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

Not Applicable

Completed

• Conditions: Stroke

• Registration Number: NCT02818608
• Lead Sponsor: Federal University of Health Science of Porto Alegre

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-11-02
• Study First Submitted QC: 2016-06-27
• Study First Posted: 2016-06-30
• Study Start: 2017-08-14
• Primary Completion: 2018-08-13
• Study Completion: 2019-01-15
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-12
• Last Update Posted: 2019-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Upper-limb reaching analysis evaluated by means of the 3-D motion analysis system (BTS SMART DX 400)	Change from Pre to Post 1 (after the 10th session) and Post 3 (3 months follow-up)	3-D motion analysis system

Secondary Outcome Measures

Name	Time	Method
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)	Block and box test
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)	Questionnaire
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)	Modified Ashworth Scale
Grip force assessed by means of dynamometer	Change from Pre to Post 1 (after the 10th session) and Post 3 (3 months follow-up)	Evaluated by means of dynamometer (Jamar)
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)	Fugl-Meyer scale

Trial Locations

Locations (1)

Federal University of Health Sciences of Porto Alegre; 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil