NCT02818608

Brief Summary

The aim of this study is to verify the effectiveness of tDCS combined with FES on upper limb rehabilitation of post-stroke subjects with moderate and severe compromise.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started Aug 2017

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

November 2, 2015

Completed
8 months until next milestone

First Posted

Study publicly available on registry

June 30, 2016

Completed
1.1 years until next milestone

Study Start

First participant enrolled

August 14, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 13, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2019

Completed
Last Updated

June 13, 2019

Status Verified

June 1, 2019

Enrollment Period

12 months

First QC Date

November 2, 2015

Last Update Submit

June 12, 2019

Conditions

Stroke

Keywords

Cerebrovascular AccidentCerebrovascular StrokeCerebral Stroke

Outcome Measures

Primary Outcomes (1)

  • Upper-limb reaching analysis evaluated by means of the 3-D motion analysis system (BTS SMART DX 400)

    3-D motion analysis system

    Change from Pre to Post 1 (after the 10th session) and Post 3 (3 months follow-up)

Secondary Outcomes (5)

  • Grip force assessed by means of dynamometer

    Change from Pre to Post 1 (after the 10th session) and Post 3 (3 months follow-up)

  • Manual dexterity assessed by means of the block and box test

    Change from Pre to Post 1 (after the 10th session) and Post 3 (3 months follow-up)

  • Quality of life assessed by means of the Stroke-Specific Quality of Life (SSQOL)

    Change from Pre to Post 1 (after the 10th session) and Post 3 (3 months follow-up)

  • Muscular tone assessed by the Modified Ashworth Scale

    Change from Pre to Post 1 (after the 10th session) and Post 3 (3 months follow-up)

  • Assessment of Sensorimotor Recovery After Stroke by the Fugl-Meyer scale

    Change from Pre to Post 1 (after the 10th session) and Post 3 (3 months follow-up)

Study Arms (2)

Functional electrical stimulation (FES)

ACTIVE COMPARATOR

Chronic stroke patients submitted to functional electrical stimulation (FES).

Device: Functional Electrical Stimulation (FES)

Combination of transcranial direct current stimulation and FES

EXPERIMENTAL

Chronic stroke patients submitted to transcranial direct current stimulation (tDCS) and functional and to functional electrical stimulation (FES).

Device: Combination of Transcranial direct brain stimulation (tDCS) and FES

Interventions

Functional Electrical Stimulation (FES)DEVICE

Functional Electrical Stimulation (FES) + Sham Transcranial direct brain stimulation (tDCS)

Functional electrical stimulation (FES)
Combination of Transcranial direct brain stimulation (tDCS) and FESDEVICE

Real Functional Electrical Stimulation (FES) + Real Transcranial direct brain stimulation (tDCS)

Combination of transcranial direct current stimulation and FES

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects with ischemic or hemorrhagic stroke diagnosis and moderate or severe hemiparesis (chronic stroke - at least 6 months of disease)
  • Ability to reach 60 degrees in the shoulder flexion
  • Minimal cognitive ability to understand commands
  • No current use of antiepileptic drugs for seizures

You may not qualify if:

  • Painful shoulder, adhesive capsulitis or glenohumeral subluxation
  • Contraindication for electrical stimulation (presence of metallic implants) or risks for the tDCS, as evaluated by means of a standard questionnaire

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Health Sciences of Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Location

Related Publications (1)

  • Salazar AP, Cimolin V, Schifino GP, Rech KD, Marchese RR, Pagnussat AS. Bi-cephalic transcranial direct current stimulation combined with functional electrical stimulation for upper-limb stroke rehabilitation: A double-blind randomized controlled trial. Ann Phys Rehabil Med. 2020 Jan;63(1):4-11. doi: 10.1016/j.rehab.2019.05.004. Epub 2019 May 31.

    PMID: 31158553DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

November 2, 2015

First Posted

June 30, 2016

Study Start

August 14, 2017

Primary Completion

August 13, 2018

Study Completion

January 15, 2019

Last Updated

June 13, 2019

Record last verified: 2019-06

Locations

BR(1)