Recumbent cycling with FES for leg rehabilitation after knee surgery
Official title: Rehabilitation Mechanisms Based on Recumbent Pedaling and Functional Electrical Stimulation
Run by National Council of Scientific and Technical Research, Argentina · NCT07873424 · Data updated 2026-11-12
This study tests two control methods for a device that combines recumbent cycling with electrical stimulation of the thigh muscle to help lower-limb rehab in healthy adults first and see how fatigue-aware control compares to standard control.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 60 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | National Council of Scientific and Technical Research, Argentina Government |
| Locations | 1 site (Oro Verde, Entre Ríos Province) |
| Status | Recruiting |
| Started | August 20, 2026 |
| Main results expected | October 30, 2026 |
| Study ends | November 30, 2026 |
| Registry record updated | October 14, 2026 |
| Trial ID | NCT07873424 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Healthy adults aged 18–60 without lower-limb injuries or conditions affecting movement, who can consent and comply with study procedures.
✕Probably not a fit
Individuals with recent lower-limb surgery or conditions with contraindications to FES or intense lower-limb activity may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Participants will undergo two visits (2–7 days apart) in a randomized crossover design to compare fatigue-aware FES control versus standard FES control during pedaling on a custom recumbent bike. The setup includes a motor-assisted pedal system, force and position sensors, and a 16-channel EMG system to monitor muscle activity. Each session features calibration, an FES-assisted pedaling block, a fatigue-induction task (wall squats), and a second FES-assisted pedaling block. Primary outcome is mechanical work during stimulated pedaling; secondary outcomes include pedal force, EMG RMS, estimated muscle fatigue, and cadence-tracking error. The study is conducted at the Biomechanics Laboratory, Universidad Nacional de Entre Ríos, Argentina, with adult participants aged 18–60 who meet safety criteria.
Why it matters
Potential benefit: If fatigue-aware stimulation proves superior, patients could experience more effective rehabilitation with better sustained pedal effort.
How similar studies have gone: Previous work in FES-assisted cycling has demonstrated feasibility; this study adds fatigue-responsive control in a crossover design.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age between 18 and 60 years. * Body weight less than 120 kg. * No injuries or conditions affecting the osteoarticular or musculoskeletal system. * No strenuous physical exertion of the lower limb within the previous 24 hours. * Willingness and ability to understand the content and scope of the experiment and to comply with its instructions. * Signed informed consent. Exclusion Criteria: * Pregnancy. * History of chronic pain, neuromuscular disorders, or lower-limb surgical interventions without medical clearance. * Use of analgesics within 24 hours prior to participation. * Lack of cooperation. * Trauma to the segment under evaluation within the previous 4 weeks.
Where it's running
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Facultad de Ingeniería - Universidad Nacional de Entre Ríos
Oro Verde, Entre Ríos Province, Argentina Recruiting
Study contacts
- Study coordinator: Carolina Chaves García, MSc
- Email: carolina.chaves@uner.edu.ar
- Phone: (+54) 343 4975100
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.