Evaluation of the Impact of Non-slip Socks on Motor Recovery in the Elderly An Open Label, Single-center, Randomized, Controlled Pilot Study
Phase: NA
Conditions: Aging, Acute Care Unit, Fall Injury
Sponsor: Centre Hospitalier Departemental Vendee

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ChARM protocol 
 
 
 
Registration: n° 2021-A00349-32 
Ref : CHD 20-0059 
 
 
"Evaluation of the impact of Slip Resistant Socks on Motor 
Recovery in the Elderly.   
An Open-Label, Single-Center, Randomized, Controlled 
Pilot Study". 
 
 
Coordinating Investigator :  
Thomas Rulleau,  
Research engineer - physiotherapist 
Vendee Departmental Hospital 
Geriatric Short Stay Department and Clinical Research Unit 
thomas.rulleau@chd-vendee.fr 
 
 
 
Methodologist :  
  
Lucie PLANCHE 
Vendee Departmental Hospital 
Clinical Research Unit 
lucie.planche@chd-vendee.fr 
 
 
Sponsor :  
   Center Hospitalier Départemental Vendée 
Clinical Research Unit 
Boulevard Stéphane MOREAU 
85 925 LA ROCHE SUR YON Cedex 09 
Tel: 02 51 44 65 72 
Fax: 02 51 44 65 85 
 
 
 

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LIST OF ABBREVIATIONS 
 
 
 
 
ANSM 
Agence Nationale de Sécurité du Médicament et des Produits de 
Santé (French Agency for the Safety of Medicines and Health 
Products) 
ARC 
Clinical Research Associate (monitor) 
BPC 
Good Clinical Practice 
PPC 
Comité de Protection des Personnes  
CNIL 
Commission Nationale de l'Informatique et des Libertés (French 
Data Protection Authority) 
CRF 
Case Report Form (observation booklet) 
eCRF 
Electronic Case Report Form (cahier d'observation électronique) 
MR 
CNIL Reference Methodology 
TEC 
Clinical Study Technician 
 
 
 
 
 

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TABLE OF CONTENTS 
 
LIST OF ABBREVIATIONS .................................................................................................. 3 
TABLE OF CONTENTS ........................................................................................................ 4 
INTRODUCTION ................................................................................................................... 5 
1. 
RATIONALE FOR THE STUDY ..................................................................................... 6 
1.1. 
Research positioning ............................................................................................... 6 
1.2. 
Benefits and risks for research subjects .................................................................. 8 
2. 
OBJECTIVES AND JUDGING CRITERIA ....................................................................10 
2.1. 
Objective and primary endpoint ..............................................................................10 
2.2. 
Objectives and secondary evaluation criteria..........................................................10 
3. 
STUDY POPULATION ..................................................................................................11 
3.1. 
Description of the population ..................................................................................11 
3.2. 
Inclusion criteria .....................................................................................................11 
3.3. 
Non-inclusion criteria ..............................................................................................11 
4. 
DESIGN AND STUDY PROCESS.................................................................................12 
4.1. 
Study schedule .......................................................................................................12 
4.2. 
General research methodology ..............................................................................15 
4.3. 
Study diagram ........................................................................................................16 
4.4. 
Description and justification of the therapeutic regimen/method studied .................17 
4.5. 
Description of the evaluation and data collected .....................................................17 
4.6. 
Identification of all source data not included in the medical record .........................19 
4.7. 
Rules for terminating a person's participation .........................................................19 
4.8. 
COMPENSATION ..................................................................................................20 
5. 
SAFETY ASSESSMENT ...............................................................................................21 
6. 
DATA MANAGEMENT AND STATISTICS ...................................................................22 
6.1. 
Study data collection and processing .....................................................................22 
6.2. 
Statistics .................................................................................................................23 
7. 
ADMINISTRATIVE AND REGULATORY ASPECTS ....................................................26 
7.1. 
Right of access to source data and documents ......................................................26 
7.2. 
Data confidentiality .................................................................................................26 
7.3. 
Study monitoring ....................................................................................................26 
7.4. 
Inspection / Audit ....................................................................................................27 
7.5. 
delegation of tasks .................................................................................................27 
7.6. 
declaration to the competent authorities .................................................................27 
7.7. 
Protocol amendments ............................................................................................27 
7.8. 
Computerized data and submission to the CNIL .....................................................28 
7.9. 
Patient information .................................................................................................28 
7.10. 
Financing and insurance .....................................................................................28 
7.11. 
Publication rules .................................................................................................29 
7.12. 
Archiving source data .........................................................................................29 
8. 
REFERENCES ..............................................................................................................30 

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INTRODUCTION 
 
With advancing age, many patients lose their autonomy. This loss of autonomy can be 
increased during hospitalization, by the effect of the pathology itself, or by the effect of 
hospitalization. The aim of the rehabilitation team is to put in place tools to preserve patients' 
motor skills, through rehabilitation sessions and/or the use of appropriate equipment. In 
particular, they ensure that walking aids and footwear are adapted to the patient's clinical 
condition. 
 
