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

NCT04992910 | Unknown

• 1 other identifier: PI52021Rehab
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke; Upper Extremity Paresis

Keywords

Stroke; Upper Extremity Paresis; Functional Electrical Stimulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Medical Research Council (MRC)

  Baseline; 6 weeks; 3 months

• 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

• Intrinsic Motivation Inventory (IMI)

  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
• FESIA Technology: collaborator

Study Sites (1)

Hospital Universitario Reina Sofía

Córdoba, 14004, Spain

RECRUITING

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 Universitario Reina Sofía

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fernando Mayordomo Riera, MD

CONTACT

0034671596070; uicec@imibic.org

Silvia Guillén Climent

CONTACT

silvia.guillen@imibic.org

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: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: March 4, 2022

Record last verified: 2022-02

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)