Spinal Cord InjuriesFES-BikeNCT06321172
Muscle and Bone Changes After 6 Months of FES Cycling
A study testing FES Bike in people with Spinal Cord Injuries, run by IRCCS Eugenio Medea at 1 site in Italy.
Trial summary
The goal of this clinical trial is to assess the effectiveness of FES cycling in terms of changes morpho-functional characteristics of the leg muscles, training performance and bone trophism in 5 subjects with Spinal Cord Injury after 6 months of training. 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?
- FES Bike
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteItaly
- Study dates
- 9 Sep 2022to 29 Apr 2024
- 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
- Age of subjects between 18 and 65 years.
- Subjects with paraplegia resulting from a SCI with both traumatic and non-traumatic origins occurred less than 5 years before the start of the study.
- Complete loss of motor function in the lower limbs (level ≤ T3, American Spinal Injury Association (ASIA) scale A or B)
- Adequate control of the trunk and sufficient muscle contraction using FES with surface electrodes.
- Preference for subjects with an aptitude for sports practice.
- Absence of a level of spasticity preventing device use and of disabling pain during training
Who cannot join
- Critical osteoporosis
- Skin lesions in interfaces parts with the trike,
- Dysfunction of the autonomic nervous system, and
- Psychopathological comorbidities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preliminary Evaluation of the Effectiveness of FES Cycling in Terms of Training Performance, Morpho-functional Characteristics of the Leg Muscles and Bone Trophism After 6 Months of Training in Spinal Cord Injury Subjects
The goal of this clinical trial is to assess the effectiveness of FES cycling in terms of changes morpho-functional characteristics of the leg muscles, training performance and bone trophism in 5 subjects with Spinal Cord Injury after 6 months of training. The main question[s] it aims to answer are:
- Do the morpho-functional characteristics of the leg muscles improve after 3 and 6 months of training with FES cycling? If any, the morpho-functional improvements are maintained one month after the end of the training?
- Does the quality of the leg bones improve after 3 and 6 months of training with FES cycling?
- Does the training performance improve during the training with FES cycling?
- Do the data referred to the vegetative nervous system change after 3 and 6 months of training with FES cycling? If yes, the changes in the vegetative nervous system are maintained one month after the end of the training?
- Does the intestinal function change after 3 and 6 months of training with FES cycling? If yes, the changes are maintained one month after the end of the training?
- Does the level of spasticity of the lower limbs change after 3 and 6 months of training with FES cycling? If yes, the changes are maintained one month after the end of the training?
- Does the level of pain perceived by pilots change after 3 and 6 months of training with FES cycling? If yes, the changes are maintained one month after the end of the training?
- Does the Psychological General Well-Being of the pilots change after 3 and 6 months of training with FES cycling? If yes, the changes are maintained one month after the end of the training?
- Does the pilots' motivation in carrying out a sporting activity change between T1 (3 months after starting the training) and T2(6 months after starting the training)?
Participants will train for 6 months with FES-cycling twice a week. Each session includes at most 30 minutes of stimulation.
Read the detailed description
Six months of FES-cycling trainings twice a week is performed for each pilot. Each session includes at most 30 minutes of stimulation.
At the beginning of training period, a conditioning phase is performed until the pilot reaches pedalling autonomy. This period is also used to define the stimulation parameters (minimum and maximum values of current intensity and pulse width), reference cadence and gear, specific for the ability of each pilot. Then the training period start and is performed indoor, setting the resistance of the smart trainer at 10% for all the participants. The sessions are organized as follows: a 3-minute warmup followed by four sets of 6 minutes of pedalling and a 3-minute cool down.
- Conditions
- Spinal Cord Injuries
- Being tested
- FES Bike
- Keywords
- Spinal Cord Injury, FES, FES cycling
- 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.
FES BikeDevice
Six months of FES-cycling trainings twice a week is performed for each pilot. Each session includes at most 30 minutes of stimulation. At the beginning of the training period, a conditioning phase is performed until the pilot reaches pedalling autonomy. This period is also used to define the stimulation parameters (minimum and maximum values of current intensity and pulse width), reference cadence and gear, specific for the ability of each pilot. Then the training period starts and is performed indoor, setting the resistance of the smart trainer at 10% for all the participants. The sessions are organized as follows: a 3-minute warmup followed by four sets of 6 minutes of pedalling and a 3-minute cool down.
| Study group | Role | What they receive |
|---|---|---|
| FES cycling group | Experimental | Six months of FES-cycling trainings twice a week were performed for each pilot. Each session includes at most 30 minutes of stimulation. Receives: Device: FES Bike |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the morpho-functional characteristics of the thigh muscles of the dominant limb
The primary outcome is the changes in the morpho-functional characteristics of the thigh muscles of the dominant limb, which is investigated with the Magnetic Resonance Imaging (MRI) with multiparametric investigation methods.
