Spinal Cord InjuriesNCT04412447
Training for Persons With Complete SCI for FES Cycling: a Case Series
A study testing Functional Electrical Stimulation in people with Spinal Cord Injuries, run by Centre de Rééducation et Réadaptation Fonctionnelle La Châtaigneraie at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Functional Electrical Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2019to Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- informed written consent
- complete spinal cord injury AIS A or B
- neurological level of lesion C6 - T12
- post-lesion duration > 12 moths
- paralysed muscles stimulable
- joints of lower limb freely moveable
- stable medical condition (absence of infectious respiratory or urinary event of cutaneous pathology confining the patient to bed and warranting treatment).
Who cannot join
- Not affiliated to a social security scheme, beneficiary or not such a plan
- Refusal to participate in the study (withdraw from study possible at any time)
- Inability to give consent
- body mass index higher or equal to 30
- flaccid paralysis (denervation)
- Inability to give consent
Show all 18Show fewer
- neurogenic para-osteoarthropathy
- active thrombophlebitis
- muscular disease
- cardiovascular disease including coronary antecedent
- bone mineral density T-score below -2.5
- treatment with a drug known to have an effect on bone (< 3 months)
- Aids in the lower limbs
- Epilepsy
- Orthostatic hypotension
- Fractures of the lower limbs older (< 12 months)
- Pacemakers or other implants contraindicating the use of FES
- Pregnancy (women)
Trial locations and contacts
1 site in 1 country.
France1 site
Centre de Rééducation et de Réadaptation Fonctionnelle La Châtaigneraie
Menucourt, 95180
About this study
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
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.
Read the detailed description
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.
- Conditions
- Spinal Cord Injuries
- Being tested
- Functional Electrical Stimulation
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Electrical StimulationDevice
Electrical stimulation of motor-nerves innervating the musculature of the lower limb.
| Study group | Role | What they receive |
|---|---|---|
| Subjects | Experimental | 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 Receives: Device: Functional Electrical Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Maximum Cycling-Distance in [m]
Change in maximum distance cycled on flat ground on a tricycle
Measured: Change between 4 months of training (end of V3) and 6 months of training (end of V4)
Change in Maximum Cycling-Speed in [km/h]
Change in maximum speed during cycling over flat ground on a tricycle
Measured: Change between 4 months of training (end of V3) and 6 months of training (end of V4)
Change in Average Cycling-Speed in [km/h]
Change in average speed during cycling over flat ground on a tricycle
Measured: Change between 4 months of training (end of V3) and 6 months of training (end of V4)
Change in Maximum Cycling-duration in [hh:mm:ss]
Change in maximum duration during cycling over flat ground on a tricycle
Measured: Change between 4 months of training (end of V3) and 6 months of training (end of V4)
Change in Maximum Pedaling-Cadence in [RPM]
Change in maximum pedaling-cadence during cycling over flat ground on a tricycle
Measured: Change between 4 months of training (end of V3) and 6 months of training (end of V4)
Change in Average Pedaling-Cadence in [RPM]
Change in average pedaling-cadence during cycling over flat ground on a tricycle
Measured: Change between 4 months of training (end of V3) and 6 months of training (end of V4)
Ability to cycle 1200m in less than 8min
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.
Measured: After 6 months of training (end of V4)
Secondary outcomes (18)
Change of blood pressure during training
Blood pressure will be assessed before and after every training session. Mean change in blood pressure will be calculated along all training-sessions.
Measured: through study completion (up to one year), an average throughout the study-duration
Change of heart rate during training
Heart rate will be assessed before and after every training session. Mean change in heart-rate will be calculated along all training-sessions.
Measured: through study completion (up to one year), an average throughout the study-duration
Maximum heart rate during training
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.
Measured: through study completion (up to one year), an average throughout the study-duration
Average heart rate during training
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.
Measured: through study completion (up to one year), an average throughout the study-duration
Cutaneous status
Evaluation for absence of: skin lesions, pressure points, pressure ulcers, phlebitis, edema
Measured: through study completion (up to one year)
Musculo-skeletal pain or inflammation
Evaluation for absence of: muscular pain, osteo-articular pain or inflammation
Measured: through study completion (up to one year)
Psychological: Satisfaction
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.
Measured: through study completion (up to one year), an average throughout the study-duration
Psychological: Acceptability
Change in acceptability [questionnaire].
Measured: through study completion (up to one year), every 30 days
General Fatigue
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.
Measured: through study completion (up to one year), an average throughout the study-duration
Psycho-Social: Self-Esteem
Change in self-esteem via [Rosenberg Scale; Range: 10 - 40; 10 = lowest Self-Esteem; 40= Highest Self-Esteem].
Measured: through study completion (up to one year), every 15 days
Psycho-Social: Quality of Life
Change in quality-of-life via [questionnaire SF-36].
Measured: through study completion (up to one year), every 30 days
Cardio-Respiratory Fitness: Maximal Heartrate
Change of maximal heartrate via electrocardiogram
Measured: Change between timepoint before first training, after 4 months of training (end of V3) and after 6 months of training (end of V4)
Cardio-Respiratory Fitness: VO2max
Change of VO2max
Measured: Change between timepoint before first training, after 4 months of training (end of V3) and after 6 months of training (end of V4)
Musculo-skeletal changes: Thigh perimeter
Assessment of thigh perimeter [cm]. Measurement is taken 10cm and 20cm proximal to the proximal edge of the patella.
