<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04412447</url>
  </required_header>
  <id_info>
    <org_study_id>2019-A00808-49</org_study_id>
    <nct_id>NCT04412447</nct_id>
  </id_info>
  <brief_title>Training for Persons With Complete SCI for FES Cycling: a Case Series</brief_title>
  <official_title>Training of Persons With Complete Spinal Cord Injury for Pedaling on a Tricycle, Induced by Electrical Stimulation of the Paralysed Muscles: a Case Series</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre de Rééducation et Réadaptation Fonctionnelle La Châtaigneraie</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Institut National de Recherche en Informatique et en Automatique</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Université Montpellier</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Centre de Rééducation et Réadaptation Fonctionnelle La Châtaigneraie</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main objective of this study is to validate the effectivity of a simple home-based&#xD;
      training for cycling with functional electrical stimulation (FES). The training is designed&#xD;
      to progressively increase strength and endurance of the paralysed muscles of a person with&#xD;
      complete spinal cord injury. After a limited period of only several months, performance will&#xD;
      be assessed during FES-assisted cycling on a recumbent tricycle over flat ground. The&#xD;
      outcomes of this study should provide evidence for the effectivity of FES-cycling as&#xD;
      potential rehabilitation method.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      People with spinal cord injuries suffer from numerous comorbidities, linked in particular to&#xD;
      immobility and sedentariness. Studies have shown the benefits of training and reconditioning&#xD;
      to adapted effort in spinal cord injured people. Among other innovative techniques,&#xD;
      functional electrical stimulation (FES) is aimed primarily at mobilizing as many muscles as&#xD;
      possible. Concerning electro-stimulated pedaling on a tricycle, it would allow individuals&#xD;
      with paraplegia or tetraplegia to practise physical activity in perspective of experiencing&#xD;
      pleasure during training.&#xD;
&#xD;
      In 2016, our team carried out a pilot study aiming at using a recumbent tricylce powered by&#xD;
      the lower limbs of a person with complete paraplegia under electrostimulation. The&#xD;
      participant was trained for 12 months, whit the objective to participate at an international&#xD;
      competition (Cybathlon 2016). This first study has opened up prospects and identified avenues&#xD;
      for improvement.&#xD;
&#xD;
      The main objective of this study is to significantly improve, over a limited period of time,&#xD;
      the pedalling performance on a tricycle by using electrical stimulation of the sub-lesional&#xD;
      muscles of people with spinal cord injuries. Secondary focusses will be: physical and&#xD;
      psychological tolerance to training; influence on pain, cardio-respiratory functions, body&#xD;
      composition regarding muscle trophicity and bone metabolism; psycho-social impact; impact of&#xD;
      modification of stimulation parameters (frequency, phase width, intensity, waveform, contact&#xD;
      location) in performance optimization and delay of muscle fatigue; performance impact of&#xD;
      mechanical modifications performed on the tricycle.&#xD;
&#xD;
      This is a prospective case study: patients suffering from a complete traumatic injury and&#xD;
      followed at the Centre de Rééducation et de Réadaptation Fonctionnelle (CRRF) La&#xD;
      Châtaigneraie (Menucourt) will be recruited by the investigating physician during a&#xD;
      consultation for a period of approximately 6 months. The centre specialised in the management&#xD;
      of acute and chronic neurological lesions. The eligibility criteria are predefined to ensure&#xD;
      the participants safety. After verification of the criteria and before the start of the&#xD;
      programme, an exercise test (monitoring of the evolution of VO2max) will be carried out in&#xD;
      the Sports Medicine department of the CHI of Saint-Germain-en-Laye. The first phase (V1)&#xD;
      consists of a one-month home-based isometric muscle training programme by electrostimulation&#xD;
      followed by a two-month programme (phase V2) of home-based muscle training by&#xD;
      electrostimulation on an ergocycle including one training per week at the CRRF. The home&#xD;
      ergocycle electro-stimulation muscle training, will be continued once or twice a week and&#xD;
      complemented in the third phase (V3) by training at the CRRF on a tricycle for one month.&#xD;
      Only the patient selected to participate in the Cybathlon 2020 will continue with the final&#xD;
      phase (V4), which includes, over a period of 2 to 4 months, muscle training by&#xD;
      electrostimulation on an ergocycle at home, electrostimulation sessions on a tricycle up to 3&#xD;
      times a week at the CRRF. In this phase, the optimization of the stimulation and electrical&#xD;