Measured: After 6 months of training
Secondary outcomes (20)
Changes in the morpho-functional characteristics of the thigh muscles of the dominant limb
The primary outcome is the changes in the morpho-functional characteristics of the thigh muscles of the dominant limb, which is investigated with the Magnetic Resonance Imaging (MRI) with multiparametric investigation methods.
Measured: After 3 months of training
Changes in the morpho-functional characteristics of the thigh muscles of the dominant limb
The primary outcome is the changes in the morpho-functional characteristics of the thigh muscles of the dominant limb, which is investigated with the Magnetic Resonance Imaging (MRI) with multiparametric investigation methods.
Measured: One month after the end of the training
Changes in bone quality
The evaluation of improvements in the quality of the leg bones is performed with the Bone Mineral Density (BMD)
Measured: After 6 months of training
Changes in data referring to the vegetative nervous system
The evaluation of vegetative nervous system includes a series of test: at the beginning a rest test, then a standing test and a stepping test using a step automatic induction system (Erigo, Hocoma) and finally a cycling test (LAMBDA). For all these tests, heart rate (HR), systolic and diastolic blood pressure (sBP and dBP) and total peripheral resistance index (TPRI) are recorded.
Measured: After 3 months of training
Changes in data referring to the vegetative nervous system
The evaluation of vegetative nervous system includes a series of test: at the beginning a rest test, then a standing test and a stepping test using a step automatic induction system (Erigo, Hocoma) and finally a cycling test (LAMBDA). For all these tests, heart rate (HR), systolic and diastolic blood pressure (sBP and dBP) and total peripheral resistance index (TPRI) are recorded.
Measured: After 6 months of training
Changes in data referring to the vegetative nervous system
The evaluation of vegetative nervous system includes a series of test: at the beginning a rest test, then a standing test and a stepping test using a step automatic induction system (Erigo, Hocoma) and finally a cycling test (LAMBDA). For all these tests, heart rate (HR), systolic and diastolic blood pressure (sBP and dBP) and total peripheral resistance index (TPRI) are recorded.
Measured: One month after the end of the training
Changes in the intestinal function
Neurogenic Bowel Dysfunction (NBD) score is used to evaluate intestinal function.
Measured: After 3 months of training
Changes in the intestinal function
Neurogenic Bowel Dysfunction (NBD) score is used to evaluate intestinal function.
Measured: After 6 months of training
Changes in the intestinal function
Neurogenic Bowel Dysfunction (NBD) score is used to evaluate intestinal function.
Measured: One month after the end of the training
Changes in the level of spasticity of the lower limbs
To determine the level of spasticity in the lower limbs the Modified Ashworth scale (MAS) is used.
Measured: After 3 months of training
Changes in the level of spasticity of the lower limbs
To determine the level of spasticity in the lower limbs the Modified Ashworth scale (MAS) is used.
Measured: After 6 months of training
Changes in the level of spasticity of the lower limbs
To determine the level of spasticity in the lower limbs the Modified Ashworth scale (MAS) is used.
Measured: One month after the end of the training
Changes in the level of pain perceived
Numerical Rating Scale (NRS) to quantify the level of pain perceived by the subject.
Measured: After 3 months of training
Changes in the level of pain perceived
Numerical Rating Scale (NRS) to quantify the level of pain perceived by the subject.
Measured: After 6 months of training
Changes in the level of pain perceived
Numerical Rating Scale (NRS) to quantify the level of pain perceived by the subject.
Measured: One month after the end of the training
Changes in the General Well Being of the pilots while training
Psychological General Well-Being Index (PGWBI) is used to evaluate any repercussions that continuous FES-cycling activity has carried out on the well-being of the participants.
Measured: After 3 months of training
Changes in the General Well Being of the pilots while training
Psychological General Well-Being Index (PGWBI) is used to evaluate any repercussions that continuous FES-cycling activity has carried out on the well-being of the participants.