However, senior patients arriving on the medical ward do not always have adequate 
footwear. The teams in charge of these patients, including physiotherapists, are faced with 
the choice of either keeping the original footwear, or offering patients the option of walking 
barefoot. The choice of keeping the usual footwear is the most frequent.  
For some time now, it has been possible to offer non-slip socks for walking around their 
wards. However, there is controversy in the scientific literature about the usefulness of these 
devices. In particular, it is impossible to transpose the results of studies to assess the 
benefits of these socks for senior citizens. 
 
The aim of this study was to assess the effect of non-slip socks on motor recovery. 

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1. JUSTIFICATION FOR THE STUDY 
1.1. 
Research positioning 
1.1.1. 
Rational 
In 2012, people aged 65 or over represented 17.1% of the population (16% in 2002), half of 
whom were aged 75 or over. This represents an increase of 45% in 20 years (INSEE, 2012). 
In 2015, 2.5 million seniors in France were losing their autonomy (INSEE, 2017). Among 
seniors aged 75 and over, 8.8% live in institutions (INSEE, 2017). The projection for 2050 is 
that 4 million seniors will lose their autonomy, i.e. 16.4% of all seniors (INSEE, 2017).  
 
Frequently, the aging of sick or frail people undergoes physical deconditioning as a result of 
pathologies leading to hospitalization. Deconditioning is a psychophysiological process 
leading to physical inactivity. It is defined as "an amplifier of vulnerability, leading to situations 
of dependence and an altered quality of life". (Préfaut & Ninot, 2009) . Muscle mass, strength 
and power decline with age, and by the age of 80, older people have lost half their initial 
muscle mass (Professional Associations for Physical Activity, Sweden, 2010) 
 
 
Figure 1: The vicious circle of deconditioning from Hadjistavropoulos et al (2011) 
According to Hadjistavropoulos et al. (2011)a vicious circle of deconditioning exists in senior 
citizens. A fall leads to a fear of falling, which leads to activity restriction, which leads to 

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functional decline, which leads to reduced stability, which leads to an increased risk of falling 
(Error! Reference source not found.). 
 
On arrival on short-stay wards, patients may be tired and/or confused, depending on the 
reason for their hospitalization. This physical deconditioning may be compounded by a lack 
of stimulation, which will be an aggravating factor, particularly in the first few days of 
hospitalization. Physiotherapists will be called in to help.  
 
Physiotherapists will ensure that senior citizens maintain good motor skills. Walking, 
transferring, moving around their living space and carrying out activities of daily living are 
essential to maintaining quality of life in the living environment of their choice. (Assessment 
of motor skills will be developed later). In addition to the intention to move, an important skill 
for elderly people is motor planning. Motor planning is the necessary step in building the 
basis of the motor program. The musculoskeletal system's redundancy means that the 
subject chooses a "typical movement" from among many possible alternatives. This motor 
planning seems to be impaired in some frail elderly patients (Kubicki & Mourey, 2015).. In 
this mission to recover motor skills, the physiotherapist must restore patients' ability to walk 
safely (self-assessment) and securely (physiotherapist's assessment) as soon as possible. 
To achieve this, and depending on the physiotherapist's assessment, various technical aids 
are available (Temfemo & Ahmaidi, 2018). These aids include the simple cane, the tripod 
cane, English canes, walkers with or without wheels etc. The physiotherapist will also need 
to pay attention to footwear. 
 
In fact, poorly adapted footwear may be experienced as unsafe and/or insecure by the team 
or the patient. Luk et al. (2015) offered a narrative review of fall prevention in the elderly. 
They advocate fall prevention interventions such as exercise, environmental modifications, or 
medication review. These authors also suggest taking an interest in patient footwear. They 
report on proposals to avoid high heels and use non-slip shoes, based on other studies 
(McKiernan, 2005; Menant et al., 2008).  
The footwear worn by elderly subjects on geriatric wards has also been studied by several 
teams. Vass et al. (2015) examined and described the type of footwear worn by elderly 
patients in hospital. They show that many patients wear footwear with insufficient structure to 
promote optimal stability or gait. Among the various types of footwear, they found non-slip 
socks for subjects living at home, in an institution or in hospital (Menant et al., 2008; Vass et 
al., 2015). A recent narrative review looked at the use of anti-slip socks to prevent falls in 
elderly patients (Hartung & Lalonde, 2017). In their conclusion, the authors do not 
recommend wearing socks for patients coming from home with limitations on the studies 
selected. One important limitation is the external validity of the studies, which are partly 
based on basic research. The other part, from clinical research, is not specifically concerned 
with our reference population. As a result, it is not possible for us to recommend whether or 
not non-slip socks should be worn by hospitalized senior patients. However, the question 
does arise under specific conditions, which we will describe in detail below. 
 
In clinical practice, in the short-stay wards of many hospitals, including CHD-Vendée, 
patients arrive from the emergency department with either no adapted footwear or no 
footwear at all. The emergency situation has brought them to hospital without giving them 
time to pack. In the case of direct hospitalization, a re-evaluation of footwear is also often 
necessary, in order to adapt footwear to the patient's situation. Other patients, particularly 
those with major cognitive impairment, who appear to be most at risk, regularly forget their 
shoes both during the day and at night. All in all, autonomy seems to be impaired by the 
absence of adapted footwear. When providing care (toileting, dressing, etc.), care assistants 
will move the patient into his or her chair, rather than having him or her walk to the toilet. In 
rehabilitation, the practitioner may choose not to take charge of a patient, or to offer partial 
care to avoid the risks associated with unsuitable footwear. The patient may be asked to 
walk on his or her own outside the rehabilitation program. 

