Improvement of Motor Imaginative Ability Through Functional Electrical Stimulation
Phase: EARLY_PHASE1
Conditions: Electrode Site Reaction, Therapy, Directly Observed
Sponsor: Universidad de Burgos

Report  request  to  the  Bioethics  Commission
Project  memory:
A/A  of  the  President  of  the  Commission
1.-  Introduction/Justification
Bioethics  of  the  University  of  Burgos
Juan  Hilario  Ortiz  Huerta
Researchers:  Montserrat  Santamaría  Vázquez
Motor  imagination  (MI)  is  defined  as  the  cognitive  process  of  imagining  the  movement  of  a  part  of  a  
person's  own  body  without  actually  moving  that  part  of  the  body  (Al-Saegh  et  al.,2021).
MOTOR  IMAGINATION  THROUGH  FUNCTIONAL  ELECTRICAL  STIMULATION
MANUAL  WEEDING,  THROUGH  ELECTRICAL  STIMULATION
Project  report  is  attached  for  your  evaluation.
FUNCTIONAL
1
EXPOSES:
Type  of  work:  Research  work.
Title  IMPROVEMENT  OF  THE  CAPACITY  OF  MOTOR  IMAGINATION  AND
What  does  the  project  titled:  IMPROVEMENT  OF  THE  CAPACITY  OF
Olalla  Saiz  Vazquez
The  research  question  of  this  work  is  based  on  seeing  if  the  relationship  between  IM  and  the  
aforementioned  parameters  also  occurs  the  other  way  around.  Could  improving  strength  and/or  manual  
dexterity  also  improve  IM?
IM  training  in  healthy  adults  has  been  shown  to  improve  strength,  arm  positioning  speed,  and  joint  range  
(Dickstein  and  Deutsch,  2007).  On  the  other  hand,  the  capacity  of  MI  has  been  shown  to  be  related  to  
proprioception.  Shenton  et  al  (2004)  have  suggested  that  proprioception,  in  some  circumstances,  may  
represent  an  important  input  at  the  sensory  level  that  contributes  to  the  representation  of  the  body;  
Furthermore,  McCormick  et  al  (2007)  have  suggested  that  altered  proprioceptive  input  could  alter  MI  
tasks.
Aitor  Martín  Odriozola
Mr.  MONTSERRAT  SANTAMARÍA  VÁZQUEZ,  with  ID  13156556G,  and  contact  telephone  number  
630569820.
Neuromuscular  electrical  stimulation  ( NMES)  is  an  application  of  electrical  stimulation  used  in  movement  
rehabilitation  Stein  et  al
Machine Translated by Google

A/A  of  the  President  of  the  Commission
The  study  aims  to  answer  the  PICO  research  question:
I:  FES  and,  multifield  FES.
Bioethics  of  the  University  of  Burgos
Q:  healthy  adults
The  Fesia  Grasp  system  is  a  FES-based  neurological  hand  rehabilitation  device  developed  by  Fesia  
Technology  (Donostia-San  Sebastián,  Spain).  This  is  a  commercial  device  designed  for  manual  
dexterity  rehabilitation,  which  delivers  a  train  of  biphasic  pulses  of  different  widths  and  amplitudes  to  
different  electrode  fields  asynchronously,  meaning  that  different  electrode  fields  are  activated  with  an  
interval  predefined  between  pulses  Maleševiÿ  et  al  (2017).
Fesia  Grasp,  generates  superficial  electrical  stimulation  of  the  forearm  muscles  to  trigger  eight  
different  flexion  and  extension  movements  of  the  wrist  and  fingers  in  order  to  restore  the  function,  
freedom  and  independence  of  the  patient's  hand  after  a  stroke,  Martin  -Odriozola  et  al  (2021).
The  aim  is  to  compare  different  tools  in  a  population  sector  to  check  if  there  is  an  improvement  in  
motor  skills  through  the  use  of  FES.
increased  muscle  strength,  remission  of  osteopenia  and  improved  walking  (Bélanger  et  al,  2000;  
Sabut,  2011).
2
FES  device  technology  has  traditionally  been  based  on  conventional  electrodes.  However,  multi-field  
surface  electrodes  have  emerged,  consisting  of  groups  of  several  small  conductive  fields,  which  can  
be  activated/deactivated  and  configured  independently  (FesiaGrasp,  2022).
(1992).  Functional  electrical  stimulation  ( FES)  is  a  subtype  of  NMES  in  which  stimulation  supports  
functional  and  purposeful  movements  Popovic  et  al  (2001).  This  technique  consists  of  applying  
electrical  currents  to  the  muscles,  making  them  contract  in  a  sequence  that  allows  you  to  perform  
different  tasks.  Some  of  the  examples  are:  holding  a  key,  holding  a  toothbrush,  standing  or  walking  
Vodovnik  et  al  (1978).
C:  video  games
O:  Motor  imagination,  strength,  manual  dexterity.
The  technology  was  developed  in  the  1960s,  during  which  initial  clinical  use  began,  emphasizing  its  
potential  as  an  assistive  device  Hoshimiya  et  al  (1989).  Since  then,  FES  has  evolved  into  an  important  
therapeutic  intervention  that  rehabilitators  can  use  to  help  people  with  diseases  or  injuries  to  the  
nervous  system  regain  their  ability  to  stand,  walk,  reach  and  grasp  Buckett  et  al  (1988) ,  having  
demonstrated  positive  effects  in
Machine Translated by Google

A/A  of  the  President  of  the  Commission
4.-  Material  and  methods
kinesthetic  and  visual,  as  well  as  manual  dexterity  and  strength.
Bioethics  of  the  University  of  Burgos
•  Check  if  there  are  differences  between  FES,  multi-field  FES,  and  virtual  reality  in  terms  of  visual  
motor  imagination,  kinesthetic  and  manual  dexterity.
•  Find  out  if  an  intervention  based  on  the  use  of  virtual  reality  improves  motor  imagination,  both  
kinesthetic  and  visual,  as  well  as  manual  dexterity.
4.1  Type  of  study
Secondary  objectives:
To  carry  out  the  project,  a  collaboration  agreement  will  be  signed  with  the  company  FESIA  
TECHNOLOGY  SL,  which  will  provide  a  FESIA  GRASP  device  for  the  study,  as  well  as  the  
consumables  (electrodes)  necessary  for  the  development  of  the  study.  The  agreement  is  currently  
being  evaluated  by  the  UBU  legal  office.
•  Find  out  if  functional  electrical  stimulation  improves  motor  imagination,  both
It  is  planned  to  register  the  study  on  the  international  platform  Clinicaltrials.gov.
3
•  Check  the  effects  of  FES  and  virtual  reality  regarding  motor  imagination,
A  sample  of  university  students  will  be  divided  into  4  groups,  where  one  of  them  will  act  as  a  control  
group  (without  intervention),  and  the  other  three  will  perform  hand  training  with  two  different  types  of  
FES  devices  (conventional  and  multi-field).  and  a  last  group  will  receive  hands-on  training  with  video  
games.
Intergroup  analyzes  will  be  performed  before  the  start  of  training  (pre-intervention),  after  finishing  the  
program  (post-intervention),  and  three  weeks  after  finishing  (follow-up  evaluation).  Likewise,  intragroup  
analyzes  will  be  carried  out  to  check  whether  the  training  has  caused  an  improvement  in  the  quality  
of  motor  imagination,  as  well  as  an  improvement  in  manual  dexterity  in  each  of  the  groups.
strength  and  manual  dexterity.
2.-  Objectives
3.-  Project  description
4.2.  Description  of  devices
Controlled,  randomized,  parallel  group  clinical  trial.  Unicentric,  and  with  blind  evaluation  by  third  
parties.  Quasi-experimental.
The  present  work  is  a  clinical,  randomized  study  of  parallel  groups  of  a  quasi-experimental  type.
General  objective:
Four  parallel  groups  are  planned.  A  first  group  that  will  have  an  intervention  based  on  multi-field  FES  
with  the  FESIA  GRASP  device;  another  group  that  will  receive  only  FES
Machine Translated by Google