      patterns and the mechanics of the tricycle will take place in order to maximize the pilots&#xD;
      overall performance. Finally, the pilot will take part in the tricycle FES-Cycling race at&#xD;
      the Cybathlon 2020 in Zurich, i.e. an international competition and technological challenge,&#xD;
      requiring to master 1200 metres in a maximum time of 8 minutes. The different training&#xD;
      programs are based on sport-scientific principles and a physiotherapist will follow up on the&#xD;
      home sessions. The collaborating teams (engineers and researchers from INRIA, the French&#xD;
      National Institute for Research in Computer Science and Control) will measure performance in&#xD;
      a bimonthly frequency.&#xD;
&#xD;
      This research should demonstrate that the safety, acceptability, satisfaction, self-esteem&#xD;
      and quality of life induced by the practice of FES-assisted pedalling, opens a new way of&#xD;
      training in rehabilitation centres and at home with the perspective of improving certain&#xD;
      physiological functions in the long-term.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">October 1, 2019</start_date>
  <completion_date type="Anticipated">September 2020</completion_date>
  <primary_completion_date type="Anticipated">June 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Training of paralysed musculature of the lower limb by using electrical stimulation.</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Maximum Cycling-Distance in [m]</measure>
    <time_frame>Change between 4 months of training (end of V3) and 6 months of training (end of V4)</time_frame>
    <description>Change in maximum distance cycled on flat ground on a tricycle</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Maximum Cycling-Speed in [km/h]</measure>
    <time_frame>Change between 4 months of training (end of V3) and 6 months of training (end of V4)</time_frame>
    <description>Change in maximum speed during cycling over flat ground on a tricycle</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Average Cycling-Speed in [km/h]</measure>
    <time_frame>Change between 4 months of training (end of V3) and 6 months of training (end of V4)</time_frame>
    <description>Change in average speed during cycling over flat ground on a tricycle</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Maximum Cycling-duration in [hh:mm:ss]</measure>
    <time_frame>Change between 4 months of training (end of V3) and 6 months of training (end of V4)</time_frame>
    <description>Change in maximum duration during cycling over flat ground on a tricycle</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Maximum Pedaling-Cadence in [RPM]</measure>
    <time_frame>Change between 4 months of training (end of V3) and 6 months of training (end of V4)</time_frame>
    <description>Change in maximum pedaling-cadence during cycling over flat ground on a tricycle</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Average Pedaling-Cadence in [RPM]</measure>
    <time_frame>Change between 4 months of training (end of V3) and 6 months of training (end of V4)</time_frame>
    <description>Change in average pedaling-cadence during cycling over flat ground on a tricycle</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Ability to cycle 1200m in less than 8min</measure>
    <time_frame>After 6 months of training (end of V4)</time_frame>
    <description>Qualification criterion Cybathlon 2020. It will be assessed it the pilot is able to cycle 1200m in less than 8min over flat ground on a tricycle.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of blood pressure during training</measure>
    <time_frame>through study completion (up to one year), an average throughout the study-duration</time_frame>
    <description>Blood pressure will be assessed before and after every training session. Mean change in blood pressure will be calculated along all training-sessions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of heart rate during training</measure>
    <time_frame>through study completion (up to one year), an average throughout the study-duration</time_frame>
    <description>Heart rate will be assessed before and after every training session. Mean change in heart-rate will be calculated along all training-sessions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum heart rate during training</measure>
    <time_frame>through study completion (up to one year), an average throughout the study-duration</time_frame>
    <description>Maximum heart rate will be assessed during every training session. Mean and SD of the maximum heart-rate will be calculated along all training-sessions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average heart rate during training</measure>
    <time_frame>through study completion (up to one year), an average throughout the study-duration</time_frame>
    <description>Average heart rate will be assessed during every training session. Mean and SD of the average heart-rate will be calculated along all training-sessions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cutaneous status</measure>
    <time_frame>through study completion (up to one year)</time_frame>
