CompletedNot Applicable

Efficacy Study of FES Controlled by Electromyographic Signal for the Treatment of Upper Limb in Post-stroke Patients

82 participantsStarted 2011-04

Plain-language summary

Goal of the present study is to evaluate the efficacy of Myoelectrically-controlled Functional Electrical Stimulation (MeCFES) for the rehabilitation of upper limb in post-stroke patients. MeCFES-assisted rehabilitation will be compared with usual care rehabilitation of upper limb. It is hypothesized that that applying MeCFES in rehabilitation to assist normal arm movements during rehabilitation of the upper limb in persons with stroke will improve the movement quality and success and thus induce recovery at the body functions level (impairment) and the activity level (disability) of the International Classification of Function (ICF) superior to that induced by usual care rehabilitation.

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: * Hemiplegia/hemiparesis due to a first ischemic or haemorrhagic stroke * at least 1 month post-stroke * willingness to participate the project * minimum voluntary muscle activation of shoulder flexors (\>1 Manual Muscle Test) * passive Range of Motion (ROM) of the shoulder and elbow of more than 90° Exclusion Criteria: * epilepsy * severe spasticity at upper limb (\>= 3 Ashworth scale) * implanted electronic device * respiratory insufficiency * pregnancy * peripheral neuropathies * cutaneous ulcers at the stimulation zone * other use of FES on the upper limb

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 Score of ARAT Scale Between Two Time Points: Post-treatment vs Pre-treatment

Timeframe: 5 weeks (post-treatment vs pre-treatment)

Change Score of FMA-UE Scale Between Two Time Points: Post-treatment vs Pre-treatment

Timeframe: 5 weeks (post-treatment vs pre-treatment)

Trial details

NCT IDNCT03019744

SponsorFondazione Don Carlo Gnocchi Onlus

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-11

Results submitted2018-08-03

View on ClinicalTrials.gov More Stroke trials