Finally,  Fesia  Grasp  has  a  software  application  on  a  tablet  that  allows,  on  the  one  hand,  to  control  
and  configure  the  stimulation  parameters  and,  on  the  other,  to  monitor  the  evolution  of  the  different  
patients/users  in  an  easy  and  intuitive  way.  The  application  is  FesiaPro,  and  is  designed  to  be  used  
by  healthcare  personnel.
The  three  devices  are  described  below.
The  textile  band  ensures  correct  contact  of  the  electrode  with  the  skin  and,  on  the  other  hand,  serves  
as  a  support  for  both  the  stimulator  and  the  electrode.  The  device  allows  the  generation  of  8  different  
isolated  movements  (flexion  and  extension  of  the  wrist,  thumb,  index  and  fingers  3,  4  and  5).  
Furthermore,  it  is  possible  to  combine  these  movements  with  each  other,  with  the  aim  of  creating  
functional  movements  such  as:  clamp,  lateral  clamp,  palmar  grip,  etc.
VirtualRehab  is  a  therapeutic  physical  rehabilitation  tool  that  uses  reality
with  the  Globus  Elite  electrostimulation  device  (device  with  conventional  electrodes);  a  third  group  
that  will  receive  an  intervention  based  on  virtual  reality;  and  finally  a  control  group,  which  will  not  
receive  any  treatment.
4.2.3.  Description  of  the  VirtualRehab  video  game  for  hand.
The  main  feature  of  this  device  is  its  multi-field  electrode,  which  allows  a  greater  number  of  
movements  to  be  selected,  doing  so  quickly  and  selectively,  and  it  is  also  possible  to  combine  the  
movements  with  each  other.  The  device  is  composed  of  a  stimulator,  a  multi-field  electrode,  a  textile  
band  and  a  software  application.  The  stimulator  generates  electrical  pulses,  which  are  transmitted  to  
the  skin  through  the  multi-field  electrode.  It  is  a  matrix  electrode  designed  to  cover  a  large  part  of  the  
surface  of  the  forearm  and  thus  be  able  to  stimulate  the  muscles  of  the  neuromuscular  groups  of  the  
radial,  ulnar  and  median  nerves.  It  is  composed  of  32  cathodes  (output  fields)  and  8  anodes  (return  
fields),  which  can  be  activated  independently  or  combined,  allowing  it  to  be  adapted  to  the  
anthropometry  of  different  patients.  The  multi-field  electrode  is  personal  and  disposable,  with  an  
estimated  life  of  two  weeks  of  daily  use.
Bioethics  of  the  University  of  Burgos
Among  the  currents  that  can  be  applied  are  the  currents  that  the  Fesia  Grasp  device  also  emits.  
These  are  currents  with  a  biphasic  and  symmetrical  rectangular  pulse  shape,  low  frequencies,  
constant  pulse  widths  and  high  intensities.
The  Fesia  Grasp  device  bases  its  operation  on  superficial  electrical  stimulation  of  the  antebrachial  
muscles  to  provoke  flexion  and  extension  movements  of  the  wrist,  thumb,  index  and  fingers  3,  4  and  
5.  The  device  has  the  CE  marking.
4.2.2.  Description  of  the  Globus  Elite  4-Channel  Electrostimulator  The  
Globus  Elite  4-Channel  Electrostimulator  is  a  traditional  electrical  stimulation  device,  which  allows  up  
to  8  electrodes  to  be  activated  at  the  same  time  (4  channels).  The  device,  which  has  a  CE  marking,  
allows  the  use  of  different  types  of  electrical  currents,  which  are  selected  based  on  the  desired  
therapeutic  objectives  and  the  evolutionary  phase  of  the  person.
A/A  of  the  President  of  the  Commission
4.2.1.  Description  of  the  FESIA  GRASP
4
Machine Translated by Google

A/A  of  the  President  of  the  Commission
b)  Use  a  pacemaker.
The  sample  will  be  randomized  through  a  computer  application  for  assignment  within  one  of  the  
groups  contemplated  in  the  study.
Bioethics  of  the  University  of  Burgos
The  following  inclusion  criteria  are  established:
5
4.3.2.  Inclusion  and  exclusion  criteria
c)  Being  pregnant.
c)  Non-compliance  with  treatment.  Failure  to  complete  sessions  on  schedule
4.3.1.  Type  of  sampling  and  access  to  the  sample
As  exclusion  criteria:
Participation  in  the  study  will  be  proposed  to  students  of  the  Faculty  of  Health  Sciences  of  the  
University  of  Burgos,  so  it  is  a  convenience  sampling.
a)  Severe  medical  problems.
a)  At  your  own  request,  without  giving  reasons.
4.3  Sample
fractures,  etc.
for  each  one.
c)  Intact  skin  (no  breaks,  scratches,  cuts,  and  other  types  of  superficial  or  deep  injuries)  
on  the  arm  where  the  devices  will  be  placed  if  applicable.
The  sample  will  be  composed  mainly,  although  not  exclusively,  of  adults  of  legal  age,  belonging  to  
the  group  of  university  students.
b)  Adverse  events  occur  that  prevent  the  study  from  continuing.
a)  Be  of  legal  age  and  sign  the  informed  consent.
virtual  to  provide  therapy  to  patients  with  neurological  or  musculoskeletal  disorders;  providing  a  wide  
range  of  activities  designed  to  improve  mobility,  coordination  and  strength.  This  tool  is  based  on  the  
idea  of  gamification  in  rehabilitation,  where  patients  participate  in  virtual  games  that  require  physical  
movements  to  complete  challenges.  These  games  adapt  to  the  needs  and  abilities  of  each  patient,  
allowing  personalized  rehabilitation.
e)  Presence  of  other  neuromuscular  pathologies
d)  Peripheral  neuropathies.
b)  Not  suffer  from  any  pathology  in  the  upper  limb  such  as  tendinitis,  edema,
VirtualRehab  allows:  a)  a  comprehensive  evaluation;  b)  personalized  treatment  planning;  c)  monitoring  
and  tracking  patient  progress.  This  tool  has  different  fine  motor  games,  specifically  it  includes  8  video  
games  for  fine  motor  training  that  can  be  customized  for  the  needs  of  each  patient.
Participants  may  leave  the  study  in  the  following  cases:
Machine Translated by Google

