difficulty using ankle 
weights 
Sit to Stand 
1 
12 
 
Standing exercises 
Standing hip abduction 
1 
20 reps 
 
Standing knee flexion 
1 
20 reps 
 
Squats 
1 
12 reps 
 
Forward 
lunge 
with 
hold 
1 
10 reps 
 
Balance exercises 
Single-leg stance 
1 
10 reps 
Patient will earn 1 star for 
each 5 seconds, up to 25 
seconds 
Single-leg stance with 
hip abduction 
1 
10 reps 
Walking exercises 
March on the same 
spot 
1 
40 steps 
 
Multi-directional steps 
1 
20 steps 
 
Square walking 
1 
5 reps 
 
 
The exact composition of each program will be tailored according to the 
particpant’s specific needs, as defined by the physical therapist, i.e., it is not 
mandatory that every participant performs all exercises listed above. 
 
The difficulty of each exercise (number of repetitions, series, weight addition 
or withdrawal of support) will be adjusted by the physical therapist, according 
the participant’s stage and evolution. 

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Face-to-face visits 
Each study participant allocated to the experimental group will receive an 
initial visit from the physiotherapist, which will be responsible for his 
monitorization during the program. In this visit, an initial assessment of the 
user’s needs will be perfromed to define a tailored program. Training on the 
system’s usage will be given, and the first session will be carried out in the 
presence of the therapist, to ensure that the user can interact autonomously 
with the system (or leastwise caregiver-aided).  
 
From this visit onwards, the participant will be monitored remotely by the 
physical therapist, without subsequent face-to-face sessions. In the 4th and 
8th weeks, each participant will receive a visit from the physical therapist for 
reassessment and adjustment of the program. There will be no face-to-face 
sessions during these two visits. 
 
A follow-up telephone call will take place every two weeks (weeks 2, 6, 10). 
 
Finally, extra visits or telephone calls can also me made, if necessary, and 
these will be registered on patient’s file (date, reason, duration). 
Table 2 summarizes the interventional steps of the program: 
 
 
 

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Table 2. Schedule of face-to-face visits and telephone calls 
 
Week 
Face-to-face visits 
Telephone calls 
0 
X 
 
2 
 
X 
4 
X 
 
6 
 
X 
8 
X 
 
10 
 
X 
12 
X 
 
 
 
13. Safety and adverse events  
Patient safety will be ensured during all the process. For patients in the 
experimental group, safety 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 the physical therapist. In case of excessive pain or 
fatigue, patients will be contacted to ascertain the cause and readapt 
prescription. Patients will also be instructed to report any other adverse 
events to their physical therapist by phone.  
 
In the control group, in addition to the interim assessments, patients will be 
instructed to report any adverse events to a study investigator and, for this 
purpose, a direct phone contact will be provided. 
 

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All adverse events will be recorded on the participant's file (start date, 
resolution date - if applicable), resolution status and severity). 
 
14. Statistic analysis  
To assess differences in clinical and demographic variables of the patients 
allocated to the two study groups, independent samples test or Mann–
Whitney U test will be used for quantitative variables. For qualitative 
variables, Chi-squared test Fisher’s exact test will be used.  
Outcome analysis will be performed using a “per-protocol” analysis. Patients 
with adherence less than 43% (corresponding to at least 3 weekly sessions) 
will not be considered on the “per protocol” analysis. 
The impact of the interventions in the primary and secondary outcomes will 
be evaluated considering the change between baseline and week 12. 
Differences between the two study groups will be assessed using 
independent samples test or Mann-Whitney U test.   
Since outcomes will be measured in several different times during the 
program, a repeated measures analysis will also be performed, using a 
3x2/4x2 ANOVA, with group as an independent factor and time as a within-
subjects factor.  
 
15. Potential risks and benefits to participants 
There are no invasive procedures involved in this protocol and no relevant 
risks are foreseen in both groups. 
Participants in the control group will continue to benefit from the standard 

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medical care currently in place at the participating center, and thus no 
increased associatred risk is expected in this study. Conversely, direct clinical 
benefit from the study is not expected as well. However, participants will be 
contributing to the development and testing of an innovative tool that could 
have a significant positive impact on the older population’s quality of life. 
Participants in the experimental group will perform a falls prevention 
program through SWORD Phoenix®, under remote monitoring of a physical 
therapist. The therapist 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 
addition, no adverse events resulting from the use of SWORD Phoenix® have 
been reported so far. Thus, participants in the intervention group are not at 
increased risk and may directly benefit from the intervention, by improving 
their muscular strength and balance and, consequently, by reducing falls risk. 
 
