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Functional Eletrical Stimulation in Post Stroke Patients

NCT ID: NCT03967613

Last Updated: 2019-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-15

Study Completion Date

2019-12-26

Brief Summary

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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.

Detailed Description

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Conditions

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Stroke

Keywords

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Functional eletrical stimulation Stroke Upper limb

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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FES

Functional Eletrical Stimulation

Group Type EXPERIMENTAL

Functional eletrical stimulation

Intervention Type DEVICE

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

Interventions

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Functional eletrical stimulation

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundación General CSIC

UNKNOWN

Sponsor Role collaborator

Center for Rehabilitation Research (CIR)

UNKNOWN

Sponsor Role collaborator

Tecnalia

UNKNOWN

Sponsor Role collaborator

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

OTHER

Sponsor Role lead

Responsible Party

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Rubim Santos

Rubim Santos

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Center for Rehabilitation Research

Porto, , Portugal

Site Status

Countries

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Portugal

References

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Sousa ASP, Mesquita IA, Costa da Silva CI, Silva A, Macedo R, Imatz-Ojanguren E, Hernandez E, Keller T, Moreira J, Pereira da Fonseca PF, Santos R. Optimal Multifield Functional Electrical Stimulation Parameters for the "Turn on the Light" Task and Related Upper Limb Kinematics Repeatability in Poststroke Subjects. Arch Phys Med Rehabil. 2021 Jun;102(6):1180-1190. doi: 10.1016/j.apmr.2020.10.135. Epub 2020 Nov 27.

Reference Type DERIVED
PMID: 33253692 (View on PubMed)

Other Identifiers

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0348/CIE/ 6_E

Identifier Type: -

Identifier Source: org_study_id