MONDAY  TUESDAY  WEDNESDAY  THURSDAY
FRIDAY
PRE  1  Evaluation
Intervention  4
Intervention  1
4.4  Process
WEEK  4
POST  4  Evaluation
The  reason  for  abandonment  will  be  recorded  in  the  database.
It  is  the  longest  phase  of  all  and  extends  over  13  weeks  during  the  months  of  September  to  December  
2023.  Throughout  these  weeks,  pre-intervention  evaluations,  interventions,  as  well  as  post-intervention  
evaluations  will  be  carried  out.  -intervention  and  follow-up  evaluations  two  weeks  after  leaving  the  
intervention.
WEEK  1
SEG  1  Evaluation
As  the  sample  is  obtained,  it  will  be  randomized  and  assigned  to  the  different  groups.
A/A  of  the  President  of  the  Commission
PRE  3  Assessment
6
This  phase  includes  writing  the  project,  obtaining  approval  from  the  ethics  committee  of  the  University  of  
Burgos,  registering  it  on  the  Clinicaltrials.gov  platform,  as  well  as  beginning  to  collect  the  sample.
PRE  2  Evaluation
PRE  4  Assessment
WEEK  5
Intervention  2
There  are  three  phases  of  the  project:  Preparation,  Data  Collection,  and  a  final  Analysis  and  Report  
Preparation.
In  Figure  1  you  can  see  the  distribution  for  each  of  the  weeks.  The  Friday  before  starting  the  intervention,  
the  subjects  will  be  evaluated  (PRE-intervention  Evaluation).  During  the  5  days,  the  corresponding  
interventions  will  be  carried  out  the  following  week,  and  at  the  end  of  the  5th  session  they  will  be  evaluated  
(POST-intervention  Evaluation),  and  two  weeks  later  they  will  be  evaluated  again  in  the  follow-up  evaluation  
(SEG  Evaluation).
A  sample  of  between  20-25  subjects  per  group  is  expected.
WEEK  2
Intervention  3
PRE  5  Assessment
Bioethics  of  the  University  of  Burgos
4.4.2.  Data  collection  phase
POST  2  Evaluation
POST  1  Evaluation
It  will  run  during  the  months  of  June-July  and  the  first  week  of  September  2023.
POST  3  Evaluation
WEEK  3
4.4.1.  Preparation  phase:
Machine Translated by Google

PRE  7  Assessment
PRE  10  Evaluation
POST  evaluation
Intervention  5
POST  8  Evaluation
WEEK  10
The  following  evaluation  tools  are  proposed:
WEEK  9
This  phase  will  take  place  between  the  final  weeks  of  December  2023  and  throughout  January-February  2024.
SEG  5  Evaluation
SEG  2  Evaluation
SEG  9  Evaluation
PRE  8  Evaluation
POST  10  Assessment
WEEK  8
A/A  of  the  President  of  the  Commission
Figure  1.  Timeline  of  the  data  collection  phase.
7
WEEK  12
The  Nine  Hole  Peg  Test  (NHPT)  (Mathiowetz  et  al,  1985)  consists  of  a  manual  test,  in  which  the  subject  must  place  
9  pegs  in  their  corresponding  9  holes,  and  remove  them  again,  the  measured  variable  being  the  time  It  takes  time  to  
complete  the  entire  process.
POST  6  Evaluation
POST  9  Evaluation
WEEK7
SEG  6  Assessment
WEEK  6
Intervention  10
SEG  3  Evaluation
4.5.1.  Nine  Hole  Peg  Test:
4.5.  Evaluation  instruments
PRE  5  Assessment
PRE  9  Assessment
SEG  10  Evaluation
Intervention  9
SEG  8  Evaluation
Intervention  8
4.4.3.  Analysis  and  Reporting
Bioethics  of  the  University  of  Burgos
POST  evaluation
4.5.2.  Box  and  Block:  The  
Box  and  Block  test  is  a  tool  with  standardized  dimensions  and  materials.
SEG  4  Assessment
SEG  7  Evaluation
Intervention  7
WEEK  13
Intervention  6
WEEK  11
This  test  is  included  to  assess  manual  dexterity.
Machine Translated by Google

A/A  of  the  President  of  the  Commission
Chronometry  is  defined  as  the  temporal  congruence  between  an  executed  motor  act  and  the  same  imagined  act.
(Time  executed  motor  act  –  Time  imagined  motor  act)
Bioethics  of  the  University  of  Burgos
In  this  case,  the  NHPT  itself  is  proposed  as  the  motor  act  executed.  So  once  administered  to  obtain  the  test's  own  
variable  (time  taken  to  perform),  the  participant  will  be  asked  to  imagine  performing  the  test,  and  it  will  be  timed.  Both  
measurements  will  be  taken  in  seconds,  to  calculate  the  chronometric  ratio,  according  to  the  formula  (Liepert,  2012):
4.5.2  Chronometry:
The  administration  manual  specifies  that  the  visual  and  kinesthetic  items  will  not  be  administered  consecutively,  but  
rather  are  altered  randomly  to  avoid  bias.
The  evaluation  of  motor  imagination  capacity  requires  at  least  two  tests.
8
4.5.3.  Movement  imagery  Questionnaire,  revised  (MIQ-RS)
4.5.3  Jamar  hand  dynamometer
The  MIQ-RS  questionnaire  (Gregg  et  al,  2010)  consists  of  2  subscales,  one  visual  and  the  other  kinesthetic,  with  7  
items  each,  with  each  item  scored  on  a  7-point  Likert  scale  (the  higher  the  score,  the  higher  the  score).  ease  to  
imagine).  For  all  items,  the  user  is  asked  to  perform  a  specific  motor  act  (only  once),  return  to  the  starting  position,  and  
then  imagine  it.  When  scoring  the  visual  scale,  the  participant  is  asked  to  generate  an  image  “as  if  it  were  seen”  by  
making  the  gesture,  while  the  kinesthetic  scale  is  asked  to  “remember  the  sensation  of  the  movement.”
The  Jamar  hand  dynamometer  is  used  to  measure  grip  strength  in  the  hand,  it  allows  the  force  exerted  by  the  individual  
to  be  converted  into  a  numerical  reading.  The  subject  is  asked  to  grasp  the  device  and  is  instructed  to  perform  the  
maximum  sustained  contraction.  The  force  is  recorded  in  kilograms.
It  is  specified  that  the  subject  must  sit  in  front  of  a  rectangular  box  with  his  hands  next  to  it.  This  box  is  made  of  wood  
with  a  base  53.7  cm  wide  and  25.4  cm  long;  This  is  divided  into  two  square  compartments  with  a  side  of  25.4  cm  each,  
separated  from  each  other  by  a  15.2  cm  high  divider;  Both  compartments  are  padded  in  order  to  reduce  noise  during  
testing.  The  test  contains  150  cubic-shaped  wooden  blocks  measuring  2.5  cm  on  each  side.  The  number  of  blocks  that  
the  subject  has  transported  from  one  compartment  to  another  with  each  hand  in  one  minute  of  time  must  be  recorded.
Time  motor  act  performed
Rc  =
Higher  scores  indicate  better  manipulative  skill.
Machine Translated by Google