16. Data protection  
Data collection for this study was authorized by the National Commission on 
Data Protection, with the authorization number 5457/2018. 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 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. 
 

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17. Ethical issues 
All participants will be provided with information about the purpose and 
procedures of the study and must give written informed consent before 
inclusion. 
The study was approved by the relevant Ethics Committee - Comissão de 
Ética da ARS Norte (Chair: Prof Doutor Pedro Hespanhol) and will be 
conducted in accordance with the relevant guidelines and regulations.  
 
18. Dissemination of results 
The results of the study will be published in peer-reviewed scientific journals 
and presented at relevant national and international meetings.  
 
19. System Technical Specifications 
SWORD Phoenix® is a CE- and FDA- certified class I medical device 
composed of the following components: 
 
Inertial motion trackers 
These are small high-precision motion trackers that capture and digitize the 
user´s motion, which is then transmitted via Bluetooth to the Phoenix App. 
The motion trackers are fixed to Velcro straps placed in specific body 
positions. 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 

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- 
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 
 
Phoenix App 
The 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, featuring a simple 
and intuitive interface indicating the movement to be performed, a repetition 
counter and a star counter. Patients earn stars for every correct repetition, 
which is defined as a movement starting at the baseline and reaching or 
surpassing a movement threshold, 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. 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 rewarding badges for his 
main achievments. 
  
Phoenix 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, 

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the clinical team can edit the parameters of each exercise according to 
patient performance and progress. 
 
 
References 
 
1. 
World Health Organization. WHO Global Report on Falls Prevention in Older Age. 
Community Health (2007). doi:978 92 4 156353 6 
2. 
Day, L. et al. A protocol for evidence-based targeting and evaluation of statewide 
strategies for preventing falls among community-dwelling older people in Victoria, 
Australia. Inj. Prev. 17, 1–8 (2011). 
3. 
Scuffham, P., Chaplin, S. & Legood, R. Incidence and costs of unintentional falls in 
older people in the United Kingdom. J. Epidemiol. Community Heal. 57, 740–744 
(2003). 
4. 
Prudham, D. & Evans, J. G. Factors associated with falls in the elderly: A community 
study. Age Ageing 10, 141–146 (1981). 
5. 
Campbell, A. J., Reinken, J., Allan, B. C. & Martinez, G. S. Falls in old age: A study of 
frequency and related clinical factors. Age Ageing 10, 264–270 (1981). 
6. 
NARI (National Ageing and Research Institute). ‘An analysis of research on preventing 
falls and falls injury in older people: Community, residential care and hospital 
settings’ (2004 update). Aust. Gov. Dep. Heal. Ageing, Dep. Heal. Ageing, Inj. Prev. 
Sect. (2004). 
7. 
Todd, C. & Skelton, D. What are the main risk factors for falls amongst older people 
and what are the most effective interventions to prevent these falls ? World Health 28 
(2004). 
8. 
Nevitt, M. C., Cummings, S. R., Kidd, S. & Black, D. Risk Factors for Recurrent 
Nonsyncopal Falls: A Prospective Study. JAMA J. Am. Med. Assoc. 261, 2663–2668 
(1989). 
9. 
Phelan, E. A., Mahoney, J. E., Voit, J. C. & Stevens, J. A. Assessment and 
Management of Fall Risk in Primary Care Settings. Medical Clinics of North America 
99, 281–293 (2015). 
10. 
Scott V, Pearce M, P. C. Seniors’ falls in Canada. (Division of Aging and Seniors; 
Public Health Agency of Canada, 2005). 
11. 
Tinetti, M. E. & Williams, C. S. Falls, injuries due to falls, and the risk of admission to a 
nursing home. N. Engl. J. Med. 337, 1279–84 (1997). 
12. 
Tinetti, M. E. & Williams, C. S. The Effect of Falls and Fall Injuries on Functioning in 
Community-Dwelling Older Persons. Journals Gerontol. Ser. A Biol. Sci. Med. Sci. 
53A, M112–M119 (1998). 
13. 
Vellas, B., Cayla, F., Bocquet, H., de Pemille, F. & Albarede, J. L. Prospective study of 
restriction of activity in old people after falls. Age Ageing 16, 189–193 (1987). 
14. 
Kannus, P., Palvanen, M., Niemi, S. & Parkkari, J. Alarming rise in the number and 
incidence of fall-induced cervical spine injuries among older adults. J. Gerontol. A. 
Biol. Sci. Med. Sci. 62, 180–3 (2007). 

