FES-ABLE: Functional Eletrical Stimulation in Post Stroke Patients

Sponsor

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

Overall Status

Completed

CT.gov ID

NCT03967613

Collaborator

Fundación General CSIC (Other), Center for Rehabilitation Research (CIR) (Other), Tecnalia (Other)

Enrollment

Location

Arm

6.4

Actual Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Device: Functional eletrical stimulation	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

14 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jun 15, 2019

Actual Primary Completion Date :

Nov 30, 2019

Actual Study Completion Date :

Dec 26, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: FES Functional Eletrical Stimulation	Device: Functional eletrical stimulation Aplication of functional eletrical stimulation on contralesional upper limb during functional tasks

Arm

Intervention/Treatment

Experimental: FES

Functional Eletrical Stimulation

Device: Functional eletrical stimulation

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

Outcome Measures

Primary Outcome Measures

Kinematic metrics change [Kinematic metrics will be assessed during 2 months and they will be reported through study completion, an average of 6 months]
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.

Secondary Outcome Measures

User satisfaction [User satisfaction will be assessed during 2 months and it will be reported through study completion, an average of 6 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Center for Rehabilitation Research	Porto		Portugal	4200-072

Sponsors and Collaborators

School of Allied Health Sciences of Porto (ESTSP) - Polytechnic Institute of Porto (IPP)
Fundación General CSIC
Center for Rehabilitation Research (CIR)
Tecnalia

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rubim Santos, Rubim Santos, Polytechnic Institute of Porto

ClinicalTrials.gov Identifier:

NCT03967613

Other Study ID Numbers:

0348/CIE/ 6_E

First Posted:

May 30, 2019

Last Update Posted:

Dec 30, 2019

Last Verified:

Dec 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Rubim Santos, Rubim Santos, Polytechnic Institute of Porto

Functional eletrical stimulation

Stroke

Upper limb

Additional relevant MeSH terms:

Stroke

Study Results

No Results Posted as of Dec 30, 2019