Effect of Educational Booklet for Foot-related Exercises for Prevention and Treatment of Foot Musculoskeletal Dysfunctions of People With Diabetic Neuropathy: FOotCAre (FOCAtrial-II) Randomized Controlled Trial
Phase: NA
Conditions: Diabetic Neuropathies
Sponsor: University of Sao Paulo General Hospital

 
 
Effect of Educational Booklet for Foot-related Exercises for Prevention and Treatment of Foot 
Musculoskeletal Dysfunctions of People With Diabetic Neuropathy: FOotCAre (FOCAtrial-II) 
Randomized Controlled Trial 
 
ClinicalTrials.gov Identifier NCT04008745 
 
Registered July 2, 2019.  
 

 
 
Aim 
The primary aim of this randomized controlled trial was to investigate the effects of an 8-
week home-based physiotherapeutic foot-ankle exercise program using an educational booklet 
on DPN symptoms and severity. The secondary goal was to investigate the effects of this 
intervention at 8 and 16 weeks on tactile and vibration sensitivities, foot health and functionality, 
foot muscle strength, functional balance, plantar pressure, foot-ankle kinematics, and lower 
limbs kinematics and kinetics during gait. 
 
Methods/Design 
Study design and data collection 
This trial is designed as a single-blind, two-parallel arms RCT, wherein patients with DPN 
will be randomly allocated to either a control group (CG) or an intervention group (IG). This trial 
protocol follows all recommendations established by SPIRIT (2013) [47], has been approved by a 
research ethics committee (CAAE: 90331718.4.0000.0065), and was registered at 
ClinicalTrials.gov on July 2, 2019 (identifier NCT04008745).  
Patients in the CG will not receive any specific intervention beyond the usual care, 
including treatment recommended by the medical team, pharmacological treatment, self-care 
guidelines, and a weekly telephone call to check on the adherence to care, which will be 
maintained in both groups [48]. Patients in the IG will perform a foot-related exercise program 
included in an educational booklet three times/week at home for 8 weeks. After 8 weeks, IG 

 
 
participants will be encouraged to continue this exercise until the end of the study following the 
same schedule set in the intervention period. If proven effective, the benefits of the foot-related 
exercises protocol will be explained and offered to all control participants at the end of the study. 
Patients from both groups will be evaluated for all outcomes at baseline (T0), 8 weeks 
(T8, end of intervention), and 16 weeks (T16, follow-up). All procedures in this study will follow 
the norms of the Operational Procedure Manual developed specifically for this research. The 
design and flowchart following the Consolidated Standards of Reporting Trials (CONSORT) 
guidelines [49] are presented in Fig. 1.  

 
 
 
 
 
Figure 1 -  Consolidated Standards of Reporting Trials (CONSORT) flow diagram illustrating the process of 
FOCA-II. 

 
 
Study Setting 
The participants allocated to the IG will be treated at their homes, but the first session 
will take place at the outpatient clinic of the Laboratory of Biomechanics of Human Movement 
and Posture (LaBiMPH). This clinic is located at the Physical Therapy, Speech and Occupational 
Therapy department of the School of Medicine of the University of São Paulo and assists all the 
physical therapy treatments of the laboratory, providing a reliable therapeutic environment for 
the first intervention. All assessments will be performed at the same laboratory.  
 
Participants and recruitment 
This study is currently recruiting patients (study start date: May 1, 2019) with a medical 
diagnosis of DM and DPN from the Department of Endocrinology of the Hospital das Clínicas of 
the School of Medicine of the University of São Paulo. Forty-eight participants with DPN will be 
recruited. The potential subjects will be interviewed by telephone and, once selected, assessed 
in the laboratory to confirm all eligibility criteria. This first laboratory assessment will represent 
the baseline condition (blind assessment). 
The inclusion criteria are adults up to 65 years of age of either sex diagnosed with DM 
type 1 or 2 with at least mild DPN confirmed by a fuzzy logic-based system [13], who are able to 
walk independently for at least 10 m, and who do not have more than one amputated toe (that 
is not the hallux). The exclusion criteria are the presence of an ulcer not healed for at least 6 
months and/or active ulcer; a history of surgical procedure to the knee, ankle, or hip or indication 
of surgery throughout the intervention period; arthroplasty and/or orthosis of lower limbs or 
indication of lower limb arthroplasty throughout the intervention period; diagnosis of other 

 
 
neurological disease outside of DM consequences; dementia or inability to give consistent 
information; receiving any physiotherapy or offloading devices throughout the intervention 
period; having major vascular complications and/or severe retinopathy; or having a score of 12–
21 (probable depression) on the Hospital Anxiety and Depression Scale (HADS). 
 
