Study of the Effectiveness of "Fesia Grasp": Functional Electrical Stimulation Device for Upper Limb Rehabilitation After Stroke (PI52021Rehab)

Study of the Effectiveness of Functional Electrical Stimulation Through the "Fesia Grasp" Device in the Rehabilitative Treatment of Patients With Affected Upper Limbs After a Stroke.

The purpose of this study is to evaluate the effectiveness of Fesia Grasp, a Functional Electrical Stimulation device for the rehabilitation of upper limb in post-stroke patients. 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: Recruiting
• Conditions: Stroke; Upper Extremity Paresis
• Intervention / Treatment: Device: Functional electrical stimulation through medical device; Other: Standard therapy

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fernando Mayordomo Riera, MD; Phone Number: 0034671596070; Email: uicec@imibic.org
• Study Contact Backup: Name: Silvia Guillén Climent; Email: silvia.guillen@imibic.org

Study Locations

• Spain
  • Córdoba, Spain, 14004
    • Recruiting
    • Hospital Universitario Reina Sofia
    • Contact: Fernando Mayordomo Riera, MD; Phone Number: 0034671596070; Email: uicec@imibic.org
    • Contact: Silvia Guillén Climent; Email: silvia.guillen@imibic.org
    • Principal Investigator: Fernando Mayordomo Riera, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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
• 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
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	Change from Baseline FMA scale at 6 weeks and 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medical Research Council (MRC)	A standardized assessment to measure muscle strength; Score range 0-5 (minimum 0, maximum 5)	Baseline; 6 weeks; 3 months
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
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
Euroqol-5d	Spanish version of the EuroQol-5D questionnaire (EQ-5D). It is a generic ABVD measurement instrument. The individual himself assesses his state of health, first in severity levels by five dimensions: mobility, personal care, daily activities, pain / discomfort and anxiety / depression.	6 weeks; 3 months
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
Adverse events	Any untoward medical occurrence during the clinical trial	Through study completion, an average of 6 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2022
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): September 1, 2022

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): March 4, 2022
• Last Update Submitted That Met QC Criteria: February 17, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Stroke; Functional Electrical Stimulation; Upper Extremity Paresis
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Stroke; Muscle Weakness; Paresis
• 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