Measured: After 6 months of training
Changes in the General Well Being of the pilots while training
Psychological General Well-Being Index (PGWBI) is used to evaluate any repercussions that continuous FES-cycling activity has carried out on the well-being of the participants.
Measured: One month after the end of the training
Pilots' motivation in carrying out a sporting activity
Sport Motivation Scale questionnaire is administered to evaluate the drivers' motivation in carrying out a sporting activity.
Measured: After 3 months of training
Pilots' motivation in carrying out a sporting activity
Sport Motivation Scale questionnaire is administered to evaluate the drivers' motivation in carrying out a sporting activity.
Measured: After 6 months of training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start9 Sep 2022
- Primary completion22 Jan 2024
- Study completion29 Apr 2024
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.
- More trials run by IRCCS Eugenio MedeaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Eugenio Medea
- Sponsor type
- University, hospital or other
- Collaborators
- Politecnico di Milano, Villa Beretta Rehabilitation Center, National Research Council
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06321172
- Sponsor's protocol ID
- 785
- Acronym
- FES-Bike
- Status last verified
- Oct 2024
- First submitted
- 14 Mar 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sanna N, Nossa R, Biffi E, Guanziroli E, Diella E, Ferrante S, Molteni F, Peruzzo D, Casali N, Mastropietro A, Rizzo G, Tarabini M, Pedrocchi A, Ambrosini E. Evaluating the health and fitness benefits of a 6-month FES-cycling program on a recumbent trike for individuals with motor complete SCI: a pilot study. J Neuroeng Rehabil. 2025 Mar 10;22(1):55. doi: 10.1186/s12984-025-01585-0.
PubMed 40065341
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Evaluation of the Effectiveness of FES Cycling in Terms of Training Performance, Morpho-functional Characteristics of the Leg Muscles and Bone Trophism After 6 Months of Training in Spinal Cord Injury Subjects
- ClinicalTrials.gov ID
- NCT06321172
- Acronym / sponsor ID
- FES-Bike / 785
- Conditions
- Spinal Cord Injuries
- Keywords
- Spinal Cord Injury, FES, FES cycling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- IRCCS Eugenio MedeaUniversity, hospital or other
- Collaborators
- Politecnico di Milano, Villa Beretta Rehabilitation Center, National Research Council
- Study start
- 9 Sep 2022 (actual)
- Primary completion
- 22 Jan 2024 (actual)
- Study completion
- 29 Apr 2024 (actual)
- First posted
- 20 Mar 2024 (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 goal of this clinical trial is to assess the effectiveness of FES cycling in terms of changes morpho-functional characteristics of the leg muscles, training performance and bone trophism in 5 subjects with Spinal Cord Injury after 6 months of training. The main question[s] it aims to answer are:
- Do the morpho-functional characteristics of the leg muscles improve after 3 and 6 months of training with FES cycling? If any, the morpho-functional improvements are maintained one month after the end of the training?
- Does the quality of the leg bones improve after 3 and 6 months of training with FES cycling?
- Does the training performance improve during the training with FES cycling?
- Do the data referred to the vegetative nervous system change after 3 and 6 months of training with FES cycling? If yes, the changes in the vegetative nervous system are maintained one month after the end of the training?
- Does the intestinal function change after 3 and 6 months of training with FES cycling? If yes, the changes are maintained one month after the end of the training?
- Does the level of spasticity of the lower limbs change after 3 and 6 months of training with FES cycling? If yes, the changes are maintained one month after the end of the training?
- Does the level of pain perceived by pilots change after 3 and 6 months of training with FES cycling? If yes, the changes are maintained one month after the end of the training?
- Does the Psychological General Well-Being of the pilots change after 3 and 6 months of training with FES cycling? If yes, the changes are maintained one month after the end of the training?
- Does the pilots' motivation in carrying out a sporting activity change between T1 (3 months after starting the training) and T2(6 months after starting the training)?
Participants will train for 6 months with FES-cycling twice a week. Each session includes at most 30 minutes of stimulation.
Detailed description
Six months of FES-cycling trainings twice a week is performed for each pilot. Each session includes at most 30 minutes of stimulation.
At the beginning of training period, a conditioning phase is performed until the pilot reaches pedalling autonomy. This period is also used to define the stimulation parameters (minimum and maximum values of current intensity and pulse width), reference cadence and gear, specific for the ability of each pilot. Then the training period start and is performed indoor, setting the resistance of the smart trainer at 10% for all the participants. The sessions are organized as follows: a 3-minute warmup followed by four sets of 6 minutes of pedalling and a 3-minute cool down.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FES cycling group | Experimental | Device: FES BikeSix months of FES-cycling trainings twice a week were performed for each pilot. Each session includes at most 30 minutes of stimulation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age of subjects between 18 and 65 years.