Randomization, allocation, and blinding 
The randomization schedule will be prepared using Clinstat software (University of York, 
UK) [50] by an independent researcher (Researcher #1) unaware of the numeric codes for the CG 
and IG groups. The numerical sequence will be kept in opaque envelopes, numbered sequentially, 
following an order generated by the software. The randomization procedure will follow the 
instructions of [51]. This sequence will be kept private and stored in a location inaccessible to 
blind assessors. 
After receiving the patients’ informed consent to participate, the random allocation to 
either the IG or CG will be made by another independent researcher (Researcher #2), who will 
also be unaware of the codes. Only the main research (Researcher #3) responsible for 
intervention training will know the group allocation of participants. Patients are aware of the 
treatment, thus not blind to the allocation. Researcher #3 will also be responsible for monitoring 
the intervention through weekly telephone calls and by checking the table in the booklet 
monthly. All patients’ personal data will be kept confidential before, during, and after the study 
by encoding participants’ names. Only the main researcher and the person receiving treatment 
will be aware of the meaning of each code. Patients will be allocated to study groups a maximum 
of one week after baseline evaluation. 

 
 
The envelope with the initially generated numerical sequence will then be opened, 
signed, and dated by the independent researcher, who will make the allocation (Researcher #2). 
Two other researches (Researchers #4 and #5), which will also be blind to treatment allocation, 
will be responsible for all clinical, functional, and biomechanical outcome assessments.  
To guarantee the blindness of the researchers, before each evaluation, patients will be 
instructed not to reveal whether they are in the CG or IG; their questions should be asked only 
for the main researcher (Researcher #3). All researchers will be blind to the block size used in the 
randomization procedure. The trial statistician will also be blind to treatment allocation until the 
main treatment analysis has been completed.  
 
Treatment arms 
Control  
CG patients will not receive any specific intervention other than the treatment 
recommended by the health care team, which will include pharmacological treatment and self-
care guidelines following the International Working Group on the Diabetic Foot guide [52]. These 
self-care guidelines have been adjusted for our setting in Sao Paulo and include (1) instructing 
patients to inspect their feet and inside of shoes daily, wash feet daily (with careful drying, 
particularly between toes), avoid using chemical agents or plasters to remove calluses or corns, 
avoid cutting calluses or blisters without supervision, use emollients to lubricate dry skin, and cut 
toe nails straight across; (2) instructing patients to use socks without elastic and sewing; (3) 
instructing patients to avoid walking barefoot or wearing shoes without socks or slippers and to 
seek medical assistance whenever identifying problems in their feet; and (4) providing education 

 
 
aimed at improving footcare knowledge and behavior as well as encouraging the patient to 
adhere to this footcare advice. These guidelines will be maintained for both groups. Patients in 
this group will also receive a weekly telephone call to check the adherence to the care 
recommended by the medical staff and the foot care guidelines and to avoid the nocebo effect. 
 
 
Intervention  
IG patients will receive an educational booklet with two parts. The first part includes 
educational information to guide the individuals to change their health behavior regarding 
autonomous footcare, with information about DPN, footwear, and benefits of exercising the 
foot-ankle. The second part includes a home-based physiotherapeutic foot-related exercise 
program comprised of six exercises.  
Before starting the exercises protocol, the patients will be instructed by the main 
researcher on how to perform the exercises using the booklet. The first session will be supervised 
at the outpatient clinic of the Department of Endocrinology of the Hospital das Clínicas, providing 
a reliable therapeutic environment for the first intervention. 
The exercise program includes strengthening of the intrinsic foot muscles and the 
extrinsic foot-ankle muscles, and it consists of the following steps:  
(1) Warm-up: The patients will warm up the foot-ankle with three exercises. They will be 
instructed to massage their feet, and then use a spiky ball to do a deep tissue massage, 
and subsequently perform rotating movements in each toe, one by one. Altogether, these 
exercises should be performed within 2–3 minutes. 

