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Functional Eletrical Stimulation in Post Stroke Patients (FES-ABLE)

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Functional eletrical stimulation
Sponsored by
School of Allied Health Sciences of Porto (ESTSP) - Polytechnic Institute of Porto (IPP)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Functional eletrical stimulation, Stroke, Upper limb

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Center for Rehabilitation Research

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FES

Arm Description

Functional Eletrical Stimulation

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
December 18, 2018
Last Updated
December 27, 2019
Sponsor
School of Allied Health Sciences of Porto (ESTSP) - Polytechnic Institute of Porto (IPP)
Collaborators
Fundación General CSIC, Center for Rehabilitation Research (CIR), Tecnalia
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1. Study Identification

Unique Protocol Identification Number
NCT03967613
Brief Title
Functional Eletrical Stimulation in Post Stroke Patients
Acronym
FES-ABLE
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

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
June 15, 2019 (Actual)
Primary Completion Date
November 30, 2019 (Actual)
Study Completion Date
December 26, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
School of Allied Health Sciences of Porto (ESTSP) - Polytechnic Institute of Porto (IPP)
Collaborators
Fundación General CSIC, Center for Rehabilitation Research (CIR), Tecnalia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Functional eletrical stimulation, Stroke, Upper limb

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FES
Arm Type
Experimental
Arm Description
Functional Eletrical Stimulation
Intervention Type
Device
Intervention Name(s)
Functional eletrical stimulation
Intervention Description
Aplication of functional eletrical stimulation on contralesional upper limb during functional tasks
Primary Outcome Measure Information:
Title
Kinematic metrics change
Description
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 Outcome Measure Information:
Title
User satisfaction
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Center for Rehabilitation Research
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal

12. IPD Sharing Statement

Citations:
PubMed Identifier
33253692
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.
Results Reference
derived

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Functional Eletrical Stimulation in Post Stroke Patients

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