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Transcranial Direct Current Stimulation and Functional Electrical Stimulation for Upper-limb Rehabilitation After Stroke

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Functional Electrical Stimulation (FES)
Combination of Transcranial direct brain stimulation (tDCS) and FES
Sponsored by
Federal University of Health Science of Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Cerebrovascular Accident, Cerebrovascular Stroke, Cerebral Stroke

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Federal University of Health Sciences of Porto Alegre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Functional electrical stimulation (FES)

Combination of transcranial direct current stimulation and FES

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Grip force assessed by means of dynamometer
Evaluated by means of dynamometer (Jamar)
Manual dexterity assessed by means of the block and box test
Block and box test
Quality of life assessed by means of the Stroke-Specific Quality of Life (SSQOL)
Questionnaire
Muscular tone assessed by the Modified Ashworth Scale
Modified Ashworth Scale
Assessment of Sensorimotor Recovery After Stroke by the Fugl-Meyer scale
Fugl-Meyer scale

Full Information

First Posted
November 2, 2015
Last Updated
June 12, 2019
Sponsor
Federal University of Health Science of Porto Alegre
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1. Study Identification

Unique Protocol Identification Number
NCT02818608
Brief Title
Transcranial Direct Current Stimulation and Functional Electrical Stimulation for Upper-limb Rehabilitation After Stroke
Official Title
Association Between the Transcranial Direct Current Stimulation (tDCS) and Functional Electrical Stimulation (FES) for Upper-limb Rehabilitation After Stroke - A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
August 14, 2017 (Actual)
Primary Completion Date
August 13, 2018 (Actual)
Study Completion Date
January 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Health Science of Porto Alegre

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Cerebrovascular Accident, Cerebrovascular Stroke, Cerebral Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Functional electrical stimulation (FES)
Arm Type
Active Comparator
Arm Description
Chronic stroke patients submitted to functional electrical stimulation (FES).
Arm Title
Combination of transcranial direct current stimulation and FES
Arm Type
Experimental
Arm Description
Chronic stroke patients submitted to transcranial direct current stimulation (tDCS) and functional and to functional electrical stimulation (FES).
Intervention Type
Device
Intervention Name(s)
Functional Electrical Stimulation (FES)
Intervention Description
Functional Electrical Stimulation (FES) + Sham Transcranial direct brain stimulation (tDCS)
Intervention Type
Device
Intervention Name(s)
Combination of Transcranial direct brain stimulation (tDCS) and FES
Intervention Description
Real Functional Electrical Stimulation (FES) + Real Transcranial direct brain stimulation (tDCS)
Primary Outcome Measure Information:
Title
Upper-limb reaching analysis evaluated by means of the 3-D motion analysis system (BTS SMART DX 400)
Description
3-D motion analysis system
Time Frame
Change from Pre to Post 1 (after the 10th session) and Post 3 (3 months follow-up)
Secondary Outcome Measure Information:
Title
Grip force assessed by means of dynamometer
Description
Evaluated by means of dynamometer (Jamar)
Time Frame
Change from Pre to Post 1 (after the 10th session) and Post 3 (3 months follow-up)
Title
Manual dexterity assessed by means of the block and box test
Description
Block and box test
Time Frame
Change from Pre to Post 1 (after the 10th session) and Post 3 (3 months follow-up)
Title
Quality of life assessed by means of the Stroke-Specific Quality of Life (SSQOL)
Description
Questionnaire
Time Frame
Change from Pre to Post 1 (after the 10th session) and Post 3 (3 months follow-up)
Title
Muscular tone assessed by the Modified Ashworth Scale
Description
Modified Ashworth Scale
Time Frame
Change from Pre to Post 1 (after the 10th session) and Post 3 (3 months follow-up)
Title
Assessment of Sensorimotor Recovery After Stroke by the Fugl-Meyer scale
Description
Fugl-Meyer scale
Time Frame
Change from Pre to Post 1 (after the 10th session) and Post 3 (3 months follow-up)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
Federal University of Health Sciences of Porto Alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
31158553
Citation
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.
Results Reference
derived

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Transcranial Direct Current Stimulation and Functional Electrical Stimulation for Upper-limb Rehabilitation After Stroke

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