 
 
(2) A total of six exercises will be performed: four exercises for the intrinsic foot muscles and 
two for the extrinsic foot-ankle muscles. The exercises will be performed in the order 
suggested by the booklet using objects such as cotton, pencil, balls, and chairs. The 
interphalangeal, metatarsophalangeal, and ankle joints are targeted in the protocol. The 
following muscle groups are targeted in protocol: medial-plantar aspect (abductor 
hallucis, flexor hallucis brevis, and adductor halluces), lateral-plantar aspect (abductor 
digiti minimi, flexor digiti minimi brevis, and opponens digiti minimi), middle-plantar 
aspect (flexor digitorum brevis, quadratus plantae, lumbrical muscles, plantar 
interosseous, and dorsal interosseous muscles), and dorsal-foot aspect (extensor 
digitorum brevis and extensor hallucis brevis). 
 
The foot-related exercises will first be performed in the sitting position in one set with 30 
repetitions. If the patient finds this too easy, the exercise will then be performed in the standing 
position, and then standing on one foot. The patient can also increase the number of sets. 
Patients will follow the exercise program from the booklet with instructions for each exercise 
prescribed, and after each task, they will fill out a table stating the perceived effort for each 
exercise (using a Likert scale). At the end of each exercise, patients will define their effort using 
a visual analogue scale (VAS). If the effort is between 0 and 5, the individual should progress to 
the next level of the exercise (e.g., from sitting to standing, or using a different object) for the 
next session. If the effort is between 6 and 8, the same volume and level of difficulty should be 
maintained. If the effort is between 9 or 10, the amount of repetitions should be decreased or 

 
 
the position in which the exercise is performed should be modified (e.g., from standing to sitting) 
(see Additional File 1).  
Patients will follow this regime three times a week for 8 weeks, for a total of 24 sessions. 
The duration of a session should be no longer than 30 minutes. The perceived effort scale will be 
used to regulate each patient’s individual effort for his/her progression to the next session of 
exercises, and it will be recorded by the participant using the monthly table in the booklet (see 
Additional File 1).   
The discontinuation criteria for the exercises include cramps, moderate to intense pain, 
fatigue, or any other condition that exposes the patient to any discomfort. The other 
discontinuation criterion for the intervention is the occurrence of a foot ulcer as assessed by a 
blinded podiatrist nurse specializing in diabetic feet. The patients will be advised to report any 
sign of tissue damage to Researcher #3. 
 
Outcomes and measures 
Two researchers (Researchers #4 and #5) who are blinded to group allocation will perform 
all assessments. Participants of both groups will be assessed at baseline (T0), at the end of 
intervention (T8, 8 weeks after baseline), and at follow-up (T16, 16 weeks after baseline). Table 
1 shows the schedule of enrollment, intervention, and assessments according to the SPIRIT 
guidelines [47].  

 
 
Table 1 - Schedule of enrollment, intervention, and assessments of the FOCAtrial-II, following 
SPIRIT guideline 
TIMEPOINT Enrollment Allocation 
Post-allocation 
Follow-
up 
 
T-1 
T0 
T0 
T8 
T16 
Eligibility screen 
X 
 
 
 
 
Informed consent  
X 
 
 
 
 
                   Allocation 
 
X 
 
 
 
INTERVENTIONS 
 
 
 
 
 
Intervention Group 
 
 
 
Control Group 
 
 
 
 
ASSESSMENTS 
 
 
 
 
 