    <description>Evaluation for absence of: skin lesions, pressure points, pressure ulcers, phlebitis, edema</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Musculo-skeletal pain or inflammation</measure>
    <time_frame>through study completion (up to one year)</time_frame>
    <description>Evaluation for absence of: muscular pain, osteo-articular pain or inflammation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychological: Satisfaction</measure>
    <time_frame>through study completion (up to one year), an average throughout the study-duration</time_frame>
    <description>Evaluation of satisfaction [linear scale: 1 - 10; 1 = lowest satisfaction; 10 = highest satisfaction] will be assessed after every training session. Mean and SD of the satisfaction will be calculated along all training-sessions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychological: Acceptability</measure>
    <time_frame>through study completion (up to one year), every 30 days</time_frame>
    <description>Change in acceptability [questionnaire].</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>General Fatigue</measure>
    <time_frame>through study completion (up to one year), an average throughout the study-duration</time_frame>
    <description>Assessment of change in general fatigue via [Borg scale; Range: 6-20; 6 = No exertion, sitting and resting; 20 = Maximal exertion] will be assessed before and after every training session. Mean and SD of the change in fatigue will be calculated along all training-sessions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psycho-Social: Self-Esteem</measure>
    <time_frame>through study completion (up to one year), every 15 days</time_frame>
    <description>Change in self-esteem via [Rosenberg Scale; Range: 10 - 40; 10 = lowest Self-Esteem; 40= Highest Self-Esteem].</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psycho-Social: Quality of Life</measure>
    <time_frame>through study completion (up to one year), every 30 days</time_frame>
    <description>Change in quality-of-life via [questionnaire SF-36].</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardio-Respiratory Fitness: Maximal Heartrate</measure>
    <time_frame>Change between timepoint before first training, after 4 months of training (end of V3) and after 6 months of training (end of V4)</time_frame>
    <description>Change of maximal heartrate via electrocardiogram</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardio-Respiratory Fitness: VO2max</measure>
    <time_frame>Change between timepoint before first training, after 4 months of training (end of V3) and after 6 months of training (end of V4)</time_frame>
    <description>Change of VO2max</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Musculo-skeletal changes: Thigh perimeter</measure>
    <time_frame>Change between timepoint before first training and after end of study (end of V5, ~ 7 months)</time_frame>
    <description>Assessment of thigh perimeter [cm]. Measurement is taken 10cm and 20cm proximal to the proximal edge of the patella.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Musculo-skeletal changes: Bone mineral density</measure>
    <time_frame>Change between timepoint before first training and after end of study (end of V5, ~ 7 months)</time_frame>
    <description>Bone mineral density via [DEXA]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Musculo-skeletal changes: Body composition</measure>
    <time_frame>Change between timepoint before first training and after end of study (end of V5, ~ 7 months)</time_frame>
    <description>Body composition via [DEXA].</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of spasms: before training</measure>
    <time_frame>through study completion (up to one year), an average throughout the study-duration</time_frame>
    <description>Spasmic occurance will be assessed via [PENN Scale; Range: 0-4; 0 = No spasm; 4 = Spasms occuring more than 10 times per hour] before every training session. Mean and SD of the spasmic occurence will be calculated along all training-sessions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of spasms : after training</measure>
    <time_frame>through study completion (up to one year), an average throughout the study-duration</time_frame>
    <description>Spasmic occurance will be assessed via [PENN Scale; Range: 0-4; 0 = No spasm; 4 = Spasms occuring more than 10 times per hour] after every training session. Mean and SD of the spasmic occurence will be calculated along all training-sessions.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>Spinal Cord Injuries</condition>
  <arm_group>
    <arm_group_label>Subjects</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Phase V1: 1 month of home-based FES-training using isometric contractions of quadriceps and hamstring muscles (3 times a week).&#xD;
Phase V2: 2 months of home-based FES-training on an ergo-cycle with arm support (3 times a week)&#xD;
Phase V3: 1 month of home-based FES-training on an ergo-cycle with arm support (1-2 times a week) and FES-cycling training overground on a tricycle (1-2 times a week) in the clinical setting.&#xD;
Optional (only for selected pilot):&#xD;