- Subjects with paraplegia resulting from a SCI with both traumatic and non-traumatic origins occurred less than 5 years before the start of the study.
- Complete loss of motor function in the lower limbs (level ≤ T3, American Spinal Injury Association (ASIA) scale A or B)
- Adequate control of the trunk and sufficient muscle contraction using FES with surface electrodes.
- Preference for subjects with an aptitude for sports practice.
Key exclusion criteria (4 listed)
- Critical osteoporosis
- Skin lesions in interfaces parts with the trike,
- Dysfunction of the autonomic nervous system, and
- Psychopathological comorbidities
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 |
|---|---|---|
| FES BikeSix months of FES-cycling trainings twice a week is performed for each pilot. Each session includes at most 30 minutes of stimulation. At the beginning of the training period, a conditioning phase is performed until the pilot reaches pedalling autonomy. This period is also used to define the stimulation parameters (minimum and maximum values of current intensity and pulse width), reference cadence and gear, specific for the ability of each pilot. Then the training period starts and is performed indoor, setting the resistance of the smart trainer at 10% for all the participants. The sessions are organized as follows: a 3-minute warmup followed by four sets of 6 minutes of pedalling and a 3-minute cool down. | Device | FES cycling group |
Primary outcome
Changes in the morpho-functional characteristics of the thigh muscles of the dominant limb
Time frame: After 6 months of training
The primary outcome is the changes in the morpho-functional characteristics of the thigh muscles of the dominant limb, which is investigated with the Magnetic Resonance Imaging (MRI) with multiparametric investigation methods.
20 secondary outcomes
Changes in the morpho-functional characteristics of the thigh muscles of the dominant limb
Time frame: After 3 months of training
Changes in the morpho-functional characteristics of the thigh muscles of the dominant limb
Time frame: One month after the end of the training
Changes in bone quality
Time frame: After 6 months of training
Changes in data referring to the vegetative nervous system
Time frame: After 3 months of training
Changes in data referring to the vegetative nervous system
Time frame: After 6 months of training
Changes in data referring to the vegetative nervous system
Time frame: One month after the end of the training
Changes in the intestinal function
Time frame: After 3 months of training
Changes in the intestinal function
Time frame: After 6 months of training
Changes in the intestinal function
Time frame: One month after the end of the training
Changes in the level of spasticity of the lower limbs
Time frame: After 3 months of training
Changes in the level of spasticity of the lower limbs
Time frame: After 6 months of training
Changes in the level of spasticity of the lower limbs
Time frame: One month after the end of the training
Changes in the level of pain perceived
Time frame: After 3 months of training
Changes in the level of pain perceived
Time frame: After 6 months of training
Changes in the level of pain perceived
Time frame: One month after the end of the training
Changes in the General Well Being of the pilots while training
Time frame: After 3 months of training
Changes in the General Well Being of the pilots while training
Time frame: After 6 months of training
Changes in the General Well Being of the pilots while training
Time frame: One month after the end of the training
Pilots' motivation in carrying out a sporting activity
Time frame: After 3 months of training
Pilots' motivation in carrying out a sporting activity
Time frame: After 6 months of training
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Derived from this study: PubMed 40065341Sanna N, Nossa R, Biffi E, Guanziroli E, Diella E, Ferrante S, Molteni F, Peruzzo D, Casali N, Mastropietro A, Rizzo G, Tarabini M, Pedrocchi A, Ambrosini E. Evaluating the health and fitness benefits of a 6-month FES-cycling program on a recumbent trike for individuals with motor complete SCI: a pilot study. J Neuroeng Rehabil. 2025 Mar 10;22(1):55. doi: 10.1186/s12984-025-01585-0.
- Individual participant dataSharing planned: Undecided
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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 FES Bike in people with Spinal Cord Injuries, run by IRCCS Eugenio Medea at 1 site in Italy.
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 6 inclusion and 4 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: finished, as of the sponsor's last update on 8 Oct 2024. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in the morpho-functional characteristics of the thigh muscles of the dominant limb (time frame: After 6 months of training). 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 NCT06321172, 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 8 Oct 2024; AzTrials last refreshed its copy on 7 Nov 2026.