Muscle and Bone Changes After 6 Months of FES Cycling (FES-Bike)

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.

Study Overview

• Status: Completed
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Device: FES Bike

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 Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Lecco
    • Bosisio Parini, Lecco, Italy, 23842
      • Scientific Institute, IRCCS E. Medea

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: FES cycling group; Six months of FES-cycling trainings twice a week were performed for each pilot. Each session includes at most 30 minutes of stimulation.

Device: FES Bike; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: IRCCS Eugenio Medea
• Collaborators: Politecnico di Milano; Villa Beretta Rehabilitation Center; National Research Council

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2022
• Primary Completion (Actual): January 22, 2024
• Study Completion (Actual): April 29, 2024

Study Registration Dates

• First Submitted: March 14, 2024
• First Submitted That Met QC Criteria: March 14, 2024
• First Posted (Actual): March 20, 2024

Study Record Updates

• Last Update Posted (Actual): October 8, 2024
• Last Update Submitted That Met QC Criteria: October 3, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Spinal Cord Injury; FES; FES cycling
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: 785

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No