Phase V4: 2-4 months of home-based FES-training on an ergo-cycle with arm support (1-2 times a week) and FES-cycling training overground on a tricycle (1-2 times a week) in the clinical setting. This phase is focussing on optimizing the performance of the pilot and improving the mechanical efficiency of the tricycle.&#xD;
Phase V5: Participation on Cybathlon 2020</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Functional Electrical Stimulation</intervention_name>
    <description>Electrical stimulation of motor-nerves innervating the musculature of the lower limb.</description>
    <arm_group_label>Subjects</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  informed written consent&#xD;
&#xD;
          -  complete spinal cord injury AIS A or B&#xD;
&#xD;
          -  neurological level of lesion C6 - T12&#xD;
&#xD;
          -  post-lesion duration &gt; 12 moths&#xD;
&#xD;
          -  paralysed muscles stimulable&#xD;
&#xD;
          -  joints of lower limb freely moveable&#xD;
&#xD;
          -  stable medical condition (absence of infectious respiratory or urinary event of&#xD;
             cutaneous pathology confining the patient to bed and warranting treatment).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not affiliated to a social security scheme, beneficiary or not such a plan&#xD;
&#xD;
          -  Refusal to participate in the study (withdraw from study possible at any time)&#xD;
&#xD;
          -  Inability to give consent&#xD;
&#xD;
          -  body mass index higher or equal to 30&#xD;
&#xD;
          -  flaccid paralysis (denervation)&#xD;
&#xD;
          -  Inability to give consent&#xD;
&#xD;
          -  neurogenic para-osteoarthropathy&#xD;
&#xD;
          -  active thrombophlebitis&#xD;
&#xD;
          -  muscular disease&#xD;
&#xD;
          -  cardiovascular disease including coronary antecedent&#xD;
&#xD;
          -  bone mineral density T-score below -2.5&#xD;
&#xD;
          -  treatment with a drug known to have an effect on bone (&lt; 3 months)&#xD;
&#xD;
          -  Aids in the lower limbs&#xD;
&#xD;
          -  Epilepsy&#xD;
&#xD;
          -  Orthostatic hypotension&#xD;
&#xD;
          -  Fractures of the lower limbs older (&lt; 12 months)&#xD;
&#xD;
          -  Pacemakers or other implants contraindicating the use of FES&#xD;
&#xD;
          -  Pregnancy (women)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Centre de Rééducation et de Réadaptation Fonctionnelle La Châtaigneraie</name>
      <address>
        <city>Menucourt</city>
        <zip>95180</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>June 1, 2020</last_update_submitted>
  <last_update_submitted_qc>June 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Cord Injuries</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04412447
org study id: 2019-A00808-49
nct id: NCT04412447
lead sponsor: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The main objective of this study is to validate the effectivity of a simple home-based
      training for cycling with functional electrical stimulation (FES). The training is designed
      to progressively increase strength and endurance of the paralysed muscles of a person with
      complete spinal cord injury. After a limited period of only several months, performance will
      be assessed during FES-assisted cycling on a recumbent tricycle over flat ground. The
      outcomes of this study should provide evidence for the effectivity of FES-cycling as
      potential rehabilitation method.
People with spinal cord injuries suffer from numerous comorbidities, linked in particular to
      immobility and sedentariness. Studies have shown the benefits of training and reconditioning
      to adapted effort in spinal cord injured people. Among other innovative techniques,
      functional electrical stimulation (FES) is aimed primarily at mobilizing as many muscles as
      possible. Concerning electro-stimulated pedaling on a tricycle, it would allow individuals
      with paraplegia or tetraplegia to practise physical activity in perspective of experiencing
      pleasure during training.

      In 2016, our team carried out a pilot study aiming at using a recumbent tricylce powered by
      the lower limbs of a person with complete paraplegia under electrostimulation. The
      participant was trained for 12 months, whit the objective to participate at an international
      competition (Cybathlon 2016). This first study has opened up prospects and identified avenues
      for improvement.

      The main objective of this study is to significantly improve, over a limited period of time,
      the pedalling performance on a tricycle by using electrical stimulation of the sub-lesional
      muscles of people with spinal cord injuries. Secondary focusses will be: physical and
      psychological tolerance to training; influence on pain, cardio-respiratory functions, body
      composition regarding muscle trophicity and bone metabolism; psycho-social impact; impact of
      modification of stimulation parameters (frequency, phase width, intensity, waveform, contact
      location) in performance optimization and delay of muscle fatigue; performance impact of
      mechanical modifications performed on the tricycle.