DPN symptoms 
 
 
X 
X 
X 
Fuzzy classification of the DPN severity 
 
 
X 
X 
X 
Foot- ankle kinematics and kinetics 
during gait 
 
 
X 
X 
X 
Dynamic plantar pressure distribution 
during gait 
 
 
X 
X 
X 
Tactile sensitivity  
 
X 
X 
X 
Vibration sensitivity 
 
 
X 
X 
X 
Foot health and functionality  
 
X 
X 
X 
Foot isometric strength 
 
 
X 
X 
X 
Functional balance 
 
 
X 
X 
X 
 
An initial anamnesis will be performed to check the eligibility criteria, including clinical, 
anthropometric, and demographic characteristics of all participants. The classification of DPN 
severity will be made using the fuzzy score from a web software program [13,53]. Participants 
with scores equal to or above 2.0, corresponding to mild DPN, will be included in the study. Those 
who score between 12 and 21 (probable depression) on the Brazilian-Portuguese HADS will not 
be included [54].  
The DPN symptoms and the classification of the DPN severity will be the primary 

 
 
outcomes. The foot-ankle kinematics and kinetics during gait, plantar pressure distribution 
during gait, tactile and vibration sensitivities, foot health and functionality, foot strength, and 
functional balance will be the secondary outcomes. 
 
DPN symptoms 
Patients will answer the Brazilian version of the Michigan Neuropathy Screening 
Instrument (MNSI) [55]. This questionnaire has 15 questions about the sensitivity of the feet and 
legs and is self-administered. A score of 1 point is given for answers of “yes” for questions 1, 2, 
3, 5, 6, 8, 9, 11, 12, 14, and 15 and “no” for questions 7 and 13. Questions 4 and 10 evaluate 
circulatory deficits and general asthenia, respectively, and neither are included in the final score. 
The sum of all scores ranges from 0 to 13, and the larger the score, the worse the DPN. 
 
Fuzzy classification of the DPN severity 
The classification of the DPN severity will be made using the Decision Support System for 
Classification of Diabetic Polyneuropathy [13,53] developed by the LaBIMPH and publicly 
available at: http://www.usp.br/labimph/fuzzy/. This decision will be based on fuzzy logic with 
the input variables of signs and symptoms extracted from the MNSI as well as tactile sensitivity 
(through the number of non-touch areas using a 10-g monofilament) and vibration sensitivity (by 
vibrating a tuning fork at 128 Hz), characterized as absent, present, or diminished. The software 
gives a score from 0 to 10, with higher scores indicating more severe DPN. 
 
Foot-ankle kinematics and kinetics during gait 

 
 
Gait kinematics will be assessed by three-dimensional displacements of passive reflective 
markers (9.5 mm in diameter) tracked by eight infrared cameras at 100 Hz (VERO, Vicon Motion 
System Ltd., Oxford Metrics, UK) and the NEXUS 2.8 motion capture software (Vicon Motion 
System Ltd.). Forty-two markers will be placed on both limbs of the subject (pelvis, thigh, leg, 
ankle, and foot) according to the Plug-In Gait and Oxford Foot Model [56] setup protocols. The 
laboratory coordinate system will be established at one corner of the force plate, and all initial 
calculations will be based on it. Each lower-limb segment (shank and thigh) will be modeled based 
on surface markers as a rigid body with a local coordinate system that coincides with the 
anatomical axes. Translations and rotations of each segment will be reported relative to the 
neutral positions defined during the initial static standing trial. All joints will be considered to be 
spherical (i.e., with three rotational degrees of freedom). Ground reaction forces will be acquired 
by a force plate (AMTI OR-6-1000, Watertown, MA, USA) embedded in the center of the 10-m 
walkway at 1 kHz. Force and kinematic data acquisition will be synchronized and sampled by an 
A/D board (Control Box LOCK VICON, 192 kHz, 24 bits). 
Participants will be asked to walk at their comfortable, self-selected speed, with a 
maximum variation of 5% between measurements, thus ensuring that the same speed is 
maintained in all assessments (T0, T8, and T16). After a complete habituation to the laboratory 
environment, 10 valid steps will be acquired on each side during gait. 
The automatic digitizing process, 3D reconstruction of the markers’ positions, and filtering 
of kinematic data will be performed using the NEXUS software. Kinematic data will be processed 
using a zero-lag second-order low-pass filter with cutoff frequency of 6 Hz. Ground reaction force 