A/A  of  the  President  of  the  Commission
Startup  (5  minutes):  Place  the  device  and  verify  that  the  previous  configuration  
is  correct.
4.6.2  FESIA  GRASP  Group:
Bioethics  of  the  University  of  Burgos
Protocol  1:  Training:  It  will  be  
used  during  the  first  half  of  the  first  session  so  that  the  participant  becomes  accustomed  to  the  
sensation  of  electrical  stimulation  through  an  automatic  sweep  of
There  will  be  5  30-minute  sessions,  and  the  2  available  protocols  will  be  used:  training  and  grip.
•  First  part  (5  minutes):  selective  contractions  of  the  different  groups
Each  group  will  receive  a  total  of  5  sessions  (Figure  1).  Next,  it  is  explained  what  each  of  the  4  groups  
will  do.
•  Weeks  4-5:  training  in  activities  of  daily  living  with  the  help  of  FES
4.6.1  Control  group:  This  group  will  not  receive  any  type  of  intervention  and  will  continue  with  their  
usual  routine.  A  commitment  will  be  requested  that  they  do  not  begin  any  physical  activity  other  than  
that  previously  carried  out  for  the  duration  of  the  study.
The  general  development  proposed  during  sessions  1-3  is  as  follows:
9
It  will  be  used  in  sessions  1-5,  both  inclusive.  Firstly,  the  device  configuration  will  be  
carried  out,  selecting  the  combinations  of  cathodes  that  generate  clearer  flexion  and  extension  
movements  of  the  wrist,  thumb,  index  and  fingers  3,  4  and  5.  If  the  motor  threshold  is  not  found  
in  any  user  for  any  of  the  movements,  or  it  is  considered  that  it  may  be  harmful  or  not  
beneficial  to  stimulate  any  of  these,  it  will  not  be  selected.  It  will  be  important  to  do  this  setup  
thoroughly  in  the  first  session,  and  minor  variations  will  be  made  in  subsequent  sessions.  
Next,  the  therapy  will  begin.  This  will  progress  as  follows  (it  will  be  adjusted  depending  
on  the  patients'  progress):
4.6.  Description  of  the  intervention.
•  Sessions  1-3:  selective  contractions  of  the  forearm  muscle  groups.
As  explained,  the  study  will  consist  of  4  groups.
The  minimum  values  are  14,  and  the  maximum  values  are  98  (minimum  7  and  maximum  49  for  the  
subscales).
electrical  stimulation.
muscles  through  FES.
•
Protocol  2:  Grip
This  MIQ-RS  version  was  made  to  be  administered  to  a  population  with  some  type  of  physical  
disability,  but  it  can  also  be  applicable  to  healthy  people.  The  Spanish  version  of  the  MIQ-RS  has  
been  validated  by  Cantalejo-Fernández  (2022)  in  a  sample  of  university  students,  obtaining  
Cronbach's  Alpha  values  of  0.90  and  a  two-factor  structure.
•  Second  part  (10-15  minutes):  voluntary  selective  contractions  by  the
Machine Translated by Google

A/A  of  the  President  of  the  Commission
The  general  development  proposed  during  sessions  1-3  is  as  follows:
previously  activated  in  functional  actions  through  FES:  grasping  objects  of  different  sizes.
from  Fesia,  both  in  the  training  protocol  and  in  the  grip  protocol:  25  Hz  frequency,  250  us  
pulse  width.  The  intensity  will  be  5  mA  above  the  motor  threshold,  the  motor  threshold  being  the  
minimum  intensity  at  which  the  movement  of  the  limb  is  perceived  visually.  If  the  patient  cannot  
tolerate  such  intensity,  he  will  limit  himself  to  the  maximum  intensity  at  which  this  sensation  
is  pleasant.
Bioethics  of  the  University  of  Burgos
The  selected  electro-parameters  will  be  those  preconfigured  by  default  in  the  systems
Startup  (5  minutes):  Place  the  device  and  verify  that  the  configuration  is  
correct.
•  Startup  (5  minutes):  Place  the  device  and  verify  that  the  •  configuration  is  
correct.
muscles  through  FES.
forearm.
•  Second  part  (10-15  minutes):  inclusion  of  functional  movements
•  Weeks  4-5:  training  in  activities  of  daily  living  with  the  help  of  FES
•  Second  part  (10-15  minutes):  general  voluntary  contractions  by  the  patient,  guided  by  the  
therapist.
You  will  also  carry  out  5  sessions  of  30  minutes  duration.  The  device  will  be  applied  in  the  following  
way  (it  will  be  adjusted  depending  on  the  patients'  progress):
•  Startup  (5  minutes):  placing  the  device  and  verifying  that  the  previous  
configuration  is  correct.
10
•  Sessions  1-3:  general  repetitive  contractions  of  the  muscle  groups  of  the
•  First  part  (5  minutes):  selective  contractions  of  the  different  groups
The  general  development  proposed  during  sessions  4-5  is  as  follows:
patient,  guided  by  the  therapist.
Therapy  times  will  vary  depending  on  the  patient's  fatigue  measured  using  a  Borg  scale.  The  
score  for  this  should  not  exceed  3  points  out  of  10  (<  =  3/10),  1  minute  after  the  end  of  the  exercise.  
If  the  perception  of  fatigue  is  greater,  first  the  intensity  (eg  frequency  of  movements)  and  then  
the  duration  of  the  therapy  will  be  adjusted.
•  First  part  (5  minutes):  general  contractions  of  the  different  groups
•
4.6.3.  Globus  Elite  Electrostimulator  Group:
The  general  development  proposed  during  sessions  4-5  is  as  follows:
muscles  through  FES.
Machine Translated by Google

A/A  of  the  President  of  the  Commission
registered.
4.6.4.  Rehab  Hands  Virtual  Group
Bioethics  of  the  University  of  Burgos
The  session  will  be  divided  into  three  phases:  warm-up,  effort  and  return  to  calm.
The  group  will  play  for  5  30-minute  sessions.  The  Virtual  Rehab  Hands  device  includes  fine  motor  
games  thanks  to  an  ergonomic  support  to  rest  the  arm  and  be  able  to  perform  the  exercises  more  
comfortably  with  the  Leap  Motion®  sensor  that  accurately  detects  the  movements  of  the  hands,  
fingers  and  wrists.
Every  effort  will  be  made  to  remain  alert  to  potential  complications  and  unexpected  results.  If  
complications  occur,  the  first  concern  will  be  the  safety  of  the  participant.
The  electro-parameters  selected  will  be  the  same  as  those  used  in  the  previous  group.
4.7.  List  of  expected  adverse  events
Therapy  times  will  vary  depending  on  the  patient's  fatigue  measured  using  a  Borg  scale.  The  
score  for  this  should  not  exceed  3  points  out  of  10  (<  =  3/10),  1  minute  after  the  end  of  the  exercise.  
If  the  perception  of  fatigue  is  greater,  first  the  intensity  (eg  frequency  of  movements)  and  then  
the  duration  of  the  therapy  will  be  adjusted.
During  the  course  of  the  proposed  study,  all  adverse  effects  will  be
eleven
•  Second  part  (10-15  minutes):  inclusion  of  functional  movements
•  In  the  phase  of  returning  to  bed:  “flexion-extension  frog”;  “flexion  and  extension  bird
“wrist”.
previously  activated  in  functional  actions  through  FES:  grasping  objects  of  different  sizes.
•  First  part  (5  minutes):  general  contractions  of  the  different  groups
•  In  the  warm-up  phase,  “wrist  flexion  and  extension  bird”  will  be  played;  “candy  flexion  and  
extension”;  “ulnar-radial  deviation  frog”
below)  that  will  be  minimized  by  taking  their  respective  precautionary  measures:
Intensive  use  of  the  Fesia  Grasp  product  may  entail  a  series  of  risks  (described
•  In  the  effort  phase:  “digital  piano”;  “balloon  clamps”;  “finger  abduction”
muscles  through  FES.
•  Electrical  stimulation  may  cause  an  uncomfortable  sensation  or  very  mild  pain  in  the  first  
few  uses  until  you  become  familiar  with  the  sensation.
Machine Translated by Google