      This is a prospective case study: patients suffering from a complete traumatic injury and
      followed at the Centre de Rééducation et de Réadaptation Fonctionnelle (CRRF) La
      Châtaigneraie (Menucourt) will be recruited by the investigating physician during a
      consultation for a period of approximately 6 months. The centre specialised in the management
      of acute and chronic neurological lesions. The eligibility criteria are predefined to ensure
      the participants safety. After verification of the criteria and before the start of the
      programme, an exercise test (monitoring of the evolution of VO2max) will be carried out in
      the Sports Medicine department of the CHI of Saint-Germain-en-Laye. The first phase (V1)
      consists of a one-month home-based isometric muscle training programme by electrostimulation
      followed by a two-month programme (phase V2) of home-based muscle training by
      electrostimulation on an ergocycle including one training per week at the CRRF. The home
      ergocycle electro-stimulation muscle training, will be continued once or twice a week and
      complemented in the third phase (V3) by training at the CRRF on a tricycle for one month.
      Only the patient selected to participate in the Cybathlon 2020 will continue with the final
      phase (V4), which includes, over a period of 2 to 4 months, muscle training by
      electrostimulation on an ergocycle at home, electrostimulation sessions on a tricycle up to 3
      times a week at the CRRF. In this phase, the optimization of the stimulation and electrical
      patterns and the mechanics of the tricycle will take place in order to maximize the pilots
      overall performance. Finally, the pilot will take part in the tricycle FES-Cycling race at
      the Cybathlon 2020 in Zurich, i.e. an international competition and technological challenge,
      requiring to master 1200 metres in a maximum time of 8 minutes. The different training
      programs are based on sport-scientific principles and a physiotherapist will follow up on the
      home sessions. The collaborating teams (engineers and researchers from INRIA, the French
      National Institute for Research in Computer Science and Control) will measure performance in
      a bimonthly frequency.

      This research should demonstrate that the safety, acceptability, satisfaction, self-esteem
      and quality of life induced by the practice of FES-assisted pedalling, opens a new way of
      training in rehabilitation centres and at home with the perspective of improving certain
      physiological functions in the long-term.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Training of paralysed musculature of the lower limb by using electrical stimulation.
primary purpose: Basic Science
masking: None (Open Label)
measure: Change in Maximum Cycling-Distance in [m]
time frame: Change between 4 months of training (end of V3) and 6 months of training (end of V4)
description: Change in maximum distance cycled on flat ground on a tricycle
measure: Change in Maximum Cycling-Speed in [km/h]
time frame: Change between 4 months of training (end of V3) and 6 months of training (end of V4)
description: Change in maximum speed during cycling over flat ground on a tricycle
measure: Change in Average Cycling-Speed in [km/h]
time frame: Change between 4 months of training (end of V3) and 6 months of training (end of V4)
description: Change in average speed during cycling over flat ground on a tricycle
measure: Change in Maximum Cycling-duration in [hh:mm:ss]
time frame: Change between 4 months of training (end of V3) and 6 months of training (end of V4)
description: Change in maximum duration during cycling over flat ground on a tricycle
measure: Change in Maximum Pedaling-Cadence in [RPM]
time frame: Change between 4 months of training (end of V3) and 6 months of training (end of V4)
description: Change in maximum pedaling-cadence during cycling over flat ground on a tricycle
measure: Change in Average Pedaling-Cadence in [RPM]
time frame: Change between 4 months of training (end of V3) and 6 months of training (end of V4)
description: Change in average pedaling-cadence during cycling over flat ground on a tricycle
measure: Ability to cycle 1200m in less than 8min
time frame: After 6 months of training (end of V4)
description: Qualification criterion Cybathlon 2020. It will be assessed it the pilot is able to cycle 1200m in less than 8min over flat ground on a tricycle.
measure: Change of blood pressure during training
time frame: through study completion (up to one year), an average throughout the study-duration
description: Blood pressure will be assessed before and after every training session. Mean change in blood pressure will be calculated along all training-sessions.
measure: Change of heart rate during training
time frame: through study completion (up to one year), an average throughout the study-duration
description: Heart rate will be assessed before and after every training session. Mean change in heart-rate will be calculated along all training-sessions.
measure: Maximum heart rate during training
time frame: through study completion (up to one year), an average throughout the study-duration
description: Maximum heart rate will be assessed during every training session. Mean and SD of the maximum heart-rate will be calculated along all training-sessions.
measure: Average heart rate during training
time frame: through study completion (up to one year), an average throughout the study-duration
description: Average heart rate will be assessed during every training session. Mean and SD of the average heart-rate will be calculated along all training-sessions.
