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

NCT04992910 | Completed

• 1 other identifier: PI52021Rehab
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke; Upper Extremity Paresis

Keywords

Stroke; Upper Extremity Paresis; Functional Electrical Stimulation

Outcome Measures

Primary Outcomes (3)

• 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

• 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

Secondary Outcomes (4)

• Modified Ashworth Scale (MAS)

  Baseline; 6 weeks; 3 months

• Box & Blocks Test

  Baseline; 6 weeks; 3 months

• Motor Activity Log (MAL)

  Baseline; 6 weeks; 3 months

• Fugl-Meyer Assessment (FMA) scale

  6 weeks

Study Arms (2)

Functional Electrical Stimulation

EXPERIMENTAL

Device: Functional electrical stimulation through medical device

Standard Therapy

ACTIVE COMPARATOR

Other: Standard therapy

Interventions

Functional electrical stimulation through medical device 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.

Functional Electrical Stimulation

Standard therapy OTHER

Physical therapy applied to the subject. Duration: 80 min twice a week, for 6 weeks.

Standard Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Maimónides Biomedical Research Institute of Córdoba: lead

Study Sites (1)

Hospital Universitario Reina Sofía

Córdoba, Córdoba, 14004, Spain

Location

MeSH Terms

Conditions

Stroke; Paresis

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Fernando Mayordomo Riera, MD

  Hospital General Universitario Reina Sofía de Murcia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2021
• First Posted: August 5, 2021
• Study Start: February 14, 2022
• Primary Completion: August 1, 2023
• Study Completion: December 1, 2023
• Last Updated: May 27, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Once the trial is ended and the result are published in a paper.
• Access Criteria: Upon request to silvia.guillen@imibic.org

Locations

ES (1)