Muscle and Bone Changes After 6 Months of FES Cycling

NCT06321172 | Completed

• 1 other identifier: 785
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Spinal Cord Injuries

Keywords

Spinal Cord Injury; FES; FES cycling

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (20)

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

  After 3 months of training

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

  One month after the end of the training

• Changes in bone quality

  After 6 months of training

• Changes in data referring to the vegetative nervous system

  After 3 months of training

• Changes in data referring to the vegetative nervous system

  After 6 months of training

Study Arms (1)

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.

Device: FES Bike

Interventions

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.

FES cycling group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS Eugenio Medea: lead
• Politecnico di Milano: collaborator
• Villa Beretta Rehabilitation Center: collaborator
• National Research Council: collaborator

Study Sites (1)

Scientific Institute, IRCCS E. Medea

Bosisio Parini, Lecco, 23842, Italy

Location

Related Publications (1)

• 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.

  PMID: 40065341 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2024
• First Posted: March 20, 2024
• Study Start: September 9, 2022
• Primary Completion: January 22, 2024
• Study Completion: April 29, 2024
• Last Updated: October 8, 2024

Record last verified: 2024-10

Locations

IT (1)