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Recumbent Cycling and Functional Electrical Stimulation for Lower Limb Rehabilitation

Study acronym: BiciFES
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
This study evaluates two different control strategies for a rehabilitation device that combines recumbent leg-cycling with functional electrical stimulation (FES) of the quadriceps muscle. The device assists pedaling using a motor and electrical stimulation, and is intended for use after knee surgery (such as ACL reconstruction) or in other lower-limb rehabilitation. During muscle stimulation, fatigue can develop, which reduces the force produced by the stimulated muscle. This study compares a standard control strategy with a new strategy that adjusts stimulation based on the muscle's fatigue level, measured in real time. Healthy adult volunteers will complete two sessions on a recumbent stationary bicycle, 2 to 7 days apart. Each session lasts about 60 minutes and includes periods of pedaling with electrical stimulation, as well as isometric wall squats to induce muscle fatigue. Muscle activity, pedal force, and pedal position will be recorded throughout. The goal is to determine which control strategy produces more mechanical work from the leg muscles and better tracks the desired pedaling pattern, especially as fatigue develops.
Trial Details
NCT Number NCT07873424
Lead Sponsor National Council of Scientific and Technical Research, Argentina
Conditions
(from sponsor)
Muscle Fatigue, Functional Electrical Stimulation, Neuromuscular Rehabilitation
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov