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

S

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

Status

Completed

Conditions

Stroke

Treatments

Device: Functional eletrical stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT03967613
0348/CIE/ 6_E

Details and patient eligibility

About

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.

Enrollment

14 patients

Sex

All

Ages

30+ years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

14 participants in 1 patient group

FES
Experimental group
Description:
Functional Eletrical Stimulation
Treatment:
Device: Functional eletrical stimulation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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