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1.1.2. 
The aim of the study 
All in all, we can see that anti-slip socks may be of clinical interest. The scientific literature 
presents studies with methodological limitations, but above all a different population from the 
one we are interested in. It is therefore not currently possible to assess the specific benefit of 
anti-slip socks in an elderly hospitalized population. 
 
Evaluating the benefits of these socks could enable us to recommend them on the basis of 
solid data. Preventing this iatrogenic loss of autonomy would have a positive impact on 
patients' motor skills, a quicker and easier return home, and lower healthcare costs. 
 
We'd therefore like to know the benefits of wearing anti-slip socks in the management of 
these patients, and more specifically on the main objective of rehabilitation in geriatric 
physiotherapy: motor function. 
 
We believe that wearing non-slip socks improves patients' motor recovery. 
1.2. 
Benefits and risks for research subjects 
1.2.1. 
Benefits 
1.2.1.1. 
Individual profit 
Improved motor control 
Improved practices with the use of non-slip socks 
1.2.1.2. 
Group profit 
Improved motor care for senior citizens, at a lower cost to society thanks to a shorter length 
of stay, 
Improved motor management for faster discharge 
1.2.2. 
Foreseeable risks and constraints 
Constraints :  
For both groups, the only constraint added by the research is the specific tests to be taken 
and the questionnaire to be filled in. Patients will also be asked to use a wheelchair if they 
leave the hospital ward. 
For the experimental group, the additional constraint is the wearing of non-slip socks.  
 
Foreseeable risks : 
There is no increased risk associated with wearing anti-slip socks in senior patients. 
 

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1.2.3. 
Benefit/risk balance 
This study qualifies as interventional research with minimal risks and constraints, as defined 
in article L1121-1 of the French Public Health Code. On the basis of all the above-mentioned 
information, the benefit-risk balance of this study is favorably assessed.  
 
 

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2. OBJECTIVES AND JUDGING CRITERIA 
2.1. 
Objective and primary endpoint 
2.1.1. 
Main objective 
 
Assessing the impact of anti-slip socks on motor recovery in the elderly during 
hospitalization 
2.1.2. 
Primary endpoint 
 
Evolution of walking speed at the patient's preferred speed over 10m between D1 (start 
of physiotherapy treatment) and D8. Two tests will be performed at each assessment, and 
the average of the two tests will be used. 
2.2. 
Objectives and secondary endpoints 
2.2.1. 
Secondary objective(s) 
1. Assessing the impact of anti-slip socks on short-term motor skills 
2. Evaluate the impact of anti-slip socks on motor planning in the short term and during 
hospitalization 
3. Evaluate the impact of wearing socks on dual-task abilities in the short term and during 
hospitalization 
4. Evaluate the evolution of fear of falling with the use of socks in the short term and during 
hospitalization. 
5. Evaluate the impact of socks on the presence of fall(s)  
6. Length of stay in geriatric care or post-emergency medicine 
2.2.2. 
Secondary endpoints 
 
1. Change in 10m walking speed between D1 (start of physiotherapy treatment) and D1' 
("after a 3-minute walk with the shoe assigned following randomization"), 
2. Evolution of isochrony between the speed of walking actually performed and the speed of 
walking imagined over 10m at D1, D1' and D8. The mean of two tests of each modality 
will be used. 
3. Evolution of isochrony between walking speed and double-task walking speed over 10m 
at D1,D1' and D8 (Beauchet et al., 2010; Menant et al., 2014). The mean of two tests of 
each modality will be used. 
4. Total score > 10 on the Short-Falls Efficacy Scale International questionnaire at D1, D1' 
and D8 
5. Presence of fall(s) and their consequences during hospitalization 
6. Length of stay calculated from start of hospitalization to end of hospitalization 

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3. STUDY POPULATION 
3.1. 
Description of the population 
This study is aimed at patients admitted to the CHD Vendée in Post-Emergency Medicine 
and Geriatric Short Stay who require physiotherapy treatment. 
3.2. 
Inclusion criteria 

Patient in Geriatric Short Stay or Post-Emergency Medicine, 

Patient aged 75 and over, 

Patient requiring physiotherapy, 

Patient with at least 7 days of physiotherapy treatment 

Patient arrives with unsuitable footwear (assessment at clinician's discretion: no back 
support, unsuitable size, etc.) or no footwear at all, 

Patient able to walk at least 10 m with or without technical aids, 

Patient with oral consent 

Patient with social security coverage. 
3.3. 
Non-inclusion criteria 

Inability to understand or perform clinical tests specific to the study  

Known cognitive impairment, disease or condition that compromises comprehension 
of information or informed consent by the patient 

Blind patient 

Patients under guardianship or trusteeship 

Patient participating in an interventional clinical research protocol likely to modify the 
assessments of the present protocol.  