Measured: Change between timepoint before first training and after end of study (end of V5, ~ 7 months)
Musculo-skeletal changes: Bone mineral density
Bone mineral density via [DEXA]
Measured: Change between timepoint before first training and after end of study (end of V5, ~ 7 months)
Musculo-skeletal changes: Body composition
Body composition via [DEXA].
Measured: Change between timepoint before first training and after end of study (end of V5, ~ 7 months)
Occurrence of spasms: before training
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.
Measured: through study completion (up to one year), an average throughout the study-duration
Occurrence of spasms : after training
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.
Measured: through study completion (up to one year), an average throughout the study-duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2020
- Study start1 Oct 2019
- Primary completionJun 2020 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Training of paralysed musculature of the lower limb by using electrical stimulation.
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre de Rééducation et Réadaptation Fonctionnelle La Châtaigneraie
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de Recherche en Informatique et en Automatique, Université Montpellier
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04412447
- Sponsor's protocol ID
- 2019-A00808-49
- Status last verified
- Jun 2020
- First submitted
- 11 May 2020
- Last updated
- 2 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fattal C, Schmoll M, Le Guillou R, Raoult B, Frey A, Carlier R, Azevedo-Coste C. Benefits of 1-Yr Home Training With Functional Electrical Stimulation Cycling in Paraplegia During COVID-19 Crisis. Am J Phys Med Rehabil. 2021 Dec 1;100(12):1148-1151. doi: 10.1097/PHM.0000000000001898.
PubMed 34596097
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04412447
- Acronym / sponsor ID
- 2019-A00808-49
- Conditions
- Spinal Cord Injuries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Centre de Rééducation et Réadaptation Fonctionnelle La ChâtaigneraieUniversity, hospital or other
- Collaborators
- Institut National de Recherche en Informatique et en Automatique, Université Montpellier
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 2 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Training of paralysed musculature of the lower limb by using electrical stimulation.
| Arm | Type | Receives |
|---|---|---|
| Subjects | Experimental | Device: Functional Electrical StimulationPhase 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- informed written consent
- complete spinal cord injury AIS A or B
- neurological level of lesion C6 - T12
- post-lesion duration > 12 moths
- paralysed muscles stimulable
Key exclusion criteria (18 listed)
- Not affiliated to a social security scheme, beneficiary or not such a plan
- Refusal to participate in the study (withdraw from study possible at any time)
- Inability to give consent
- body mass index higher or equal to 30
- flaccid paralysis (denervation)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional Electrical StimulationElectrical stimulation of motor-nerves innervating the musculature of the lower limb. | Device | Subjects |
Primary outcome
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)
Change in maximum distance cycled on flat ground on a tricycle
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)
Change in maximum speed during cycling over flat ground on a tricycle
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)
Change in average speed during cycling over flat ground on a tricycle
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)
Change in maximum duration during cycling over flat ground on a tricycle
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)
Change in maximum pedaling-cadence during cycling over flat ground on a tricycle
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)
Change in average pedaling-cadence during cycling over flat ground on a tricycle
Ability to cycle 1200m in less than 8min
Time frame: After 6 months of training (end of V4)
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.
18 secondary outcomes
Change of blood pressure during training
Time frame: through study completion (up to one year), an average throughout the study-duration
Change of heart rate during training
Time frame: through study completion (up to one year), an average throughout the study-duration
Maximum heart rate during training
Time frame: through study completion (up to one year), an average throughout the study-duration
Average heart rate during training
Time frame: through study completion (up to one year), an average throughout the study-duration
Cutaneous status
Time frame: through study completion (up to one year)
Musculo-skeletal pain or inflammation
Time frame: through study completion (up to one year)
Psychological: Satisfaction
Time frame: through study completion (up to one year), an average throughout the study-duration
Psychological: Acceptability
Time frame: through study completion (up to one year), every 30 days
General Fatigue
Time frame: through study completion (up to one year), an average throughout the study-duration
Psycho-Social: Self-Esteem
Time frame: through study completion (up to one year), every 15 days
Psycho-Social: Quality of Life
Time frame: through study completion (up to one year), every 30 days
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)
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)
Musculo-skeletal changes: Thigh perimeter
Time frame: Change between timepoint before first training and after end of study (end of V5, ~ 7 months)
Musculo-skeletal changes: Bone mineral density
Time frame: Change between timepoint before first training and after end of study (end of V5, ~ 7 months)
Musculo-skeletal changes: Body composition
Time frame: Change between timepoint before first training and after end of study (end of V5, ~ 7 months)
Occurrence of spasms: before training
Time frame: through study completion (up to one year), an average throughout the study-duration
Occurrence of spasms : after training
Time frame: through study completion (up to one year), an average throughout the study-duration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2020.
- Derived from this study: PubMed 34596097Fattal C, Schmoll M, Le Guillou R, Raoult B, Frey A, Carlier R, Azevedo-Coste C. Benefits of 1-Yr Home Training With Functional Electrical Stimulation Cycling in Paraplegia During COVID-19 Crisis. Am J Phys Med Rehabil. 2021 Dec 1;100(12):1148-1151. doi: 10.1097/PHM.0000000000001898.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Electrical Stimulation in people with Spinal Cord Injuries, run by Centre de Rééducation et Réadaptation Fonctionnelle La Châtaigneraie at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04412447, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2020.