 
 
data will be processed using a zero-lag low-pass Butterworth fourth-order filter with cutoff 
frequency of 50 Hz. 
The bottom-up inverse dynamics method will be used to calculate the ankle moments in 
the sagittal plane. For the calculation of ankle power, the calculated joint moment and the ankle 
angular velocity in the sagittal plane will be considered. Calculation of all discrete variables from 
the time series obtained will be performed using a custom-written MATLAB function 
(MathWorks, Natick, MA, USA). 
The following kinematic variables will be analyzed for the stance phase: (a) sagittal ankle 
ROM, (b) ankle dorsiflexion at heel strike, (c) ankle plantarflexion at push off, (d) hindfoot to 
forefoot rotation ROM, (e) transverse plane ROM between first and second metatarsal bones and 
between second and fifth metatarsal bones, and (f) deformation of the longitudinal medial arch. 
The ankle kinetic variables to be analyzed are: (a) flexor moment and eccentric power at heel 
strike and (b) extensor moment and power at approximately 80% of stance phase, corresponding 
to the propulsion phase. 
 
Plantar pressure distribution during gait 
A 700 × 403 × 15.5-mm pressure platform (emed q-100, GmbH, Novel, Munich, Germany) 
with 6080 sensors (four sensors per cm2) will be used to acquire plantar pressure data during gait 
at 100 Hz. Participants will walk barefoot three times over the platform with a self-selected gait 
speed (same as in the kinematic trials), covering a distance of 4 m. Both feet will be analyzed for 
each patient. Based on the algorithm by Giacomozzi [57], peak pressure, contact area, and 
pressure-time integral in seven anatomical plantar regions—heel, midfoot, medial forefoot, 

 
 
medium forefoot, lateral forefoot, hallux, and toes—will be analyzed. This method relies on the 
integration of a 3D motion capture system (Vicon system), a pressure measurement device 
(emed q-100), a multi-segment foot model, and an algorithm to identify regions of interest. 
 
Foot muscle isometric strength 
Foot muscle isometric strength of the flexor muscles of the hallux and lesser toes will be 
measured according to Mickle [58] using a pressure platform (emed q-100). Subjects will stand 
and push down on the platform as hard as possible with the toes and hallux, controlling for 
excessive body sway. The plantar regions corresponding to the hallux and the toes will be 
identified by a standard mask from Novel-win Multimask software v. 9.35. The average of three 
trials on each foot (left and right) will be used for statistical purposes.  The outcomes will be the 
maximum force under the hallux and toes, normalized by bodyweight.  
 
Tactile sensitivity 
Tactile sensory deficits will be assessed by a 10-g monofilament [48] in four plantar areas 
(plantar surface of the hallux and heads of the first, third, and fifth metatarsals). This instrument 
has good reliability and validity in elderly individuals [59]. The monofilament will be applied 
perpendicularly to the skin surface three times on the tested areas with sufficient force to cause 
the filament to bend or buckle. The sequence of the tested areas will be randomized. The patient 
will not be able to see the monofilament or where it is being applied. The number of areas in 
which the patient does not feel pressure will be recorded [60]. The greater the number of areas 
marked, the greater the impairment of tactile sensitivity. 

 
 
 
Vibration sensitivity 
Vibration testing will be conducted with the timed method using a 128-Hz tuning fork 
applied to the dorsal surface of the distal phalanx of the hallux. The time (in seconds) at which 
vibration sensation diminishes beyond the examiner’s perception will then be recorded from 
both sides on a standardized form [61]. Values less than 10 s will be classified as present vibratory 
sensitivity, greater than 10 s will be classified as decreased vibratory sensitivity, and no 
perception will be classified as absent vibratory sensitivity. 
 
Foot health and functionality 
The Brazilian-Portuguese version of the Foot-Health Status Questionnaire (FHSQ-BR), 
which has been translated and validated by [62], will be used. This questionnaire is divided into 
three domains, and we will use Domains I and II. These domains are comprised of questions with 
answer options presented in affirmative sentences and corresponding numbers. Domain I 
evaluates foot health in four dimensions: foot pain, foot function, footwear, and general foot 
health. Domain II evaluates the general state of health, also in four dimensions: general health, 
physical activity, social capacity, and vitality. Domain III collects general demographic data. The 
domain I and II has a score from 0 to 100 points, where 100 is the best condition and 0 is the 
worst. The scores will be calculated using the FHSQ software version 1.03 (Care Quest, Australia). 
 