Patient previously included in the Charm study 

Patient with identified risk of being unable to wear socks or go barefoot within the 
next 7 days (need for compression stockings or socks, wound, excessive edema, 
orthostatic hypotension, other). 
 
 
The investigator/qualified person, or a person designated by the investigator/qualified 
person, must keep an up-to-date list of patients not included throughout the study. This list 
should include all patients from the population who do not meet the eligibility criteria. The list 
should also indicate, for each patient, the reason for non-inclusion in the study. 

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4. DESIGN AND STUDY PROCESS 
4.1. 
Study schedule 
4.1.1. 
Inclusion and baseline tests (J1) 
Patients arrive on the ward and are assessed by the doctor, who prescribes physiotherapy if 
necessary. 
The physiotherapist takes note of the prescription on the first working day thereafter. The 
physiotherapist carries out a routine analysis of the patient's footwear. If the footwear is 
unsuitable, or if the patient is barefoot, the physiotherapist checks the patient's eligibility 
criteria. If the patient meets these criteria, he or she is informed of the study. If the patient 
gives oral consent, the physiotherapist will perform the Baseline tests (D1).  
 
Baseline: J1 tests 
The physiotherapist assesses the patient during the first diagnostic session, and performs 
the Confusion Assesment Method if it has not been done in routine practice.  
 
A Visual Analogue Fatigue Assessment will be carried out prior to clinical testing. 
 
For research purposes, the J1 tests will be performed barefoot: 
1. Patient's walking speed over 10 m (2 times) 
2. Walking speed in dual-task situation over 10 m (2 times) 
Two other less common but validated assessments in this population will be carried out. 
3. Imagined walking speed over 10 m (2 times) 
The average of each of the two tests will be used for items 1 to 4.  
Together, these tests take the patient around 10 minutes. 
4. Short-Falls Efficacy Scale International Questionnaire 
 
4.1.2. 
Randomization 
Once the tests have been carried out, randomization will be carried out by the 
physiotherapist.  
 
Randomization arm : 

Control arm: usual care with bare feet. 

Experimental arm: specific management with non-slip socks. 
Depending on the randomization arm, the physiotherapist will put non-slip socks on patients 
in the experimental arm and leave patients in the control arm barefoot. He will then 
encourage the patient to walk for 3 minutes. 
 

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4.1.3. 
J1' follow-up 
After these 3 minutes of walking with or without the socks, depending on the randomization 
arm, and in order to assess the immediate effect of wearing anti-slip socks on motor skills, 
the patient will perform the same tests as on D1, in the same order.  
 
A Visual Analogue Fatigue Assessment will be performed prior to the following clinical tests: 
 
1. Patient's walking speed over 10 m (2 times) 
2. Walking speed in dual-task situation over 10 m (2 times) 
3. Imagined walking speed over 10 m (2 times) 
 
The tests will be carried out by the patient with bare feet (control arm) or with non-slip socks 
(experimental arm). 
4.1.4. 
Patient care procedures during the stay 
Following this second evaluation and for the duration of hospitalization, socks will be left on 
patients in the experimental arm, and patients in the control arm will remain barefoot. A 
notice will be posted in the patients' rooms to inform the nursing teams so that the 
randomization arm is respected. 
  
Between D1' and D8, the patient will undergo rehabilitation according to a pre-established 
plan based on the conclusions of the BDMK. The patient will benefit from 3 sessions, the first 
of which includes the assessment on D1. 
4.1.5. 
Follow-up J8 
 
At D8, in order to assess the effect of socks on motor preservation/recovery, the patient will 
be reassessed under the same conditions as at D1, i.e. barefoot, using the same tests as at 
D1 and in the same order.  
 
A Visual Analogue Fatigue Assessment will be performed prior to the following clinical tests: 
1. Patient's walking speed over 10 m (2 times) 
2. Walking speed in dual-task situation over 10 m (2 times) 
3. Imagined walking speed over 10 m (2 times) 
4. Short-Falls Efficacy Scale International Questionnaire 
 
 

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Study schedule 
Actions 
J1 
J1' (after 3 
minutes of 
free walking) 
J8 
Hospital 
discharge 
Patient information 
X 
 
 
 
Informed Consent 
X 
 
 
 
Checking inclusion and non-inclusion criteria 
X 
 
 
 
Randomization 
X 
 
 
 
Confusion Assessment Method 
X 
 
 
 
EVA fatigue 
X 
X 
X 
 
History (falls, MMSE, etc.)  
X 
 
 
 
Type of technical aid 
X 
X 
X 
 
Clinical examination 
X 
 
X 
 
Tests :  

Walking speed at patient's preferred 
speed over 10m (x2),  

Double-task walking speed over 10m 
(x2),  

Imagined walking speed over 10m 
(x2),  
X 
X 
X 
 
Short-FESI questionnaire 
X 
 
X 
 
Length of stay in geriatric care or post-
emergency medicine 
 
 
 
X 
 
 
.  
4.2. 
General research methodology 
The research has the following characteristics:  
- Open study, 
- Monocentric (CHD Vendée) 
- Controlled, 
- Superiority, 
- Randomized 
 
