Multi-field Functional Electrical Stimulation for Distal Upper-limb Rehabilitation After Subacute… (NCT04992910) | Clinical Trial Compass
CompletedNot Applicable
Multi-field Functional Electrical Stimulation for Distal Upper-limb Rehabilitation After Subacute Stroke: a Pilot Randomised Controlled Trial
Spain16 participantsStarted 2022-02-14
Plain-language summary
The purpose of this study is to evaluate the feasibility, usability, and safety of multi-field FES-assisted therapy for hand rehabilitation in individuals with subacute stroke. A secondary, exploratory objective is to estimate preliminary effect sizes for distal upper-limb motor outcomes to inform the design of future adequately powered trials.
Fesia Grasp rehabilitation will be compared with usual care rehabilitation of upper limb.
* Experimental group: patients will receive Fesia Grasp therapy (intensive, repetitive and functional exercises assisted by functional electrical stimulation)
* Control group - patients will receive standard care.
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:
* 18 years old or older subjects with hemiparesis in the upper limb after stroke, which have been referred to the Rehabilitation Unit of the Reina University Hospital.
* Unilateral paresis
* Cognitive ability to assimilate and actively participate in the protocol of evaluation and treatment
Exclusion Criteria:
* Very severe proximal spasticity: Ashworth \> 3.
* Psychiatric illness (including post-stroke depression).
* Cognitive impairment.
* Inability to provide informed consent.
* Other severe medical problems.
* Severe hemi-spatial neglect or anosognosia involving the affected arm.
* Pacemakers
* Pregnant women.
* Skin ulcers.
* Peripheral neuropathies.
* Edema of the affected forearm and / or hand.
* Severe pain.
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
1
Intrinsic Motivation Inventory (IMI)
Timeframe: 6 weeks
2
Adverse events
Timeframe: 6 weeks
3
Usability questionnaire specifically designed for this study
Timeframe: 6 weeks
Trial details
NCT IDNCT04992910
SponsorMaimónides Biomedical Research Institute of Córdoba