A/A  of  the  President  of  the  Commission
•  You  have  swelling  of  the  leg,  knee,  ankle  or  foot.
Bioethics  of  the  University  of  Burgos
In  this  study,  clinical  research  is  carried  out  with  health  products  on  people.
5.-  Proposal  from  the  researchers  to  ensure  compliance  with  legal  and  ethical  aspects  of  the  
research  and  the  rights  of  the  participants
•  Presents  blisters  or  sores  in  the  stimulation  application  area.
6.-  Determination  of  the  potential  benefits  and  risks  of  the  study
•  You  feel  cardiac  stress  or  tachycardia  during  pacing.
12
The  patient  must  immediately  stop  using  the  device  in  the  following  cases:
Compliance  with  Organic  Law  3/2018,  of  December  5,  on  the  Protection  of  Personal  Data  and  
guarantee  of  digital  rights,  will  be  ensured.
The  privacy  of  the  participants  will  be  protected  and  the  exclusive  use  of  the  data  collected  for  the  
purposes  of  the  project  and  those  studies  that  may  result  from  it  will  be  guaranteed.
•  You  have  redness  or  irritation  in  the  stimulation  application  area  for  more  than  one  hour  
after  removing  the  electrode.
•  It  is  normal  for  the  area  where  the  stimulation  has  been  applied  to  appear  red  after  
removing  the  device;  this  redness  should  disappear  in  approximately  one  hour.
In  order  to  safeguard  the  integrity,  well-being  and  right  to  privacy  of  the  participating  subjects,  the  
study  is  carried  out  following  the  standards  dictated  by  the  Declaration  of  Helsinki  of  the  World  
Medical  Assembly  (64th  General  Assembly,  Fortaleza,  Brazil,  October  2013). ,  the  Council  of  Europe  
Convention  on  human  rights  and  biomedicine,  the  Standards  of  Good  Clinical  Practice,  Royal  Decree  
1090/2015,  of  December  4,  which  regulates  clinical  trials  with  medicines,  the  Ethics  Committees  of  
Research  with  medicines  and  the  Spanish  Registry  of  Clinical  Studies  and  Royal  Decree  1591/2009,  
of  October  16,  which  regulates  health  products.
Before  the  beginning  of  the  study,  explicit  informed  consent  will  be  requested  from  participants,  
through  an  online  form  in  which  the  objectives  and  what  their  participation  consists  of  will  be  explained  
(Annex  1).
•  In  some  cases,  electrical  stimulation  or  contact  of  the  gel  with  the  skin  could  cause  an  
allergic  reaction  or  irritation  at  the  contact  surface.
Machine Translated by Google

A/A  of  the  President  of  the  Commission
All  participants  will  be  sent  an  information  document  and  a
•  There  is  redness  or  irritation  in  the  stimulation  application  area  during
•  Presents  blisters  or  sores  in  the  stimulation  application  area.
Bioethics  of  the  University  of  Burgos
more  than  one  hour  after  removing  the  electrode.
informed  consent,  where  the  entire  study  that  is  going  to  be  carried  out  and  what  data  will  be  used  
will  be  explained  to  them.  It  is  attached  as  annex  1.
•  In  some  cases,  electrical  stimulation  or  contact  of  the  gel  with  the  skin  could  cause  an  allergic  
reaction  or  irritation  at  the  contact  surface.
The  benefits  that  the  subject  obtains  in  this  project  are  the  motor  improvement  and  functionality  of  
the  upper  limb,  as  well  as  a  direct  contribution  to  the  advancement  of  knowledge  of  new  techniques  
or  therapies  for  their  pathology.
The  patient  must  immediately  stop  using  the  device  in  the  following  cases:
7.-  Information  and  informed  consent  document,  if  applicable
The  device  is  sufficiently  safe,  the  sample  corresponds  to  healthy  subjects,  and  no
•  Presents  swelling  in  the  extremity.
•  Electrical  stimulation  may  cause  an  uncomfortable  sensation  or  very  mild  pain  in  the  first  few  
uses  until  you  become  familiar  with  the  sensation.
Regarding  the  collection  of  data  on  motor  function,  this  is  carried  out  using  non-invasive  techniques  
so  they  do  not  pose  any  risk  to  the  participant.
•  It  is  normal  for  the  area  where  the  stimulation  has  been  applied  to  appear  red  after  removing  
the  device;  this  redness  should  disappear  in  approximately  one  hour.
13
The  participation  of  the  subjects  in  this  project  implies  the  eventual  possibility  of  suffering  adverse  
effects,  none  of  which  seriously  compromise  the  integrity  of  the  subject.  Every  effort  will  be  made  to  
remain  alert  to  potential  complications  and  unexpected  results.  If  complications  occur,  the  first  
concern  will  be  patient  safety.
•  You  feel  a  significant  increase  in  muscle  spasticity.
Not  applicable.
8.-  Compensation  provisions  for  participants,  if  applicable
•  You  feel  cardiac  stress  or  tachycardia  during  pacing.
The  intensive  use  of  FES  can  entail  a  series  of  risks  (described  below)  that  will  be  minimized  by  
taking  their  respective  precautionary  measures:
9.-  Coverage  in  case  of  damage  due  to  participation,  if  applicable
Machine Translated by Google

A/A  of  the  President  of  the  Commission
Hoshimiya  N.  A  master-slave  type  multichannel  functional  electrical  stimulation  (FES)  system  for  the  
control  of  the  paralyzed  upper  extremities.  Automedia.  1989;11:209-20.
Bélanger,  M.,  Stein,  RB.,  Wheeler,  GD.,  Gordon,  t.  and  Leduc,  B.  (2000).  Electrical  stimulation:  Can  
it  increase  muscle  strength  and  reverse  osteopenia  in  spinal  cord  injured  individuals?
Bioethics  of  the  University  of  Burgos
https://doi.org/10.1053/apmr.
Archives  of  1090-1098.
Liepert  J,  Greiner  J,  Nedelko  V,  Dettmers  C.  (2012).  Reduced  upper  limb  sensation  impairs  mental  
chronometry  for  motor  imagery  after  stroke:  Clinical  and  electrophysiological  findings.
11.-  Bibliography
Cantalejo-Fernández  M,  Díaz-Arribas  MJ,  Fernández-de-Las-Peñas  C,  Plaza-Manzano  G,  Ríos-León  
M,  Martín-Casas  P.  (2022).  Translation  and  Validation  of  the  Spanish  Movement  Imagery  
Questionnaire  Revised  Second  Version  (MIQ-RS).  PM&R.14(1),68-76.  doi:  https://doi.org/10.1002/
pmrj.12546
Al-Saegh,  A.,  Dawwd,  S.A.,  and  Abdul-Jabbar,  J.M.  (2021).  Deep  learning  for  EEG-based  classification  
of  motor  imagery:  A  review.  Control  and  processing  of,  102172,  https://doi.org/10.1016/
j.bspc.2020.102172  biomedical  signals  63
Fesia  Grasp  –  Lyncare.  (sf).  (June  15,  2023).  Hand  Function  Rehabilitation  https://
www.lyncare.ie/fesia-grasp-7  Gregg  
M,  Hall  C,  Butler  A.  The  MIQ-RS:  A  Suitable  Option  for  Examining  Movement  Imagery  Ability.  (2010).  
Evidence  Based  Complement  Alternative  Medicine.7(2),  249-57.  doi:  https://doi.org/10.1093/ecam/
nem170.
The  characteristics  between  groups  will  be  analyzed  before  the  start  to  confirm  that  there  are  no  
differences  between  them  before  the  start  of  the  intervention.
81(8),
Physical  Medicine  and  Rehabilitation,
Subsequently,  intra-group  analysis  will  be  done  to  see  the  effects  on  each  of  them,  as  well  as  inter-
group  analysis  to  see  if  there  are  differences  between  the  different  interventions.  These  intra-group  
and  inter-group  analyzes  will  be  done  with  respect  to  the  baseline  and  follow-up  measurement.
Buckett  JR,  Peckham  PH,  Thrope  GB,  Braswell  SD,  Keith  MW.  A  flexible,  portable  system  for  
neuromuscular  stimulation  in  the  paralyzed  upper  extremity.  IEEE  Trans  Bio-Med  Eng.  
1988;35:897-904,  https://doi.org/10.1109/10.8669
contemplates  the  possibility  of  generating  any  type  of  damage.
Maleševiÿ  J,  Štrbac  M,  Isakoviÿ  M,  Kojiÿ  V,  Konstantinoviÿ  L,  Vidakoviÿ  A,  Dedijer  Dujoviÿ  S,  Kostiÿ  
M,  Keller  T.  Temporal  and  Spatial  Variability  of  Surface  Motor  Activation  Zones  in
Neurorehabilitation  Neural  Repair.  26(5),470–8.
,
10.-  Description  of  the  data  analysis  and  the  statistical  study  required,  if  applicable
14
Machine Translated by Google