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Date: 11/14/2018 
15. 
Salkeld, G. et al. Quality of life related to fear of falling and hip fracture in older 
women: a time trade off study. BMJ 320, 341–6 (2000). 
16. 
Gillespie, L. D. et al. Interventions for preventing falls in older people living in the 
community. Cochrane database Syst. Rev. 9, CD007146 (2012). 
17. 
El-Khoury, F., Cassou, B., Charles, M.-A. & Dargent-Molina, P. The effect of fall 
prevention exercise programmes on fall induced injuries in community dwelling older 
adults: systematic review and meta-analysis of randomised controlled trials. BMJ 347, 
f6234 (2013). 
18. 
Cameron, I. D. et al. Interventions for preventing falls in older people in nursing care 
facilities and hospitals. Cochrane Database Syst. Rev. CD005465 (2010). 
doi:10.1002/14651858.CD005465.pub2 
19. 
Sherrington, C. et al. Effective exercise for the prevention of falls: A systematic review 
and meta-analysis. J. Am. Geriatr. Soc. 56, 2234–2243 (2008). 
20. 
Delbaere, K. et al. Evaluating the effectiveness of a home-based exercise programme 
delivered through a tablet computer for preventing falls in older community-dwelling 
people over 2 years: Study protocol for the Standing Tall randomised controlled trial. 
BMJ Open 5, (2015). 
21. 
Robertson, M. C., Campbell, A. J., Gardner, M. M. & Devlin, N. Preventing injuries in 
older people by preventing falls: A meta-analysis of individual-level data. J. Am. 
Geriatr. Soc. 50, 905–911 (2002). 
22. 
Pyae, A. et al. Investigating the Finnish elderly people ’ s attitudes and motivation 
towards digital game - based physical exercises. Finnish J. eHealth eWelfare 9, 
(2017). 
23. 
Nelson, M. E. et al. Physical activity and public health in older adults: 
Recommendation from the American College of Sports Medicine and the American 
Heart Association. Medicine and Science in Sports and Exercise 39, 1435–1445 
(2007). 
24. 
Devereux-Fitzgerald, A., Powell, R., Dewhurst, A. & French, D. P. The acceptability of 
physical activity interventions to older adults: A systematic review and meta-synthesis. 
Soc. Sci. Med. 158, 14–23 (2016). 
25. 
Franco, M. R. et al. Older people’s perspectives on participation in physical activity: A 
systematic review and thematic synthesis of qualitative literature. British Journal of 
Sports Medicine 49, 1268–1276 (2015). 
26. 
Schutzer, K. A. & Graves, B. S. Barriers and motivations to exercise in older adults. 
Preventive Medicine 39, 1056–1061 (2004). 
27. 
Bennett, J. A. & Winters-Stone, K. Motivating older adults to exercise: What works? 
Age and Ageing 40, 148–149 (2011). 
28. 
Vaziri, D. D. et al. Exploring user experience and technology acceptance for a fall 
prevention system: results from a randomized clinical trial and a living lab. Eur. Rev. 
Aging Phys. Act. 13, 1–9 (2016). 
29. 
Hasselmann, V., Oesch, P., Fernandez-Luque, L. & Bachmann, S. Are exergames 
promoting mobility an attractive alternative to conventional self-regulated exercises 
for elderly people in a rehabilitation setting? Study protocol of a randomized 
controlled trial. BMC Geriatr. 15, 1–9 (2015). 
30. 
Skjæret, N. et al. Exercise and rehabilitation delivered through exergames in older 
adults: An integrative review of technologies, safety and efficacy. Int. J. Med. Inform. 
85, 1–16 (2016). 
31. 
Karahan, A. Y. et al. Effects of exergames on balance, functional mobility, and quality 
of life of geriatrics versus home exercise programme: Randomized controlled study. 