Inclusion period: 18 months 
Participation period: 7 days  
Research duration: 19 months maximum 
Number of patients to be randomized: 50  
 

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4.3. 
Study diagram 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Evaluation D1’ à 3 minutes 
Evaluation with Non-slip socks 
Consent and inclusion 
Eligibility criteria met 
1° bras :  
Non-slip socks 
2° bras : 
Barefoot 
Evaluation D8 
Barefoot 
Evaluation D1’ à 3 minutes 
Evaluation Barefoot 
Rehabilitation based on 
diagnostic assessment  
Rehabilitation based on 
diagnostic assessment  
Evaluation D1 
Barefoot
Randomization 

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4.4. 
Description and justification of the therapeutic 
regimen/method studied 
The aim of the study is to evaluate the effect of wearing non-slip socks on motor recovery. 
We have therefore chosen a design where we will be able to evaluate the evolution of motor 
skills between a control group and the experimental group wearing the socks. 
 
The non-slip socks used in this study (Appendix 3) will be those used in normal practice in 
our care department.  
These socks from CA Diffusion feature picot strips on the outer 2 sides for continuous grip, 
even when the sock is turned. They have a resistant interior to keep out the cold. They are 
latex-free to prevent allergies. 
Socks are changed every day to ensure good foot hygiene. They will be changed by the 
medical staff at the patient's bed.  
4.5. 
Description of evaluation and data collected 
4.5.1. 
Walking speed 
Walking speed is a common physiotherapy test used to assess motor function. It is easy to 
use, even for patients with cognitive and confusional disorders. Gait speed in patients over 
80 years of age is 0.943m/seconds ± 0.091 (Bohannon & Williams Andrews, 2011; Menant et 
al., 2014) 
The best initial estimates of small significant changes are close to 0.05 m/s for walking 
speed. (Perera et al., 2006) 
Substantial changes are of the order of 0.10 m/s (Perera et al., 2006). 
There are several ways of performing the test, at usual walking speed or at fast walking 
speed. For the purposes of this protocol, we have chosen the patient's preferred walking 
speed modality (Bohannon & Williams Andrews, 2011). 
Ground markings or studs provide visual cues for the patient. The patient stands facing the 
10m course, with visual cues to remind him or her of the course. 
The walking speed test will be performed twice. The instructions are : 
"At my starting marker, you'll have to walk at your usual speed to pass the marker".  
"Are you ready?" 
4.5.1. 
Double-task walking speed 
Double-task walking speed gives an indication of available cognitive reserve (Lundin-Olsson 
et al., 1997). Stopping walking or reducing walking speed by more than 30% is predictive of a 
fall (Beauchet & Berrut, 2006). 
 
Ground markings or studs provide visual cues. The patient stands facing the 10m course, 
with visual cues to remind him or her of the course. 
The walking speed test will be performed twice. The instructions are : 
"At my starting signal, you'll have to walk at your usual speed to pass the marker/plot on the 
ground. During this walk, you must name as many animals as possible. 
"Are you ready?" 

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4.5.2. 
Imagined walking speed 
Human movement can be separated into 2 phases, a programming phase (anticipation) and 
an execution phase (Jeannerod, 2001). The concordance between movement planning and 
execution can be reliably assessed using a simple test evaluating the temporal concordance 
between an imagined practice and a physical practice (Guillot et al., 2012).  This 
concordance is expressed by an Isochrony Index. Adapted to imagined walking speed, this is 
a simple test designed to assess motor prediction abilities (Rulleau et al., 2015).  
Interestingly, the decrease in isochrony correlates with the decrease in gait speed during the 
dual task (Bridenbaugh et al., 2013)). It could thus mark a risk of falling due to poor 
anticipation of actual motor abilities. 
 
Ground markings or studs provide visual cues. The patient stands facing the 10m course, 
with visual cues to remind him or her of the course. 
The imagined walking speed test is performed twice. The instructions are  
"At my starting signal, you'll have to imagine yourself walking at your usual speed to pass the 
marker/plot on the ground. When you imagine passing it, you'll say "stop". 
"Are you ready?" 
4.5.3. 
Fear of falling (Appendix 2) 
The Short-Falls Efficacy Scale International (Short-FES-I) is a patient-completed self-
questionnaire comprising 7 items with 4 possible answers. It has excellent internal 
consistency (Cronbach's alpha = 0.96 and 0.92) and test-retest reliability (ICC = 0.96 and 
0.83). The convergent construct validity of the Short-FES-I was confirmed for: previous falls; 
depressive symptoms; general disability; low quality of life; and physi-caloric impairment 
(Dewan & MacDermid, 2014). 
A threshold for fear of falling has been defined as > 10 on the Short-FES-I scale scale 
(Dewan & MacDermid, 2014). 
4.5.4. 
The presence of a fall 
The occurrence of a fall during hospitalization, the time of the fall and its consequences, and 
the total number of falls during the hospital stay will be recorded. 
Falls and dates of falls prior to hospitalization of less than 6 months will also be collected. 
4.5.5. 
Confusion Assesment Method (appendix 3) 
This tool is designed to be used by healthcare personnel, who search for 4 groups of clinical 
signs (Haute Autorité de Santé, 2009; Kharat & Simonet, 2013) : 
1. Sudden onset and fluctuating symptoms; 
2. Inattention; 
3. Disorganized thinking ; 
4. Impaired alertness. 
Diagnosis requires the presence of 3 of the 4 criteria. Criteria 1 and 2 are always required, 
along with 3 or 4 (Laplante & al, 2005,. Appendix 3). 