1  To  cover  this  section,  it  is  recommended  to  read  the  FAQ_Guide  document  beforehand.
A/A  of  the  President  of  the  Commission
The  data  is  not  considered  to  belong  to  any  special  data  characteristic.
400.  https://doi.org/10.3233/nre-2011-0717
Bioethics  of  the  University  of  Burgos
https://doi.org/10.1016/j.neulet.2004.07.053.
Shenton,  JT.,  Schwoebel,  J.,  and  Coslett,  HB.  (2004)  Mental  motor  imagery  and  the  body  schema:  
evidence  for  proprioceptive  dominance.  Neuroscience  Letters.  370  (1),19-24,
McCormick,  K.,  Zalucki,  N.,  Hudson,  ML.,  and  Moseley,  GL.  (2007).  Faulty  proprioceptive  information  
disrupts  motor  imagery:  an  experimental  study.  Australian  Journal  of  Physiotherapy,  53  (1)  41-45,  
https://doi.org/10.1016/S0004-9514(07)70060-0.
Basic  identification  and  social  data  will  be  collected  that  will  be  used  to  describe  the  sample,  according  
to  the  principle  of  minimization,  and  own  data  derived  from  the  tests  administered  will  be  collected.
Popovic  MR,  Keller  T,  Papas  IPI,  Dietz  V,  Morari  M.  Surface-stimulation  technology  for  grasping  and  
walking  neuroprostheses.  IEEE  Eng  Med  Biol  Mag  2001;20:82-93.  https://doi.org/10.1109/51.897831  
Sabut,  S.K.  et  al.  (2011).  Functional  
Electrical  Stimulation  of  Dorsiflexor  Muscle:  Effects  on  Dorsiflexor  Strength,  Plantar  flexor  Spasticity,  
and  Motor  Recovery  in  Stroke  Patients':  393  –
12.2.-  If  they  are  special  categories  of  data  (health,  biometric,  genetic...).  Indicate  which  category  
they  belong  to.
Martín-Odriozola,  A.,  Rodríguez-de-Pablo,  C.,  &  Zabaleta-Rekondo,  H.  (2021).  Hand  dexterity  
rehabilitation  using  selective  functional  electrical  stimulation  in  a  person  with  stroke.  BMJ  Case  Reports  
CP,  14(8),  e242807,  http://dx.doi.org/10.1136/bcr-2021-242807
12.-  In  the  event  that  the  research  project  involves  the  processing  of  personal  data,  complete  
the  following  sections1
12.1.-  Type  of  personal  data  that  will  be  processed  (identification,  social,  academic,  professional,  
economic  and  financial...)
Mathiowetz  V,  Weber  K,  Kashman  N,  et  al.  (1985).  Adult  norms  for  the  Nine  Hole  Peg  Test  of  finger  
dexterity.  OTJR:  Occupation,  Participation  and  Health.  5:24–38.
Hemiplegic  Patients  During  Functional  Electrical  Stimulation  Therapy  Sessions.  Artif  Organs.
Stein  RB,  Peckham  PH,  Popoviÿ  DB.  Neural  prostheses:  replacing  motor  function  after  disease  or  
disability.  1st  ed.  Oxford:  Oxford  University  Press;  1992.
fifteen
Researcher  (link)
Vodovnik  L,  Kralj  A,  Stanic  U,  Acimovic  R,  Gros  N.  Recent  applications  of  functional  electrical  
stimulation  to  stroke  patients  in  Ljubljana.  Clin  Orthop  Relat  Res.  1978;131:64-70  https://doi.org/
10.1097/00003086-197803000-00009
2017  Nov;41(11):E166-E177,  https://  doi:  10.1111/aor.13057.  PMID:  29148131.
Machine Translated by Google

A/A  of  the  President  of  the  Commission
12.7.-  If  applicable,  indicate  if  several  organizations  or  partners  participate  in  the  project.
12.6.-  In  case  of  anonymization  or  pseudonymization,  indicate  the  techniques  used.
-  The  researchers  will  only  have  access  to  the  personal  data  of  the  participants  in  the  informed  
consent  document.  The  signed  document  will  be  a  paper  file,  which  will  be  kept  in  a  
locked  cabinet  within  the  UBU  facilities.
Bioethics  of  the  University  of  Burgos
The  data  will  be  dissociated  to  the  extent  possible.
A  collaboration  agreement  will  be  signed  with  the  company  FESIA  TECHNOLOGY  SL,  for  the  transfer  
of  the  FESIA  GRASP  device.
12.5.-  Indicate  whether  the  data  are  going  to  be  anonymized  (it  is  not  possible  to  identify  the  
persons)  or  pseudo-anonymized  (a  non-identifying  or  identifiable  code  is  assigned  to  each  
subject,  so  that  subsequent  identification  would  be  possible).
It  will  be  composed  of  the  first  letter  of  the  first  name  and  the  last  of  the  surnames.  This  
will  be  followed  by  a  hyphen  and  the  figure  resulting  from  adding  the  day  and  month  of  data  
collection.  For  example,  if  the  interviewer's  name  is  Montserrat  Santamaría  Vázquez,  and  
she  conducted  the  interview  on  May  12,  her  code  will  be:  MAZ-17
The  data  will  be  pseudonymised.  A  non-identifying,  non-identifiable  code  is  assigned  to  each  subject,  
so  that  subsequent  identification  would  be  possible.
-
-  Data  from  the  pre/post  intervention  and  follow-up  interviews  will  be  included  in  Excel,  
where  each  participant  will  be  assigned  an  anonymous  participation  code  that  
allows  the  linking  of  pre-post  intervention  and  follow-up  results.
12.4.-  Indicate  how  the  data  will  be  collected  (interviews,  surveys,  forms,  Internet,  etc.).
The  anonymous  participation  code  will  not  allow  the  identification  of  participants:
The  data  will  be  collected  through  a  clinical  interview  and  the  administration  of  the  tests  in  person.
12.3.-  Indicate  the  group  from  which  the  data  is  collected  (adults,  children  under  14  years  of  
age,  people  with  illness,  functional  diversity  or  physical/mental  disability.
-  Once  the  project  has  started,  only  the  main  researcher  will  have  access  to  the  identifying  data  
of  the  participants.
16
-  The  data  collected  in  the  interviews  and  test  administration  will  be  transferred  to  an  Excel  
document,  to  which  only  the  project  researchers  will  have  access.
Adults.  University  students.
Machine Translated by Google