RCT-FP-01 Study Protocol 
 
 
 
Version 1.3 
Date: 11/14/2018 
Cent. Eur. J. Public Health 23, S14–S18 (2015). 
32. 
Karahan, A. Y. et al. Effects of exergames on balance, functional mobility, and quality 
of life of geriatrics versus home exercise programme: Randomized controlled study. 
Cent. Eur. J. Public Health 23, S14–S18 (2015). 
33. 
Meekes, W. & Stanmore, E. K. Motivational determinants of exergame participation 
for older people in assisted living facilities: Mixed-methods study. J. Med. Internet 
Res. 19, (2017). 
34. 
Alhasan, H., Hood, V. & Mainwaring, F. The effect of visual biofeedback on balance in 
elderly population: A systematic review. Clin. Interv. Aging 12, 487–497 (2017). 
35. 
Zijlstra, A., Mancini, M., Chiari, L. & Zijlstra, W. Biofeedback for training balance and 
mobility tasks in older populations: A systematic review. J. Neuroeng. Rehabil. 7, 58 
(2010). 
36. 
Goldberg, A., Chavis, M., Watkins, J. & Wilson, T. The five-times-sit-to-stand test: 
Validity, reliability and detectable change in older females. Aging - Clin. Exp. Res. 24, 
339–344 (2012). 
37. 
Bohannon, R. W. Reference Values for the Five-Repetition Sit-to-Stand Test: A 
Descriptive Meta-Analysis of Data from Elders. Percept. Mot. Skills 103, 215–222 
(2006). 
38. 
Buatois, S. et al. Five times sit to stand test is a predictor of recurrent falls in healthy 
community-living subjects aged 65 and older. J. Am. Geriatr. Soc. 56, 1575–1577 
(2008). 
39. 
Buatois, S. et al. A Simple Clinical Scale to Stratify Risk of Recurrent Falls in 
Community-Dwelling Adults Aged 65 Years and Older. Phys. Ther. 90, 550–560 
(2010). 
40. 
Podsiadlo, D. & Richardson, S. The timed ‘Up & Go’: a test of basic functional 
mobility for frail elderly persons. J. Am. Geriatr. Soc. 39, 142–148 (1991). 
41. 
Barry, E., Galvin, R., Keogh, C., Horgan, F. & Fahey, T. Is the Timed Up and Go test a 
useful predictor of risk of falls in community dwelling older adults: A systematic 
review and meta- analysis. BMC Geriatr. 14, (2014). 
42. 
Berg, K. O., Wood-Dauphinee, S. L., Williams, J. I. & Maki, B. Measuring balance in 
the elderly: Validation of an instrument. in Canadian Journal of Public Health 83, 
(1992). 
43. 
Park, S. H. & Lee, Y. S. The Diagnostic Accuracy of the Berg Balance Scale in 
Predicting Falls. Western Journal of Nursing Research 39, 1502–1525 (2017). 
44. 
Yardley, L. et al. Development and initial validation of the Falls Efficacy Scale-
International (FES-I). Age Ageing 34, 614–619 (2005). 
45. 
Delbaere, K. et al. The falls efficacy scale international (FES-I). A comprehensive 
longitudinal validation study. Age Ageing 39, 210–216 (2010). 
56.  
Spencer MP, and Folstein MF. The Mini-Mental State Examination. In: PA Keller and 
LG Ritt (Eds). Innovations in Clinical Practice: A Source Book. Vol 4. Sarasota, FL: 
Professional Resource Exchange, Inc.,307-308, 1985. 
 
 

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ANNEX 1 
 
INFORMATION TO PARTICIPANTS 
 
 
 

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CLINICAL IMPACT OF A DIGITAL HOME-BASED FALLS 
PREVENTION PROGRAM ON ELDERLY PEOPLE  
– A RANDOMIZED CONTROLLED TRIAL 
 
 
 
PARTICIPANT INFORMATION 
 
 

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This leaflet is intended to inform you of a clinical trial that USF Aldoar 
and SWORD Health are currently undertaking. 
 
What is the purpose of the study?  
This study aims to assess the clinical impact of a home-based falls prevention 
program using a new technology named SWORD Phoenix® in people over 
65 years in risk of falling, compared to standard medical care. 
 
What is SWORD Phoenix?  
SWORD Phoenix® is a system composed of motion trackers placed on the 
trunk and on lower limbs through Velcro straps. These trackers digitize your 
movements and send this information to a mobile App (on a tablet). This App 
guides you through the exercise sessions and tells you whether you are 
performing them properly or not, helping you to correct any errors. 
The information is then uploaded to an internet platform, where the clinical 
team can remotely analyze the sessions, introducing changes as needed. 
Thus, you will have a clinical team monitoring you remotely. 
 
