Multi-field Functional Electrical Stimulation for Distal Upper-limb Rehabilitation After Subacute Stroke: a Pilot Randomised Controlled Trial (PI52021Rehab)

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Upper Extremity Paresis
• Intervention / Treatment: Device: Functional electrical stimulation through medical device; Other: Standard therapy

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Córdoba
    • Córdoba, Córdoba, Spain, 14004
      • Hospital Universitario Reina Sofía

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard Therapy	Other: Standard therapy; Physical therapy applied to the subject. Duration: 80 min twice a week, for 6 weeks.
Experimental: Functional Electrical Stimulation	Device: Functional electrical stimulation through medical device; The patient will receive a therapy with functional electrical stimulation. For this, a device called "Fesia Grasp" will be used. Duration: 80 min twice a week, for 6 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usability questionnaire specifically designed for this study	It consists of a 5 item questionnaire with five response options (Likert sacle); from Strongly agree to Strongly disagree. To evaluate the satisfaction of patients with the system and the therapy.	6 weeks
Intrinsic Motivation Inventory (IMI)	This scale is a multidimensional scale intended to assess participants subjective experience with the device (interest/enjoyment, perceived competence, effort, value/usefulness, felt pressure and tension, and perceived choice while performing a given activity). Consist of 20 item questionnaire with answers from 1 'strongly agree' to 7 'strongly disagree'	6 weeks
Adverse events	Any untoward medical occurrence during the clinical trial	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Ashworth Scale (MAS)	This scale measures resistance during passive soft-tissue stretching and is used as a simple measure of spasticity. It is single-item measures ranging from 0 to 4, where 0 indicates no increase in muscle tone and 4 indicates that the affected part is rigid in flexion or extension.	Baseline; 6 weeks; 3 months
Box & Blocks Test	It assesses unilateral gross manual dexterity. Individuals are seated at a table, facing a rectangular box that is divided into two square compartments of equal dimension by means of a partition. One hundred and fifty, 2.5 cm, colored, wooden cubes or blocks are placed in one compartment or the other. The test is scored by counting the number of blocks carried over the partition from one compartment to the other during the one-minute trial period.	Baseline; 6 weeks; 3 months
Motor Activity Log (MAL)	Semi-structured interview to assess arm function. Individuals are asked to rate Quality of Movement and Amount of Movement during 30 daily functional tasks. Target tasks include object manipulation (e.g. pen, fork, comb, and cup) as well as the use of the arm during gross motor activities (e.g. transferring to a car, steadying oneself during standing, pulling a chair into a table while sitting).	Baseline; 6 weeks; 3 months
Fugl-Meyer Assessment (FMA) scale	It is an index to assess the sensorimotor impairment in individuals who have had stroke. The Fugl-Meyer Assessment scale is an ordinal scale that has 3 points for each item. A zero score is given for the item if the subject cannot do the task. A score of 1 is given when the task is performed partially and a score of 2 is given when the task is performed fully. The maximun score is 66 points	6 weeks

Collaborators and Investigators

• Sponsor: Maimónides Biomedical Research Institute of Córdoba
• Collaborators: FESIA Technology
• Investigators: Principal Investigator: Fernando Mayordomo Riera, MD, Hospital General Universitario Reina Sofía de Murcia

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2022
• Primary Completion (Actual): August 1, 2023
• Study Completion (Actual): December 1, 2023

Study Registration Dates

• First Submitted: July 16, 2021
• First Submitted That Met QC Criteria: August 4, 2021
• First Posted (Actual): August 5, 2021

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Stroke; Functional Electrical Stimulation; Upper Extremity Paresis
• Additional Relevant MeSH Terms: Neurologic Manifestations; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Stroke; Paresis; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: PI52021Rehab

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The results will be available for other investigators.
• IPD Sharing Time Frame: Once the trial is ended and the result are published in a paper.
• IPD Sharing Access Criteria: Upon request to silvia.guillen@imibic.org
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No