Functional Eletrical Stimulation in Post Stroke Patients

School of Allied Health Sciences of Porto (ESTSP) - Polytechnic Institute of Porto (IPP)14 enrolled

Overview

The FES-ABLE project results from an Iberian partnership and aims to evaluate the impact of an intervention based on a functional electrical stimulation (FES) prototype on the upper limb movement quality during functional tasks. The results of this project will contribute to the definition of the therapeutic window of FES to improve upper limb function in stroke rehabilitation.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Stroke

Interventions

Functional eletrical stimulationDEVICE

Aplication of functional eletrical stimulation on contralesional upper limb during functional tasks

Eligibility

Sex: ALLMin age: 30 Years

Medical Language ↔ Plain English

Inclusion Criteria: * First and unilateral ischemic or hemorrhagic stroke, in the middle cerebral artery, confirmed by imaging; * Age equal ou greater than 30 years old; * Preserved congnitive function, corresponding to a score higher than 23 in the Mini Mental State Examination (MMSE); * Ability to perform active movement in the contralesional upper limb (UL) of at least 15° in the shoulder and elbow. Exclusion Criteria: * Body mass index (BMI) less than 18,5 and greater than 30; * Hemi-spatial neglect and/or uncorrected visual changes; * Musculoskeletal or neurological conditions which may affect ULs and/or trunk function; * Pain in the ULs; * Severe sensorimotor impairment, corresponding to a score less than 39 in the Fugl-Meyer Assessment Scale - Upper Extremity (FMAS-UE); * Lesions on the skin of the affected forearm; * Severe spasticity (modified Ashworth \>3); * Severe muscle contractures on the affected forearm; * Pacemaker; * Osteosynthesis or metallic implants; * Pregnancy; * Adverse skin reaction to electrodes' gel.

Locations (1)

Center for Rehabilitation Research

Porto, Portugal

Outcomes

Primary Outcomes

Kinematic metrics change

End-point kinematics and joint kinematics will be analyzed. Regarding end-point kinematics, to evaluate speed, the absolute and relative movement times will be calculated separately for each phase and for the entire tasks, as well as the peak velocity for reach, forward and backward transport and return phases. To assess efficiency, smoothness and control strategy of movement, the índex of curvature, the number of velocity peaks (or number of motor units) and the time to peak velocity will be respectively calculated for reach, forward and backward transport and return phases. Regarding joint kinematics, joint angles5 of shoulder, elbow and wrist at onset of each phase will be calculated, as well as maximum aperture and time to maximum aperture in reach and return phases, and trunk displacement (to measure compensation) for each phase.

Time frame: Kinematic metrics will be assessed during 2 months and they will be reported through study completion, an average of 6 months

Secondary Outcomes

User satisfaction

Participants' satisfaction will be assessed through an adaptation of the Reduced Upper Extremity Motor Activity Log Questionnaire. In this adapted questionnaire, the participant will be asked to classify the use of the arm in function of the quantity (0 - not used;1 - very rarely; 2 - rarely; 3 -half pre-stroke; 4- 3/4 pre-stroke; 5 - same as pre-stroke.) and quality (0 - not used.1 - very poor.2 - poor.3 - fair.4 - almost normal.5 - normal.) in the evaluated tasks.

Time frame: User satisfaction will be assessed during 2 months and it will be reported through study completion, an average of 6 months

Data from ClinicalTrials.gov

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