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NCT04992910Completed

Multi-field Functional Electrical Stimulation for Distal Upper-limb Rehabilitation After Subacute Stroke: a Pilot Randomised Controlled Trial

Source: ClinicalTrials.gov · Last updated 27 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
16 (actual)
First submitted
16 Jul 2021
Start date
14 Feb 2022
Primary completion date
1 Aug 2023
Lead sponsor
Maimónides Biomedical Research Institute of Córdoba
Diseases
Stroke
NCT number
NCT04992910

What you commit to

  • Study type: Interventional
  • Participants enrolled: 16
  • From 14 Feb 2022 to the primary completion date, 1 Aug 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Psychiatric illness (including post-stroke depression).
  • Cognitive impairment.

Other

  • Very severe proximal spasticity: Ashworth \> 3.
  • 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.

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hospital Universitario Reina Sofia
Coordinator of this site? Confirm its status
CórdobaSpainUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.