Muscle and Bone Changes After 6 Months of FES Cycling - Trial NCT06321172
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.
Study Focus
Sponsor & Location
IRCCS Eugenio Medea
Timeline & Enrollment
N/A
Sep 09, 2022
Apr 29, 2024
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
Data Source
ClinicalTrials.gov
NCT06321172
Device Trial