Is this study for me?  
This study is intended for people over the age of 65, living in the community, 

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and who are at risk of falling. This leaflet was delivered to you because you 
are a potential candidate to participate in the study. 
 
What happens next?  
If you agree to participate, and you meet the study criteria after an initial 
assessment, you will be assigned to one of two groups: an experimental 
group or a control group. 
 
Participants in the experimental group will perform a falls prevention 
program through the SWORD Phoenix® system, under the remote 
supervision of a physical therapist. This program will last 12 weeks, during 
which you must perform at least 3 exercise sessions per week. Throughout 
the program, the sessions will be adapted by the physiotherapist according 
to the performance. 
 
Participants in the control group will continue to benefit from health care 
routinely provided at the USF Aldoar, which includes fall risk assessment, 
optimization of medication and information on how to prevent falls. 
Participants in this group will not do any specific fall prevention program. 
 

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What are the risks associated with participating in the study? 
There are no risks associated with participation in any of the groups, as no 
risks arising from the use of the SWORD Phoenix® system are known. 
 
Am I required to participate? And what are the costs?  
No. Participation in this study is entirely voluntary and does not entail any 
financial burden.  
 
What happens if I do not want to participate?  
If you do not want to participate, this will not have any negative 
consequences to you. In this case, you will continue having your usual follow-
up with your Primary Care Physician. 
 
Who will have access to my data?  
Identification data will only be known to the trial investigators and will not be 
made public under any circumstances. 
All data collected will solely and exclusively be used for the production of 
scientific articles that will always be anonymous, guaranteeing privacy and 
the protection of participants’s personal data. 
 

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If you have further questions about the study, please contact your Physician 
or the Study Investigators through the following contacts: 
Dr Mariana Sant’Ana: 
Dr Fernando Correia: 966557789 
 
 

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ANNEX 2 
 
INFORMED CONSENT 
 
 

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CLINICAL IMPACT OF A DIGITAL HOME-BASED FALLS 
PREVENTION PROGRAM ON ELDERLY PEOPLE  
– A RANDOMIZED CONTROLLED TRIAL 
 
 
 
 
 
 
 
INFORMED CONSENT 
 
 

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Clinical impact of a digital home-based falls prevention 
program on elderly people – a randomized controlled trial 
 
Informed Consent 
 
I declare that I have received verbal and written information about the study 
in which I was invited to participate. 
 
I read and understood all the information that was transmitted to me and had 
the opportunity to put the doubts that I thought necessary, which have been 
clarified to me. 
 
I also understand my right to withdraw this study at any time, without having 
to give any explanation and without suffering any reprisals. 
 
I understand that the results of the study can be published in Scientific 
Journals and used in other investigations, without any breach of 
confidentiality. I hereby authorize the use of the data for these purposes. 
 
For these reasons, I agree to participate voluntarily in this study. 
 
Name of participant: __________________________________________________ 
Signature of participant: _______________________________________________ 
 
Date: __ /__ /____ 
 
Name of investigator: _________________________________________________ 
Signature of investigator: ______________________________________________ 
 
Date: __ /__ /____ 

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ANNEX 3 
 
ASSESSMENT SCALES AND APPLICATION INSTRUCTIONS 
 
 
 

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MMSE (Mini-Mental State Examination) 
 
The MMSE measures cognitive ability and begins with the assessment of 
spatial and temporal orientation, with a maximum of 10 points. Then, two 
aspects of memory are tested. 
The first consists of the immediate memory of three orally presented objects, 
followed by a serie of seven intercalated tasks that evaluate attention, 
concentration and calculation, preventing the user from memorizing the 
three previously learned objects. In this section a maximum of 11 points can 
be obtained. 
The last section assesses aphasia, testing naming, repetition, perceiving a 
three-step command, reading, writing, and copying a drawing. A maximum 
of 9 points can be obtained for a maximum total of 30 points. 
 
I. ORIENTATION 
 
1) Ask for: the year, season, date, day, month. Then ask specifically for 
parts omitted e.g. “Can you also tell me what season it is?”. One point for 
each correct. 
2) Ask in turn, “Can you tell me the name of this department? (state, 
country, town, hospital, floor.) 
 
 
II. REGISTRATION 
Ask the patient if you may test his memory. Then say the names of 3 
unrelated objects, clearly and slowly, about one second for each. After you 
have said all 3, ask him to repeat them. This first repetition determines his 
score (0-3) but keep saying them until he can repeat all 3, up to 6 trials. If he 
does not eventually learn all 3, recall cannot be meaningfully tested. 

