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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
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.
Scientific Institute, IRCCS E. Medea
Bosisio Parini, Lecco, Italy
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.
Time frame: After 6 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.
Time frame: 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.
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: One month after the end of the training
Changes in the intestinal function
Neurogenic Bowel Dysfunction (NBD) score is used to evaluate intestinal function.
Time frame: After 3 months of training
Changes in the intestinal function
Neurogenic Bowel Dysfunction (NBD) score is used to evaluate intestinal function.
Time frame: After 6 months of training
Changes in the intestinal function
Neurogenic Bowel Dysfunction (NBD) score is used to evaluate intestinal function.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: After 6 months of training
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