NCT03967613

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Jun 2019

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 18, 2018

Completed
5 months until next milestone

First Posted

Study publicly available on registry

May 30, 2019

Completed
16 days until next milestone

Study Start

First participant enrolled

June 15, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2019

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 26, 2019

Completed
Last Updated

December 30, 2019

Status Verified

December 1, 2019

Enrollment Period

6 months

First QC Date

December 18, 2018

Last Update Submit

December 27, 2019

Conditions

Stroke

Keywords

Functional eletrical stimulationStrokeUpper limb

Outcome Measures

Primary Outcomes (1)

  • 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.

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

Secondary Outcomes (1)

  • User satisfaction

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

Study Arms (1)

FES

EXPERIMENTAL

Functional Eletrical Stimulation

Device: Functional eletrical stimulation

Interventions

Functional eletrical stimulationDEVICE

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

FES

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for Rehabilitation Research

Porto, 4200-072, Portugal

Location

Related Publications (1)

  • 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.

    PMID: 33253692DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Rubim Santos

Study Record Dates

First Submitted

December 18, 2018

First Posted

May 30, 2019

Study Start

June 15, 2019

Primary Completion

November 30, 2019

Study Completion

December 26, 2019

Last Updated

December 30, 2019

Record last verified: 2019-12

Locations

PT(1)