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NCT06321172Recruitment Completed

Muscle and Bone Changes After 6 Months of FES Cycling

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
IRCCS Eugenio MedeaClinicalTrials.govdeviceDevice trial
Study focus
Disease/Condition
Spinal Cord Injuries
Drug/Device/Intervention
FES Bike
Study type
Interventional
Intervention type
device
Sponsor & location
Primary sponsor
IRCCS Eugenio Medea
Location
Bosisio Parini, Italy
Timeline & enrollment
Phase
N/A
Start date
Sep 09, 2022
End date
Apr 29, 2024
Enrollment
5 participants
Primary outcome

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

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.

ICD-10 classifications
Sequelae of injury of spinal cordOther and unspecified injuries of thoracic spinal cordOther and unspecified injuries of cervical spinal cordOther injury of lumbar spinal cordInjury of spinal cord, level unspecified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06321172
Type
Device Trial
About this record

Access comprehensive clinical trial information for NCT06321172 through Pure Global AI's free database. This phase not specified trial is sponsored by IRCCS Eugenio Medea and is currently Recruitment Completed. The study focuses on Spinal Cord Injuries. Target enrollment is 5 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.