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III. ATTENTION AND CALCULATION  
Ask the patient to begin with 100 and count backward by 7. Stop after 5 
subtractions (93, 86, 79, 72, 65). Score the total number of correct answers. If 
the patient cannot or will not perform his task, ask him to spell the word 
"world" backward. The score is the number of letters in correct order, e.g., 
dlrow=5, dlorw=3. 
 
IV. RECALL 
Ask the patient if he can recall the 3 words you previously asked him to 
remember in the registration section. Score 0-3. 
 
V. LANGUAGE  
NAMING: Show the patient a wrist watch and ask him what it is. Repeat for 
pencil. Score 0-2. 
 
REPETITION: Ask the patient to repeat the sentence "No ifs, ands, or buts" 
after you. Allow only one trial. Score 0-1. 
 
3 STAGE COMMAND: Give the patient a piece of plain blank paper and ask 
him to follow your instructions: "Take the paper in your right hand, fold it in 
half and put it on the floor." Score 1 point for each part correctly performed. 
 
READING: On a blank piece of paper, print the sentence, "Close your eyes," 
in letters large enough for the patient to see clearly. Ask him to read it and 
do what it says. Score 1 point only if he actually closes his eyes. 
 

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WRITING: Give the patient a blank piece of paper and ask him to write a 
sentence for you. Do not dictate a sentence. It is to be written 
spontaneously. It must contain a subject and a verb and be sensible. Correct 
grammar and punctuation are not necessary. 
 
COPYING: On a clean piece of paper, draw two intersecting pentagons, 
each side about 1 inch, and ask him to copy it exactly as it is. All 10 angles 
must be present and 2 must intersect to score 1 point. Tremor and rotation 
are ignored. 
 
 
 

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Timed up and Go Test 
The Timed Up and Go is a test that assesses mobility, balance, walking 
ability in older adults. 
To perform the test, follow the instructions: 
1) Select a chair with armrests and a seating height of 44-47 cm 
2) Measure 3 meters in a straight line from the chai rand 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 chai rand 
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 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Five Times Sit to Stand Test 
The Five Times Sit to Stand Test is a functional measure of lower limb 
muscle strength that quantifies the functional change of transitional 
movements. 
To perform the test, follow the instructions: 
1) Select a chair with armrests and ask the patient to sit in the middle 
of the seat with arms crossed behind the neck or arms crossed with 
hands touching the shoulders. Advise the patient to keep their feet 
on the ground and correct posture 
2) Instruct the patient to rise from the chair and sit five times as fast as 
possible on the command “start” 
3) Ask the patient to stand up completely between the test repetitions 
and not touch the back of the chair during each repetition 
4) The counting begins on the command “start” and ends when the 
hips are in contact with the chair after the fifth repetition.  
5) Register the time with two decimal digits in the patient file 
(maximum 2 minutes) 
6) Failure to complete the five repetitions without assistance or 
support from the upper limb indicates non-compliance with the 
test. 
 
 

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Berg Balance Scale 
 

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Short Falls Efficacy Scale - International 
 
Kempen GIJM, Yardley L., Haastregt JCM van, Zijlstra GAR, Beyer N, Hauer K, Todd C. 
Short FES-I  
Now we would like to ask some questions about how concerned you are about the 
possibility of falling. Please reply thinking about how you usually do the activity. If you 
currently don’t do the activity, please answer to show whether you think you would be 
concerned about falling IF you did the activity. For each of the following activities, 
please tick the box which is closest to your own opinion to show how concerned you are 
that you might fall if you did this activity. 
 
 
Not at all 
concerned
1 
Somewhat 
concerned 
2 
Fairly 
concerned 
3 
Very 
concerned
4 
1 
Getting dressed or undressed 
 
 
1   
2   
3   
4   
2 
 
Taking a bath or shower 
 
 
1   
2   
3   
4   
3 
 
Getting in or out of a chair 
 
 
1   
2   
3   
4   
4 
 
Going up or down stairs 
 
 
1   
2   
3   
4   
5 
 
Reaching for something above 
your head or on the ground 
 
1   
2   
3   
4   
6 
Walking up or down a slope 
 
 
1   
2   
3   
4   
7 
 
Going out to a social event 
(e.g. religious service, family 
gathering or club meeting) 
1   
2   
3   
4  