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Completed

NCT Number: NCT03967613

Functional Eletrical Stimulation in Post Stroke Patients

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Rehabilitation Research

Porto, 4200-072, Portugal

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Functional eletrical stimulation

Device

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

Primary outcomes

  1. Kinematic metrics change

    Time frame: 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 outcomes

  1. User satisfaction

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Center for Rehabilitation Research (CIR)
  • Fundación General CSIC
  • Tecnalia

Registry information

Official study title

Impact of an Intervention Based on a Multichannel Functional Electrical Stimulation (FES) Prototype on the Upper Limb Movement Quality in Post Stroke Patients

Acronym: FES-ABLE

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 30, 2019
Registry last updated
Dec 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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