TerminatedNot Applicable

Self-modulated Functional Electrical Stimulation in Chronic Stroke Patients With Severe and Moderate Upper Limb Paresis

Stopped: * Challenges experienced in recruitment. * Shifts in the sponsor's priorities and organizational structure resulting from its integration into a larger corporate group.

Switzerland29 participantsStarted 2019-11-08

Plain-language summary

The study aims at demonstrating the efficacy of self-modulated functional electrical stimulation (SM-FES) in promoting upper-limb (UL) motor recovery in chronic stroke patients with severe and severe-moderate paralysis. The effect of such experimental therapy will be compared to dose-matched, goal-oriented standard care (SC). SM-FES consists of intensive, goal-oriented, repetitive functional exercises assisted by electrical stimulation. The patient actively self-administers the electrical stimulation on the impaired limb by controlling the electrical stimulation device with the non-impaired hand. The duration of the intervention is 90 min per day, 5 days per week, for 2 weeks.

Who can participate

Age range

18 Years – 80 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: * diagnosis of one, first-ever ischemic stroke verified by brain imaging (i.e. computed tomography or magnetic resonance imaging); * chronic impairment after stroke, i.e. time since event ≥ 6months; * severe and severe-moderate upper limb impairment, i.e. FMA-UE score ≤ 34; * 18 ≤ age \< 80; * ability to give consent, understand the device use and follow instructions. Exclusion Criteria: * an unstable recovery stage, measured as a difference between screening and baseline examinations of more than 3 points in the motor part of the FMA-UE scale; * contraindications and risk factors to neuromuscular electrical stimulation; * severe hemi-spatial neglect or anosognosia involving the affected arm, as determined by the Bells tests (\> 6 errors); * severe impairment of proprioception, as evaluated from the blinded detection and discrimination of imposed passive movements (≥ 20° extension or flexion) of the finger proximal joint (\>3 errors out of 6 mobilisations); * severe impairment of tactile sensing in the hand, as assessed by Semmes-Weinstein monofilament test (no detection of the 5.88 size evaluator); * excessive spasticity, as indicated by a score \> 2 in any of the items of the REsistance to PASsive movement (REPAS) arm subtest; * recurrent, moderate to high upper limb pain limiting delivery of rehabilitation dose, i.e. pain at rest and in correspondence of a passive range of motion lower than 50%; * botulinum toxin injection into affected upper extremi…

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 the motor part of the Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) scale, calculated from baseline to post-intervention (2 weeks)

Timeframe: From baseline to post-intervention (2 weeks)

Trial details

NCT IDNCT04014270

SponsorIntento SA

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-10-26

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