measure: Cutaneous status
time frame: through study completion (up to one year)
description: Evaluation for absence of: skin lesions, pressure points, pressure ulcers, phlebitis, edema
measure: Musculo-skeletal pain or inflammation
time frame: through study completion (up to one year)
description: Evaluation for absence of: muscular pain, osteo-articular pain or inflammation
measure: Psychological: Satisfaction
time frame: through study completion (up to one year), an average throughout the study-duration
description: Evaluation of satisfaction [linear scale: 1 - 10; 1 = lowest satisfaction; 10 = highest satisfaction] will be assessed after every training session. Mean and SD of the satisfaction will be calculated along all training-sessions.
measure: Psychological: Acceptability
time frame: through study completion (up to one year), every 30 days
description: Change in acceptability [questionnaire].
measure: General Fatigue
time frame: through study completion (up to one year), an average throughout the study-duration
description: Assessment of change in general fatigue via [Borg scale; Range: 6-20; 6 = No exertion, sitting and resting; 20 = Maximal exertion] will be assessed before and after every training session. Mean and SD of the change in fatigue will be calculated along all training-sessions.
measure: Psycho-Social: Self-Esteem
time frame: through study completion (up to one year), every 15 days
description: Change in self-esteem via [Rosenberg Scale; Range: 10 - 40; 10 = lowest Self-Esteem; 40= Highest Self-Esteem].
measure: Psycho-Social: Quality of Life
time frame: through study completion (up to one year), every 30 days
description: Change in quality-of-life via [questionnaire SF-36].
measure: Cardio-Respiratory Fitness: Maximal Heartrate
time frame: Change between timepoint before first training, after 4 months of training (end of V3) and after 6 months of training (end of V4)
description: Change of maximal heartrate via electrocardiogram
measure: Cardio-Respiratory Fitness: VO2max
time frame: Change between timepoint before first training, after 4 months of training (end of V3) and after 6 months of training (end of V4)
description: Change of VO2max
measure: Musculo-skeletal changes: Thigh perimeter
time frame: Change between timepoint before first training and after end of study (end of V5, ~ 7 months)
description: Assessment of thigh perimeter [cm]. Measurement is taken 10cm and 20cm proximal to the proximal edge of the patella.
measure: Musculo-skeletal changes: Bone mineral density
time frame: Change between timepoint before first training and after end of study (end of V5, ~ 7 months)
description: Bone mineral density via [DEXA]
measure: Musculo-skeletal changes: Body composition
time frame: Change between timepoint before first training and after end of study (end of V5, ~ 7 months)
description: Body composition via [DEXA].
measure: Occurrence of spasms: before training
time frame: through study completion (up to one year), an average throughout the study-duration
description: Spasmic occurance will be assessed via [PENN Scale; Range: 0-4; 0 = No spasm; 4 = Spasms occuring more than 10 times per hour] before every training session. Mean and SD of the spasmic occurence will be calculated along all training-sessions.
measure: Occurrence of spasms : after training
time frame: through study completion (up to one year), an average throughout the study-duration
description: Spasmic occurance will be assessed via [PENN Scale; Range: 0-4; 0 = No spasm; 4 = Spasms occuring more than 10 times per hour] after every training session. Mean and SD of the spasmic occurence will be calculated along all training-sessions.
arm group label: Subjects
arm group type: Experimental
description: Phase V1: 1 month of home-based FES-training using isometric contractions of quadriceps and hamstring muscles (3 times a week).
Phase V2: 2 months of home-based FES-training on an ergo-cycle with arm support (3 times a week)
Phase V3: 1 month of home-based FES-training on an ergo-cycle with arm support (1-2 times a week) and FES-cycling training overground on a tricycle (1-2 times a week) in the clinical setting.
Optional (only for selected pilot):
Phase V4: 2-4 months of home-based FES-training on an ergo-cycle with arm support (1-2 times a week) and FES-cycling training overground on a tricycle (1-2 times a week) in the clinical setting. This phase is focussing on optimizing the performance of the pilot and improving the mechanical efficiency of the tricycle.
Phase V5: Participation on Cybathlon 2020
intervention type: Device
intervention name: Functional Electrical Stimulation
description: Electrical stimulation of motor-nerves innervating the musculature of the lower limb.
arm group label: Subjects
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Spinal Cord Injuries