Functional balance measure 
The functional balance assessment will be performed according to [63] using the 

 
 
Functional Reach Test (FRT). Subjects will be asked to assume a standing position without shoes 
or socks. Patients will be asked to stand with their shoulders perpendicular to the reach 
measurement device (measuring tape), which will be attached to the wall and parallel to the floor 
at the height of the patient’s acromion. The upper extremity should not contact the wall during 
the task. In order to maintain identical foot placement during all testing conditions, the foot 
position will be traced on a sheet attached to the surface of the floor. The initial measurement 
(Position 1) will correspond to the position where the third metacarpal is in the beginning of the 
measuring tape and end of the measurement is where the third metacarpal achieve in the 
measuring tape after the forward movement (Position 2). The patient will then be instructed to 
lean forward as much as possible without losing balance, flexing the hips, or taking a step. 
Functional reach will be defined as the mean difference between Positions 1 and 2. Three trials 
will be performed, and the average score will be used for statistical purposes. The greater the 
distance achieved, the better the functional balance. 
 
Statistical Analysis Plan  
The sample size was calculated using the GPower v. 3.1 program [64] based on the 
following outcomes: MNSI DPN symptoms (primary) and ankle sagittal ROM during gait 
(secondary). These two outcomes were chosen because they reflect important functional gains 
for DPN patients. Thus, two sample size calculations were performed, and we selected the one 
that resulted in the largest number of participants. The effect sizes used for both calculations 
were based on a study that evaluated the effect of 12 weeks of supervised foot exercise in DM 
patients [34]. In that study, the improvement in the MNSI symptoms had a medium effect size 

 
 
(0.52), as did gains in the ankle sagittal ROM during gait (0.46). We chose to use half of the effect 
size obtained in [34] because the nature of our intervention is home based, whereas Sartor’s was 
face-to-face, which is assumed to be more effective. 
The input factors for sample size calculation were a statistical design of F-test with 
interaction between and within factors with two repeated measures and two study groups, 
statistical power of 0.80, alpha of 0.05, and effect sizes of 0.26 (MNSI symptoms) and 0.23 (ankle 
ROM). The resulting sample sizes were 32 and 40 individuals for MNSI and ROM outcomes, 
respectively. Therefore, we defined our sample size as 40. Assuming a 20% dropout rate during 
the study, a sample size of 48 patients is needed. 
Inferential statistical analyses will be conducted using intention-to-treat and per protocol 
analyses. The missing data will be treated by imputation methods depending on the type: missing 
completely at random, missing at random, or not at random [65]. The per-protocol analysis will 
include only those patients who complete follow-up in the allocated intervention group. 
Confirmation of normality (Kolmogorov–Smirnov test), homoscedasticity (Levene test), and 
imputation of the means for the missing data of variables with normal distribution will be 
conducted. After that, mixed general linear models of analysis of variance for repeated measures 
will be used to detect treatment–time interactions, followed by Newman–Keuls post hoc test to 
obtain group effect (intervention and control), time effect (between T0, T8, and T16), and group–
time interaction. Significant differences will be considered at α = 5%, but for the description of 
the effect of the intervention, the effect size (Cohen coefficient) and difference between the 
means will be calculated with their respective 95% confidence intervals.  
 

