Clinical trial NCT02818608: 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
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Cerebrovascular Accident
Cerebrovascular Stroke
Cerebral Stroke
Lead sponsor: Federal University of Health Science of Porto Alegre
Sponsor class: OTHER
First posted: 2016-06-30
Enrollment: 51
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Upper-limb reaching analysis evaluated by means of the 3-D motion analysis system (BTS SMART DX 400)
timeFrame: Change from Pre to Post 1 (after the 10th session) and Post 3 (3 months follow-up)
Secondary outcomes:
measure: Grip force assessed by means of dynamometer
timeFrame: Change from Pre to Post 1 (after the 10th session) and Post 3 (3 months follow-up)
measure: Manual dexterity assessed by means of the block and box test
timeFrame: Change from Pre to Post 1 (after the 10th session) and Post 3 (3 months follow-up)
measure: Quality of life assessed by means of the Stroke-Specific Quality of Life (SSQOL)
timeFrame: Change from Pre to Post 1 (after the 10th session) and Post 3 (3 months follow-up)
measure: Muscular tone assessed by the Modified Ashworth Scale
timeFrame: Change from Pre to Post 1 (after the 10th session) and Post 3 (3 months follow-up)
measure: Assessment of Sensorimotor Recovery After Stroke by the Fugl-Meyer scale
timeFrame: Change from Pre to Post 1 (after the 10th session) and Post 3 (3 months follow-up)
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Federal University of Health Sciences of Porto Alegre
state: Rio Grande Do Sul
Study officials:
References:
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.