A/A  of  the  President  of  the  Commission
12.11.-  Will  data  be  communicated  or  transferred  to  third  parties?
12.9.-  Indicate  if  the  purpose  of  the  treatment  is:
Bioethics  of  the  University  of  Burgos
ÿ  Process  data  on  a  large  scale.
from  the  day  of  signing  the  informed  consent.  For  example,  if  your  name  is  Montserrat  
Santamaría  Vázquez,  and  you  conducted  the  interview  on  May  12,  your  code  will  be:  MAZ-17
ÿ  Create  personal  profiles.
If  a  scientific  publication  were  derived  from  the  work  carried  out,  the  database  (without  the  possibility  of  
identifying  the  subject)  would  be  shared  in  open  access  databases,  in  addition  to  presenting  the  
possible  results  in  the  content  of  the  article.
-  Each  participant  will  be  given  a  non-identifiable  code,  with  the  following
Office  365)  from  the  University  of  Burgos;  Therefore,  the  information  will  be  hosted  in  the
12.10.-  Is  the  international  transfer  of  data  outside  the  European  Union  foreseen?
17
servers  of  said  University.
No.
Some  of  these  measures  have  already  been  mentioned  in  previous  sections.  Next,
three  subsequent  years  in  order  to  ensure  the  processing  of  data  for  exclusive  purposes
ÿUse  technologies  that  may  be  especially  intrusive,  electronic  surveillance,  data  mining,  
biometrics,  genetic  techniques,  geolocation.
formula:  The  anonymous  participation  code  will  not  allow  the  identification  of  the  
participants:  it  will  be  composed  of  the  first  letter  of  the  first  name  and  the  last  of  the  
surnames.  This  will  be  followed  by  a  dash  and  the  figure  resulting  from  adding  the  day  and  month
ÿYou  process  data  related  to  the  observation  of  public  access  areas.
research.  The  storage  location  for  the  information  will  be  One  Drive  (package  of
they  appear  again  collected:
12.8.-  Duration  of  data  processing.  Period  of  conservation/deletion  of  data  at  the  conclusion  of  
the  investigation  and  place  of  conservation.
ÿTreat  special  categories  of  data.
No.  It  is  not  planned  to  contact  the  subjects  again  once  this  project  ends.
12.12.-  Is  the  reuse  of  personal  data  for  research  purposes  planned?
X  ÿ  Monitoring,  control  and  observation  of  people  (monitoring).
The  databases  will  be  kept  throughout  the  life  of  the  project  and  at  least  during  the
12.13.-  Briefly  indicate  the  technical  and  organizational  measures  that  will  be  taken  with  respect  
to  data  processing  (pseudonymization,  access  control  and  registration,  data  encryption  or  
coding...).
Machine Translated by Google

Bioethics  of  the  University  of  Burgos
12.14.-  Indicate  other  aspects  that  you  consider  relevant  regarding  data  protection.
The  favorable  report  from  the  Bioethics  Commission  of  the  University  of  Burgos  to  carry  out  the  
previously  referenced  project.
-  Informed  consents,  where  identifying  data  appear,  are
Burgos  on  June  26,  2023.
Participation  will  be  free  and  there  will  be  no  type  of  benefit  to  participants.
They  will  be  kept  under  lock  and  key,  in  paper  format,  in  the  facilities  of  the  Faculty  of  
Health  Sciences,  and  only  the  principal  investigator  will  have  access.
Signed:  Montserrat  Santamaría  Vázquez
Contact  information  for  the  person  responsible  will  be  provided  to  clarify  any  doubts  that  may  arise  
regarding  the  process.
-  Digital  files  derived  from  research,  such  as  databases  and
A/A  of  the  President  of  the  Commission
REQUEST:
others  will  be  hosted  on  the  OneDrive  Platform  (Office  365),  with  limited  access  to  project  
researchers.
18
Machine Translated by Google

Our  intention  is  that  you  receive  correct  and  sufficient  information  so  that  you  can
VOLUNTARY  PARTICIPATION
evaluate  and  judge  whether  or  not  you  want  to  participate  in  this  study.  To  do  this,  read  this  
information  sheet  carefully.  We  will  inform  you  and  clarify  any  doubts  that  may  arise  after  the  
researcher's  explanation.  In  addition,  you  can  consult  with  the  people  you  consider  
appropriate.
INTRODUCTION
STUDY  DESCRIPTION
We  are  writing  to  you  to  invite  you  to  participate  in  the  study  “Improvement  of  motor  
imagination  capacity  and  manual  dexterity  through  functional  electrical  stimulation”,  which  
has  been  approved  by  a  Bioethics  Committee  of  the  University  of  Burgos.  The  promoter  of  
the  study  is  the  University  of  Burgos  and  it  is  a  study  with  a  low  level  of  intervention  (BNI)  
since  it  uses  techniques  widely  used  in  the  usual  practice  of  numerous  centers  for  many  
years.
The  project  is  a  clinical  study  with  a  medical  product  within  the  framework  of  collaboration  
between  the  University  of  Burgos  (UBU)  and  Fesia  Technology.  The  objective  of  this  study  
is  to  verify  the  effects  of  functional  electrical  stimulation  and  virtual  reality  on  motor  
imagination,  strength  and  manual  dexterity.  The  study  will  be  carried  out  following  the  
following  methodology:
PRINCIPAL  INVESTIGATOR:  Dr.  Montserrat  Santamaría  Vázquez
THE  PURPOSE  OF  THE  STUDY
To  check  the  effects  of  functional  electrical  stimulation  (FES)  and  virtual  reality  regarding  
motor  imagination,  strength  and  manual  dexterity.
CONTACT  PHONE:  630  56  98  20.  EMAIL:  msvazquez@ubu.es
PARTICIPANT  INFORMATION  SHEET
You  should  know  that  your  participation  in  this  study  is  voluntary  and  that  you  can  decide  not  
to  participate  or  change  your  decision  and  withdraw  your  consent  at  any  time,  without  altering  
your  relationship  with  your  academic  staff  or  causing  any  harm  to  the  treatment  you  receive.  
gives.
If  you  decide  to  abandon  the  study,  you  can  do  so  by  allowing  the  use  of  the  data  obtained  
so  far  or,  if  you  wish,  your  data  will  be  deleted  from  the  computer  files.  You  may  also  be  
withdrawn  from  the  study  if  at  any  time  any  type  of  intolerance  or  discomfort  related  to  the  
intervention  is  detected.
PROJECT  TITLE:  Improvement  of  motor  imagination  capacity  and  manual  dexterity  through  
functional  electrical  stimulation
A/A  of  the  President  of  the  Commission
Bioethics  of  the  University  of  Burgos
19
Machine Translated by Google

-  Olalla  Saiz  Vázquez.
dolls.
The  type  of  intervention  you  will  receive  is  assigned  at  random,  that  is,  neither  you  nor  the  researchers  
who  evaluate  you  will  know  which  group  you  belong  to.  This  procedure  is  very  necessary  for  the  
results  of  the  study  to  be  valid.
At  the  end  of  the  intervention,  the  clinical  examination  will  be  repeated.  These  assessments  will  be  
repeated  2  weeks  after  completing  the  intervention.
-  Aitor  Martín  Odriozola.
•  Group  3:  Five  30-minute  sessions  of  electrical  stimulation  will  be  performed  on  the  forearm  
muscles  using  general  movements  provided  by  the  4-channel  Globus  Elite  device.
-  Montserrat  Santamaría  Vázquez.
•  Group  4:  The  group  will  play  for  5  sessions  of  30  minutes.  The  Virtual  Rehab  Hands  device  
includes  fine  motor  games  thanks  to  an  ergonomic  support  to  rest  the  arm  and  be  able  to  
perform  the  exercises  more  comfortably  with  the  Leap  Motion®  sensor  that  accurately  detects  
the  movements  of  the  hands,  fingers  and
-  Juan  Hilario  Ortiz  Huerta.
If  modifications  are  necessary  throughout  the  study,  you  will  be  notified  in  advance.
•  Group  1:  This  group  will  not  receive  any  type  of  intervention  and  will  continue  with  their  usual  
routine.  A  commitment  will  be  requested  that  they  do  not  begin  any  physical  activity  other  
than  that  previously  carried  out,  for  the  duration  of  the  study.
The  research  team  that  will  access  your  data  on  behalf  of  the  person  responsible  for  the  file  is  made  
up  of:
•  Group  2:  Five  30-minute  sessions  of  electrical  stimulation  will  be  performed  on  the  forearm  
muscles  using  selective  movements  provided  by  the  Fesia  Grasp  device.
The  planned  duration  of  the  study  is  1  week  and  a  total  of  between  80  and  100  people  will  be  recruited.  
On  the  first  day,  an  initial  physical  evaluation  will  be  performed  to  assess  the  motor  and  functional  
status  of  the  upper  limb.
An  average  of  5  application  sessions  will  be  applied  using  electrical  stimulation,  virtual  reality  in  your  
upper  extremity.  These  sessions  will  be  done  5  times  a  week  for  1  week.  If  you  belong  to  the  control  
group,  no  technique  will  be  applied.  In  addition,  assessments  of  hand  function  will  be  carried  out  
before,  after  and  after  2  weeks  of  the  protocol.
It  is  important  to  emphasize  that  you  will  not  receive  any  type  of  drug  during  your  participation.
You  will  be  randomly  assigned  to  one  of  the  4  groups  in  this  study:
A/A  of  the  President  of  the  Commission
Bioethics  of  the  University  of  Burgos
twenty
Machine Translated by Google

