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| Name | Class |
|---|---|
| Politecnico di Milano | OTHER |
| Villa Beretta Rehabilitation Center | OTHER |
| National Research Council | AMBIG |
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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:
Participants will train for 6 months with FES-cycling twice a week. Each session includes at most 30 minutes of stimulation.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FES Bike | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | After 6 months of training |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | After 3 months of training |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scientific Institute, IRCCS E. Medea | Bosisio Parini | Lecco | 23842 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40065341 | Derived | 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. |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| 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. | 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) | 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. | 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. | 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. | One month after the end of the training |
| Changes in the intestinal function | Neurogenic Bowel Dysfunction (NBD) score is used to evaluate intestinal function. | After 3 months of training |
| Changes in the intestinal function | Neurogenic Bowel Dysfunction (NBD) score is used to evaluate intestinal function. | After 6 months of training |
| Changes in the intestinal function | Neurogenic Bowel Dysfunction (NBD) score is used to evaluate intestinal function. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | After 6 months of training |
| D014947 | Wounds and Injuries |