Clinical trial NCT03967613: Functional Eletrical Stimulation in Post Stroke Patients
Official title: Impact of an Intervention Based on a Multichannel Functional Electrical Stimulation (FES) Prototype on the Upper Limb Movement Quality in Post Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Functional eletrical stimulation
Stroke
Upper limb
Lead sponsor: School of Allied Health Sciences of Porto (ESTSP) - Polytechnic Institute of Porto (IPP)
Sponsor class: OTHER
Collaborators: name: Fundación General CSIC
name: Center for Rehabilitation Research (CIR)
name: Tecnalia
First posted: 2019-05-30
Enrollment: 14
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Kinematic metrics change
timeFrame: Kinematic metrics will be assessed during 2 months and they will be reported through study completion, an average of 6 months
Secondary outcomes:
measure: User satisfaction
timeFrame: User satisfaction will be assessed during 2 months and it will be reported through study completion, an average of 6 months
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Center for Rehabilitation Research
Study officials:
References:
citation: 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.