 
 
Ethics approval and consent to participate  
This trial was approved by the Ethics Committee of the School of Medicine of the University of 
São Paulo (CAAE: 90331718.4.0000.0065), according to the Declaration of Helsinki Ethical 
Principles for Medical Research Involving Human Subjects. The trial was registered at 
ClinicalTrials.gov (a service of the US National Institutes of Health) with identifier NCT04008745 
(2 July 2019) under the brief title “ Effect of Educational Booklet for Foot-related Exercises for 
Prevention and Treatment in People with Diabetic Neuropathy (FOCA-II)”. The main researcher 
will explain to each eligible participant every step of the assessment and follow-up, the possible 
risks, and the fact that no compensations or benefits are to be expected. When agreeing to 
participate, participants will be asked for written informed consent, according to the standard 
forms. On the consent form, participants will be asked if they agree to use their data in the study; 
if they do not agree, they can choose to withdraw from the trial. Participants will also be asked 
for permission for the research team to share relevant data with people from the University 
taking part in the research or from regulatory authorities, where relevant. Any changes made to 
the protocol will be amended and communicated via a report sent to the sponsor and funder. 
The ethics committee will also be notified by submission of a form via the national website of the 
research ethics committee, http://plataformabrasil.saude.gov.br/. Changes will also be included 
in the clinical trial register (https://clinicaltrials.gov/). This trial does not involve collecting 
biological specimens for storage. 
 
 
 

 
 
 
ETHICS COMMITTEE OPINION 
 
Title: Rehabilitation technology for musculoskeletal dysfunctions prevention and treatment of 
feet of people with diabetes: Randomized controlled trials FOotCAre (FOCA) 
Responsible: Isabel C. N. Sacco 
Institution: School of Medicine, University of Sao Paulo 
CAAE: 90331718.4.0000.0065  
Main funding:  CNPq funding 407252/2018-5 
 
DADOS DO PARECER  
 
Number of the process: 3.319.047 
Project Presentation: 
This is a project on a highly relevant topic that has the potential to positively impact the health 
of diabetic patients. 
Objective of the project:  
To apply rehabilitation technology for prevention of musculoskeletal dysfunctions and treatment 
for persons with diabetes: randomized controlled trials FOotCAre (FOCA). 
Risk and Benefit Assessment:  
Risks are acceptable and small against benefits.  
Comments and Considerations about the project: Relevant research with no obvious limitations 
Mandatory Terms Considerations: Suitable 
Recommendations: none 
Conclusions or To-Do List and Inadequacy List: approve 
Opinion Status: Approved 
Needs CONEP Appraisal: No 
Sao Paulo, May 10th 2019. 

 
 
 

 
 
INFORMED CONSENT FORM 
 
Research project: “Effect of Educational Booklet for Foot-related Exercises for Prevention and 
Treatment 
in 
People 
With 
Diabetic 
Neuropathy 
(FOCA-II)”, 
____________________________________, 
___________________________________________ agree to participate in the research 
conducted by Profa. Dr. Isabel de Camargo Neves Sacco, by MSc. PT. Érica Queiroz da Silva, Jane 
Suelen Silva Pires Ferreira, Renan Lima Monteiro, PT. Ronaldo Henrique Cruvinel Junior and OT. 
Jady Luara Veríssimo of the Laboratory of Biomechanics of Movement and Human Posture 
(Labimph) of the Department of Physiotherapy, Speech Therapy and Occupational Therapy 
(FOFITO), Faculty of Medicine (FMUSP), University of São Paulo (USP). The results, with proper 
identification and confidentiality, will be analyzed and used solely for scientific purposes. 
This project aims to evaluate the efficacy, safety and adherence of the use of rehabilitation 
technologies by through a foot and ankle exercise booklet and their effects on gait kinematic and 
kinetic responses, diabetic polyneuropathy, functional foot responses. and lower limbs and 
balance. 
Explanation of Procedures: 
 
● Step 1: 
This stage will take place at USP's Laboratory of Human Movement and Posture Biomechanics, 
located in the University City and has questionnaires, an assessment of your gait and the strength 
and health of your feet. You will be interviewed to evaluate the signs and symptoms of diabetic 
polyneuropathy. You will complete a questionnaire that will assess the health of your feet. For 
gait assessment, we will place markers (silver balls) at certain points on your body and you will 
sometimes walk around the lab. The strength of your feet will be assessed with you standing by 
moving your toes against a platform of pressure. To check for vascular disease, blood pressure at 
your ankle and arm will be measured. Finally, we will inform you if you will be part of the group 
that will receive by a booklet the physical therapy treatment or if you will be part of the group 
that will not receive the treatment. 
 
