NCT02818608CompletedNot Applicable
Association Between the Transcranial Direct Current Stimulation (tDCS) and Functional Electrical Stimulation (FES) for Upper-limb Rehabilitation After Stroke - A Randomized Clinical Trial
Federal University of Health Science of Porto Alegre1 site in 1 country51 target enrollmentStarted: August 14, 2017Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 51
- Locations
- 1
- Primary Endpoint
- Upper-limb reaching analysis evaluated by means of the 3-D motion analysis system (BTS SMART DX 400)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 30 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Upper-limb reaching analysis evaluated by means of the 3-D motion analysis system (BTS SMART DX 400)
Time Frame: Change from Pre to Post 1 (after the 10th session) and Post 3 (3 months follow-up)
3-D motion analysis system
Secondary Outcomes
- 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))
- Grip force assessed by means of dynamometer(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))
Investigators
Aline de Souza Pagnussat
PhD
Federal University of Health Science of Porto Alegre
Study Sites (1)
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