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4.5.6. 
Visual Analog Fatigue Scale 
The visual analog scale is commonly used in pain assessment (Hawker et al., 2011). In 
addition, other authors propose its use in fatigue assessment, using the same modality 
(Hewlett et al., 2011).. 
The slide is presented to the patient as follows: 
"I'm going to ask you to move the slider to your current level of fatigue. I'm going to ask you 
to move the cursor to your current level of fatigue". 
The operator rates fatigue from 0 to 100. 
4.5.7. 
Length of stay 
The length of stay in days and hours in geriatric short-stay or post-emergency medicine, 
calculated between the start of hospitalization and the end of hospitalization, will be 
recorded. 
4.6. 
Identification of all source data not contained in 
the medical record 
1. Confusion Assesment Method scale 
 
 
 
at D1 
2. Visual Analogue Fatigue Scale 
 
 
 
 
at D1, D1' and D8 
3. Type of technical aid(s)  
 
 
 
 
 
at J1, J1', J8 
4. Duration of 10 m walk (2 times) performed   
 
 
at D1, D1' and D8 
5. Duration of double-task 10 m walk (2 times) performed  
 
at D1, D1' and D8 
6. Duration of imagined 10 m walk (2 times) performed  
 
at D1, D1' and D8 
7. Short-Falls Efficacy Scale International questionnaire  
 
at D1, D1' and D8 
4.7. 
Rules for terminating a person's participation 
4.7.1. 
Criteria 
for 
premature 
termination 
of 
a 
person's 
participation in research 
A person's participation may be terminated prematurely for the following reasons: 
- Withdrawal of consent by the patient 
Patients will be able to withdraw their consent and ask to leave the study at any time, for any 
reason. 
- Death. 
4.7.2. 
Monitoring and data collection schedule 
Patients withdrawn from the study will not continue in the study schedule.  
 

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In the event of withdrawal of consent by the patient, and without prejudice to the patient's 
rights, the data already collected will be analyzed in accordance with regulatory texts.  
 
However, no other tests specifically provided for in the protocol will be carried out, and no 
data will be collected.  
 
Discharging a patient from the study program will in no way change his or her usual 
management of his or her pathology.  
4.7.3. 
Criteria for discontinuing all or part of a research project 
(excluding biostatistical considerations) 
Part or all of the study may be stopped permanently or temporarily by decision of the ANSM, 
the CPP and/or the study Sponsor.  
 
 In all cases :  
- A written confirmation will be sent to the investigator coordinating the study (specifying the 
reasons for premature termination) 
- All patients in the study will be informed.   
4.7.4. 
Patient management at the end of the research study 
Patients will be cared for according to the department's usual practices. 
4.8. 
COMPENSATION 
No compensation is provided for participation in this study. 

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5. SAFETY ASSESSMENT 
 
As the study corresponds to a category 2 RIPH (Research Involving the Human Person), the 
applicable vigilance measures are those put in place for the practice of care and the use of 
products associated with the study, in accordance with article L1123-10 of the French Public 
Health Code. The investigator will therefore be responsible for reporting the occurrence of 
any undesirable event, in accordance with the procedures applicable to the CHD Vendée. 

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6. DATA MANAGEMENT AND STATISTICS 
6.1. 
Study data collection and processing 
6.1.1. 
Data collection 
An observation notebook (eCRF) will be created for each patient. All information required by 
the protocol must be provided in the eCRF. It must include the data needed to confirm 
compliance with the protocol and all the data required for statistical analysis; it must also 
enable major deviations from the protocol to be identified. 
 
The person(s) responsible for filling in the eCRFs (investigator, CRA, etc.) must be defined 
and is/are identified in the task delegation form (kept in the investigator's folder). 
 
At the end of the study, the investigator will sign the eCRFs to certify the conformity of the 
data collected. 
 
6.1.2. 
Data coding 
By signing this protocol, the principal investigator/qualified person and all the members of his 
or her team undertake to keep confidential the identities of the patients who have participated 
in the study.  
 
The transmission of a person's data for research purposes will therefore only be possible if a 
coding system is used, and the presentation of research results will exclude any direct or 
indirect identification.  
 
Patients will be identified in order of inclusion by a number automatically assigned by the 
Ennov Clinical software (eCRF), then completed by the patient's initials (1st letter of first 
name + 1st letter of last name).  
 
This code will be the only information on the eCRF that can be used to link the eCRF to the 
patient.  
The investigator/qualified person is also required to code patient data on any documents 
he/she may have in his/her possession which are attached to the eCRF.  
 
A correspondence table will be set up at the participating center. This table will be kept in a 
secure place by the principal investigator/qualified person at the center, and will contain the 
patient code and nominative data, so that it can be traced back to the patient file in the event 
of missing or erroneous data. No clinical data will be collected in these correspondence 
tables. 
 