● Step 2: 
The treatment will last 08 weeks of use of the booklet, 3 times a week. Weekly calls will be made 
to track technology usage. After 08 weeks of use of the technology, patients will continue to 
exercise at home independently, following the same study protocol, until the end of the study 
(after sixteen weeks of initial assessment). 
 
● Step 3: 
You should return to the Biomechanics Laboratory of the FOFITO after 08 weeks and 16 weeks 
from the study start date to evaluate your strength, gait speed and application of the same 
questionnaires at the first visit.  
 
Discomfort and Risk: This research offers minimal risks that are the same as those found in normal 
activities that you perform daily. Any pain or discomfort that arises at the time of the assessment 
and the use of the tools, the assessment will be immediately interrupted and you should stop 

 
 
performing the proposed exercises and immediately inform the research staff. If you have any 
damage caused by the practice of the exercises, you will be compensated by the survey as 
provided for in resolution 466 of December 12, 2012, which provides material damage repair 
coverage for the survey participant. 
 
Benefits: If you are drawn to the intervention group, you will receive a free 8-week physiotherapy 
treatment, supervised by telephone calls for 08 weeks during the study period. If you are drawn 
to the control group (without treatment), you will contribute to understanding the importance 
of the feet and ankles in the health of neuropathic patients. After 16 weeks, you may have access 
to the same physical therapy treatment as the intervention group. 
 
Guaranteed access: At any stage of the study you will have access to the professionals responsible 
for the research to answer any questions. The main investigator is Profa. Dr. Isabel de Camargo 
Neves Sacco to be found at the Laboratory of Human Movement and Posture Biomechanics, 
Department of Physical Therapy, Speech Therapy and Occupational Therapy, 51 Cipotânea 
Street, University City (phone 3091-9426) If you have any questions or concerns about research 
ethics, contact the Research Ethics Committee (CEP) - Ovídio Pires de Campos Street, 225 - 5th 
floor - tel: 3069-6442 extensions 16, 17, 18 or 20, FAX: 3069-6442 extension 26 - Email: 
cappesq@hcnet.usp.br.  
 
Freedom to withdraw consent at any time and to cease participating in the study is guaranteed, 
without prejudice to the continuity of their treatment at the Institution. 
 
It is your right to be kept up to date on the partial results of research, when in open studies, or 
of results that are known to researchers. 
 
Cost and Compensation: There are no personal costs for the participant at any stage of the study, 
including consultations and evaluations. There is also no financial compensation related to your 
participation. If there are any additional costs, as well as transportation and / or food, it will be 
absorbed by the research budget, as provided in resolution 466 of December 12, 2012. 
 
The results will be kept with their proper identifications and kept confidential, which will be used 
solely for scientific purposes. 
 
I believe I have been sufficiently informed about the information I have read or read to me, 
describing the study that aims to assess the effectiveness, safety and adherence of using 
rehabilitation technologies through a foot and ankle exercise booklet and their effects on 
kinematic and kinetic responses in gait, diabetic polyneuropathy, foot and lower limb functional 
responses and balance. 
 
I discussed with those responsible: Prof. Dr. Isabel de Camargo Neves Sacco and/or MSc. Érica 
Queiroz da Silva, Jane Suelen Silva Pires Ferreira, Renan Lima Monteiro, PT. Ronaldo Henrique 
Junior Cruvinel or OT. Jady Luara Veríssimo about my decision to participate in this study. It was 
clear to me what are the purposes of the study, the procedures to be performed, its discomforts 

 
 
and risks, guarantees of confidentiality and permanent clarification. It was also clear that my 
participation is free of charge and that I am guaranteed access to hospital treatment when 
necessary. I voluntarily agree to participate in this study and may withdraw my consent at any 
time before or during it without penalty or loss or loss of any benefit I may have acquired or in 
my service on this Service 
 
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Patient Signature / Legal Representative                                                                    Date          /    / 
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Witness Signature                                                                                                            Date          /    / 
(Only the project leader) 
I declare that I have appropriately and voluntarily obtained the Informed Consent Form of this 
patient or legal representative to participation in this study. 
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Project Leader Signature                                                                                                Date          /    /