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

NCT ID: NCT04992910

Last Updated: 2022-03-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-14
• Study Completion Date: 2022-09-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Functional Electrical Stimulation

Group Type: EXPERIMENTAL

Functional electrical stimulation through medical device

Intervention Type: 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.

Standard Therapy

Group Type: ACTIVE_COMPARATOR

Standard therapy

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: DEVICE

Standard therapy

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

FESIA Technology

UNKNOWN

Sponsor Role: collaborator

Maimónides Biomedical Research Institute of Córdoba

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fernando Mayordomo Riera, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Reina Sofía

Locations

Hospital Universitario Reina Sofía

Córdoba, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Fernando Mayordomo Riera, MD

Role: CONTACT

uicec@imibic.org

0034671596070

Silvia Guillén Climent

Role: CONTACT

silvia.guillen@imibic.org

Facility Contacts

Fernando Mayordomo Riera, MD

Role: primary

uicec@imibic.org

0034671596070

Silvia Guillén Climent

Role: backup

silvia.guillen@imibic.org

Other Identifiers

PI52021Rehab

Identifier Type: -

Identifier Source: org_study_id