 
  

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6.1.3. 
Data processing 
The collection of clinical data will be based on the creation of a database and data entry 
masks similar to the observation book, in compliance with the protocol and regulations 
currently in force. 
 
6.2. 
Statistics 
Software 
Analyses will be performed using R software version 3.5.1 
 
6.2.1. 
Description of planned statistical methods, including 
schedule of planned interim analyses 
All variables will be described globally and by group. The description will include the number 
and percentage of modalities for qualitative variables, and the minimum, maximum, mean, 
standard deviation and median for quantitative variables. 
 
All gait speed criteria, isochrony between imagined and executed gait speed, isochrony 
between normal gait speed and double-task gait will be compared using linear models taking 
into account the baseline J1 value. 
 
As the evaluation conditions between D1' and D8 are different, the models evaluating 
evolution at D1' and D8 will be independent. 
Fear of falling will be assessed using the Falls Efficacy Scale International questionnaire. 
Fear of falling is defined with a cut-off score equal to 10 on this questionnaire.  
The number and percentage of patients with a fear of falling will be presented and compared 
at D1' and D8 using a Chi2 test. 
 
Length of stay will be compared using a Student's t test. 
 
The presence of falls and their consequences will be described during the hospital stay.  
 
6.2.2. 
Statistical justification of the number of inclusions 
Walking speed is a common physiotherapy test used to assess motor function. It is easy to 
use, even for patients with cognitive and confusional disorders. Gait speed in patients over 
80 years of age is 0.943m/seconds ± 0.091 (Bohannon & Williams Andrews, 2011; Menant et 
al., 2014) 
 
According to Perera et al. an improvement in walking speed of 0.10m/s is considered 
clinically relevant (Perera et al., 2006). 
For the purposes of this study, we therefore assume a difference of 0.10m/s between the 2 
groups, and a standard deviation of 0.10 for the difference. 

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Based on these assumptions, and for an alpha risk of 5% and power of 90%, a total of 46 
patients are required. To guarantee the power of the study, 50 patients will be randomized. 
 
6.2.3. 
Expected statistical significance 
The alpha risk is set at 5%. 
6.2.4. 
Statistical criteria for discontinuing research 
NA 
 
 
6.2.5. 
Method for taking into account missing, unused or 
invalid data 
All missing data and their reasons are described for each group. 
 
For the primary endpoint, if data are missing at D8, they will be imputed by the patient's 
baseline value (D1). 
If, for this criterion, more than 10% missing data are observed, a sensitivity analysis of the 
imputation method will be carried out: a multiple imputation method will be applied. 
6.2.6. 
Managing changes to the initial strategy analysis plan 
NA 
6.2.7. 
Choosing the people to include in analyses 
The main analysis will be carried out on the Intent-to-Treat (ITT) population, i.e. on all 
randomized patients. 
 
A complementary analysis will be carried out on the Per Protocol (PP) population, including 
randomized patients for whom no major protocol deviations have been identified. 
A data review meeting will be organized to review and define the major criterion or not for 
each deviation. 
 
6.2.8. 
Randomization 
Randomization will not be stratified  
It will be carried out in a 1:1 ratio and in blocks. 

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Randomization will be carried out in Ennov Clinical by connecting to the website: 
https://nantes-lrsy.hugo-online.fr/EnnovClinical/. The connection will be made using a login, a 
password and a study number, issued by the data manager of the Research Unit of the CHD 
La Roche sur Yon. The following information must be entered: 
 
-First initial of the name, 
 
-First initial of the first name, 
 
-Month and year of birth, 
 
Compliance with inclusion and non-inclusion criteria (yes/no), 
 
 
Randomization will be carried out by the physiotherapist or other authorized person after 
confirming the patient's inclusion in the study and obtaining oral consent. Randomization will 
be carried out prior to the D1 assessments. The inclusion number will be assigned 
automatically during randomization. An e-mail confirmation will be sent to the person who 
carried out the randomization, and to all those concerned. 
 
The randomization list will be drawn up by the biometrics team at the CHD La Roche sur Yon 
Research Unit. An explanatory guide to randomization will be available online at Ennov 
Clinical. 
 

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7. ADMINISTRATIVE AND REGULATORY ASPECTS 
7.1. 
Right of access to source data and documents 
The investigators will make available to those responsible for monitoring, quality control or 
auditing the research, the documents and individual data strictly necessary for this control, in 
accordance with the legislative and regulatory provisions in force (articles L.1121-3 and 
R.5121-13 of the Public Health Code). 
 
7.2. 
Data confidentiality 
Persons having direct access will take all necessary precautions to ensure the confidentiality 
of information relating to the persons concerned, in particular as regards their identity and the 
results obtained. 
These people, like the investigators themselves, are bound by professional secrecy (under 
the conditions defined by articles 226-13 and 226-14 of the French penal code). 
During or at the end of the research, the data collected on the subjects and transmitted by 
the participants will be pseudonymized. 
Under no circumstances may the names or addresses of the persons concerned appear in 
plain text.  
Only the first letter of the patient's surname, the first letter of the patient's first name and the 
year of birth are recorded, along with a coded number specific to the study, indicating the 
order of patient inclusion.  
 
