UnknownNot Applicable

Pilot Study for Peripheral Neuromuscular Electrical Stimulation of the Quadriceps Muscle

Brazil15 participantsStarted 2023-06-01

Plain-language summary

Feasibility study of a new medical device that will evaluate the usability and effectiveness of a cycle ergometer device associated with neuromuscular electrical stimulation (FES cycling). The study's objective is to evaluate the effect of the application of functional electrical stimulation of the new device on participants' quadriceps muscle strength in comparison to a medical device with similar characteristics and to a control group. Secondarily, the study will compare the usability of the two medical devices as evaluated by the participants and the therapists who apply the treatment, as well as the participants' satisfaction with the treatment, identifying possible adverse effects.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Spinal cord injury, brain injury or acquired muscle weakness * Managed chronic diseases * No contraindications to the practice of physical exercise * Ability to communicate in oral and written Portuguese Exclusion Criteria: * Amputation of lower limbs at any level * Unstable or acute fractures of lower limbs * Contraindication for the practice of physical activity * Open wounds in the lower limbs * Consent withdraw

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in knee joint extensors peak torque (Newton-Meters)

Timeframe: Change from baseline knee joint extensors peak torque at end of intervention, completed 8 weeks after initiation

Change in knee joint flexors peak torque (Newton-Meters)

Timeframe: Change from baseline knee joint flexors peak torque at end of intervention, completed 8 weeks after initiation

Change in thigh perimeter (centimeters)

Timeframe: Change from baseline thigh perimeter at end of intervention, completed 8 weeks after initiation

Change in rectus femoris thickness (centimeters)

Timeframe: Change from baseline rectus femoris thickness at end of intervention, completed 8 weeks after initiation

Change in vastus intermedius thickness (centimeters)

Timeframe: Change from baseline vastus intermedius thickness at end of intervention, completed 8 weeks after initiation

Trial details

NCT IDNCT05888714

SponsorUniversity of Sao Paulo General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-09-01

Contact for this trial

André T. Sugawara, MD, PhD

55-11-5180-7897 andre.sugawara@hc.fm.usp.br

View on ClinicalTrials.gov More Spinal Cord Injuries trials