•  Presents  blisters  or  sores  in  the  stimulation  application  area.
BENEFITS,  RISKS  AND  DISCOMFORT  ARISING  FROM  YOUR  PARTICIPATION
Given  the  characteristics  of  the  study  and  since  it  is  not  a  drug  study,  the  risks  are  minimal.  
The  intensive  use  of  FES  can  entail  a  series  of  risks  (described  below)  that  will  be  minimized  
by  taking  their  respective  precautionary  measures:
You  are  not  expected  to  receive  any  financial  compensation  from  this  study.
•  You  feel  a  significant  increase  in  muscle  spasticity.
FREE  WITHDRAWAL
•  There  is  redness  or  irritation  in  the  stimulation  application  area  during
You  have  the  right  to  withdraw  or  revoke  consent  at  any  time,  without  giving  reasons  and  
without  affecting  your  current  or  future  relationship  with  your  University,  or  your  legal  rights.  
And  also  that,  consequently,  no  new  data  will  be  collected,  although  the  information  recorded  
up  to  that  point  cannot  be  deleted.
more  than  one  hour  after  removing  the  electrode.
CONFIDENTIALITY  AND  USE  OF  DATA
It  is  important  to  emphasize  that  you  will  not  receive  any  type  of  drug  during  your  participation.
•  In  some  cases,  electrical  stimulation  or  contact  of  the  gel  with  the  skin  could  cause  an  
allergic  reaction  or  irritation  at  the  contact  surface.
The  patient  must  immediately  stop  using  the  device  in  the  following  cases:
If  modifications  are  necessary  throughout  the  study,  you  will  be  notified  in  advance.
WHAT  YOUR  PARTICIPATION  CONSISTS  OF
•  Electrical  stimulation  may  cause  an  uncomfortable  sensation  or  very  mild  pain  in  the  first  
few  uses  until  you  become  familiar  with  the  sensation.
•  Presents  swelling  in  the  extremity.
•  You  feel  cardiac  stress  or  tachycardia  during  pacing.
•  It  is  normal  for  the  area  where  the  stimulation  has  been  applied  to  appear  red  after  
removing  the  device;  this  redness  should  disappear  in  approximately  one  hour.
An  average  of  5  application  sessions  will  be  applied  using  electrical  stimulation,  virtual  reality  
in  your  upper  extremity.  These  sessions  will  be  done  5  times  a  week  for  1  week.  If  you  belong  
to  the  control  group,  no  technique  will  be  applied.  In  addition,  assessments  of  hand  function  
will  be  carried  out  before,  after  and  after  2  weeks  of  the  protocol.
Regarding  the  collection  of  data  on  motor  function,  this  is  carried  out  using  non-invasive  
techniques  so  they  do  not  pose  any  risk  to  the  participant.
Bioethics  of  the  University  of  Burgos
twenty-one
A/A  of  the  President  of  the  Commission
Machine Translated by Google

Compliance  with  Law  14/2007  on  Biomedical  Research,  Organic  Law  3/2018  of  
December  5,  on  the  Protection  of  Personal  Data  and  Guarantee  of  Digital  Rights  
is  guaranteed  (further  information  on  data  protection  may  be  obtained  by  contacting  
with  the  person  indicated  in  the  following  section),  and  Regulation  (EU)  2016/679  of  
the  European  Parliament  and  of  the  Council  of  April  27,  2016  regarding  the  
protection  of  natural  persons  with  regard  to  the  processing  of  personal  data  and  the  free  
circulation  of  these  data  and  by  which  Directive  94/46/EC  (General  Data  Protection  
Regulation)  is  repealed,  especially  with  regard  to  the  sending  and  handling  of  data  to  
third  parties,  so  it  will  not  be  used  or  made  public  no  data  that  could  identify  the  
participants.  The  results  of  the  study  may  be  disseminated  using  the  usual  scientific  
channels  (in  no  case  with  data  that  can  identify  you).
-  Email:  msvazquez@ubu.es
CONTACT  IN  CASE  OF  QUESTIONS  
If  you  have  any  additional  questions  about  this  study  and  your  participation  in  it,  you  
can  contact  Montserrat  Santamaría  Vázquez,  from  the  University  of  Burgos  (UBU).
The  information  you  will  provide  through  the  questionnaire  will  be  protected  through  an  
encryption  process.  Each  participant's  data  will  be  assigned  a  study  code  to  facilitate  
the  completion  of  study  procedures.  Aitor  Martín  Odriozola,  may  relate  your  data,  being  
responsible  for  safeguarding  the  consent  document,  guaranteeing  compliance  with  your  
will  regarding  the  use  of  the  responses  that  you  provide  for  research.  The  data  collected  
will  be  used  only  to  fulfill  the  objectives  of  the  study.
-  Telephone:  630  56  98  20.
A/A  of  the  President  of  the  Commission
22
Bioethics  of  the  University  of  Burgos
Machine Translated by Google

I  freely  give  my  consent  to  participate  in  the  study.
Me  (name  and  surname):
-  I  have  read  the  information  sheet  provided  to  me  and  understand  the  risks  and  benefits  it  entails.
………………………………………………………………………………….
Martin  Odriozola
I  understand  that  participation  is  voluntary  and  I  will  not  receive  any  financial  benefit  for  my  participation.
Organization:  University  of  Burgos
I  understand  that  I  can  withdraw  my  consent:  1st  Whenever  
I  want.  2º  Without  
having  to  give  explanations.  3º  Without  
this  affecting  the  treatment  of  me  as  a  student.
Principal  Investigator:  Dr.  Montserrat  Santamaría  Vázquez
-  I  have  spoken  with:
…………………………………………………………………………………
Collaborating  Researchers:  Juan  Hilario  Ortiz  Huerta,  Olalla  Saiz  Vázquez,  Aitor
INFORMED  CONSENT  FORM.
-  I  have  been  able  to  ask  questions  about  the  study.
-  I  have  received  enough  information  about  the  study.
Date:
Research  project:  Improving  motor  imagination  capacity  through  functional  electrical  
stimulation
Name:
23
Signature  of  the  Participant/Legal  Representative
Bioethics  of  the  University  of  Burgos
Date:
Investigator's  Signature
A/A  of  the  President  of  the  Commission
Name:
Machine Translated by Google