7.3. 
Monitoring the study 
Monitoring will be carried out by the Promotion Department of the Research Division. A 
Clinical Research Associate (CRA) will regularly visit each site to check the quality of the 
data reported in the observation books. 
 
The monitoring plan is defined and adapted to the level of risk estimated for the patient 
undergoing research. It will be monitored as follows:  
Risk A: low or negligible foreseeable risk 
 
On-site monitoring visits will be organized by appointment with the investigator/qualified 
person. CRAs must have access to : 
- data collection notebooks for included patients, 
- patient medical and nursing records, 
- the investigator binder. 

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7.4. 
Inspection / Audit 
In the context of this study, an inspection or audit may take place. The sponsor and/or the 
participating center must be able to give access to the data to the inspectors or auditors. 
 
7.5. 
Delegation of tasks  
The principal investigator at the research site draws up and keeps up to date a task 
delegation form specifying the respective tasks he delegates to members of his team for the 
study, according to their competence. 
Each of the investigator's collaborators draws up an up-to-date, dated and signed curriculum 
vitae (CV).  
The investigator ensures that the collaborators to whom he delegates tasks within the 
framework of the study have the appropriate competence for these tasks. The investigator 
remains responsible for the conduct of research at the site. 
 
7.6. 
Declaration to the competent authorities 
The sponsor undertakes to submit the study project for prior authorization by a Comité de 
Protection des Personnes (CPP). The information provided covers the nature of the research 
and the safeguards provided for patients taking part in the study. The sponsor submits the 
curriculum vitae of the principal investigator at the research site to the CPP for its opinion. 
. 
 
 
The ANSM will also be informed of this protocol. 
 
7.7. 
Protocol amendments 
Requests for substantial modifications will be sent by the promoter to the relevant CPP for its 
opinion, in accordance with the law in force and its implementing decrees. 
 
An updated version of the modified protocol must be dated and signed. 
Information letters and the patient's oral consent form should be modified if necessary. 
 
 

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7.8. 
Computerized data and submission to the CNIL 
The data collected as part of this study is for scientific research purposes, in the public 
interest.  
 
This study falls within the scope of the "Reference Methodology" MR-001 registered, for the 
CHD Vendée, under n°2060482 v 0 for the following reasons:  
- Health data collection for research purposes  
- Obtaining the opinion of a CPP to begin research  
- Use of pseudonymized data 
- Individual information for data subjects  
- Access to data only by professionals (healthcare and sponsor) involved in the study.  
 
The fact that this study falls within the scope of MR001 and the reasons why will be notified 
in the sponsor's treatment register. 
 
7.9. 
Patient information 
7.9.1. 
Informed consent oral  
 
The investigator/qualified person undertakes to obtain the person's free, informed and 
express consent, obtained orally, after having provided information on the protocol. He/she 
will give the patient a copy of the information note. The person can only be included in the 
study after having read the information note and given oral consent, after having had time to 
reflect, if necessary.  
The patient's information and agreement to participate in the research must be recorded in 
his or her medical file. 
 
A record of the patient's express oral consent will be kept in the study documents.  
 
If the patient's next of kin is not present at the time of inclusion in the study, an explanatory 
triptych will be given to the patient's family (appendix 4).  
 
7.10. Financing and insurance 
The sponsor finances the study and takes out an insurance policy to cover the financial 
consequences of its civil liability, in accordance with regulations. 

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7.11. Publication rules 
The study will be registered on the Clinical trial open access website prior to the inclusion of 
the 1er patient in the study. 
 
The study may not be the subject of any written or oral comment without the agreement of 
the sponsor; all information communicated or obtained during the course of the study is the 
property of the CHD Vendée, which may freely dispose of it. 
 
All information resulting from this study is considered confidential, at least until appropriate 
analysis and control by the study sponsor, coordinator and statistician have been completed. 
 
Scientific papers and reports relating to this study will be produced under the responsibility of 
the study coordinator.  
 
The study coordinator will be the principal signatory of the communication and the editor of 
the documents, and will necessarily be one of the first or last authors. He/she may delegate 
this task to another person. 
 
The coordinating investigator draws up the list of authors. Investigators will be listed in 
proportion to the number of patients recruited. The study statistician will also be cited. 
 
Similarly, publications of ancillary results will include the name of the person who carried out 
the ancillary work, as well as the names of all other people involved in the ancillary work. 
 
All publications, abstracts or presentations including study results must be submitted to the 
sponsor (CHD Vendée) for approval. 
 
Publication rules will follow international recommendations (N Engl J Med, 1997; 336 :309-
315). .  
7.12. Archiving source data 
The investigator/qualified person must keep all information relating to the study for at least 15 
years after the end of the study. 
 
At the end of the study, the investigator/qualified person will receive a copy of each patient's 
data from the sponsor.  
No removal or destruction may be carried out without the agreement of the Promoter. At the 
end of the 15-year period, the Promoter will be consulted for destruction. All data, documents 
and reports are subject to audit or inspection. 
 

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