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Completed

NCT Number: NCT06321172

Muscle and Bone Changes After 6 Months of FES Cycling

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.

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Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Scientific Institute, IRCCS E. Medea

Bosisio Parini, Lecco, 23842, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Critical osteoporosis
  • Skin lesions in interfaces parts with the trike,
  • Dysfunction of the autonomic nervous system, and
  • Psychopathological comorbidities

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Changes in the morpho-functional characteristics of the thigh muscles of the dominant limb

    Time frame: After 3 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.

  2. Changes in the morpho-functional characteristics of the thigh muscles of the dominant limb

    Time frame: One month after the end of the 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.

  3. Changes in bone quality

    Time frame: After 6 months of training

    The evaluation of improvements in the quality of the leg bones is performed with the Bone Mineral Density (BMD)

  4. Changes in data referring to the vegetative nervous system

    Time frame: After 3 months of training

    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.

  5. Changes in data referring to the vegetative nervous system

    Time frame: After 6 months of training

    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.

  6. Changes in data referring to the vegetative nervous system

    Time frame: One month after the end of the training

    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.

  7. Changes in the intestinal function

    Time frame: After 3 months of training

    Neurogenic Bowel Dysfunction (NBD) score is used to evaluate intestinal function.

  8. Changes in the intestinal function

    Time frame: After 6 months of training

    Neurogenic Bowel Dysfunction (NBD) score is used to evaluate intestinal function.

  9. Changes in the intestinal function

    Time frame: One month after the end of the training

    Neurogenic Bowel Dysfunction (NBD) score is used to evaluate intestinal function.

  10. Changes in the level of spasticity of the lower limbs

    Time frame: After 3 months of training

    To determine the level of spasticity in the lower limbs the Modified Ashworth scale (MAS) is used.

  11. Changes in the level of spasticity of the lower limbs

    Time frame: After 6 months of training

    To determine the level of spasticity in the lower limbs the Modified Ashworth scale (MAS) is used.

  12. Changes in the level of spasticity of the lower limbs

    Time frame: One month after the end of the training

    To determine the level of spasticity in the lower limbs the Modified Ashworth scale (MAS) is used.

  13. Changes in the level of pain perceived

    Time frame: After 3 months of training

    Numerical Rating Scale (NRS) to quantify the level of pain perceived by the subject.

  14. Changes in the level of pain perceived

    Time frame: After 6 months of training

    Numerical Rating Scale (NRS) to quantify the level of pain perceived by the subject.

  15. Changes in the level of pain perceived

    Time frame: One month after the end of the training

    Numerical Rating Scale (NRS) to quantify the level of pain perceived by the subject.

  16. Changes in the General Well Being of the pilots while training

    Time frame: After 3 months of 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.

  17. Changes in the General Well Being of the pilots while training

    Time frame: After 6 months of 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.

  18. Changes in the General Well Being of the pilots while training

    Time frame: One month after the end of the 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.

  19. Pilots' motivation in carrying out a sporting activity

    Time frame: After 3 months of training

    Sport Motivation Scale questionnaire is administered to evaluate the drivers' motivation in carrying out a sporting activity.

  20. Pilots' motivation in carrying out a sporting activity

    Time frame: After 6 months of training

    Sport Motivation Scale questionnaire is administered to evaluate the drivers' motivation in carrying out a sporting activity.

Sponsors and collaborators

Lead sponsor

IRCCS Eugenio Medea

Other

Collaborators

  • National Research Council
  • Politecnico di Milano
  • Villa Beretta Rehabilitation Center

Registry information

Official study 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

Acronym: FES-Bike

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 20, 2024
Registry last updated
Oct 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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