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

Stroke Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02818608
• Other study ID #: APAPS2018
• Status: Completed
• Phase: N/A
• Start date: August 14, 2017
• Est. completion date: January 15, 2019

Study information

• Verified date: June 2019
• Source: Federal University of Health Science of Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: January 15, 2019
• Est. primary completion date: August 13, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Functional Electrical Stimulation (FES)
Functional Electrical Stimulation (FES) + Sham Transcranial direct brain stimulation (tDCS)
• Combination of Transcranial direct brain stimulation (tDCS) and FES
Real Functional Electrical Stimulation (FES) + Real Transcranial direct brain stimulation (tDCS)

Locations

Country	Name	City	State
Brazil	Federal University of Health Sciences of Porto Alegre	Porto Alegre	Rio Grande Do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Health Science of Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Grip force assessed by means of dynamometer	Evaluated by means of dynamometer (Jamar)	Change from Pre to Post 1 (after the 10th session) and Post 3 (3 months follow-up)
Secondary	Manual dexterity assessed by means of the block and box test	Block and box test	Change from Pre to Post 1 (after the 10th session) and Post 3 (3 months follow-up)
Secondary	Quality of life assessed by means of the Stroke-Specific Quality of Life (SSQOL)	Questionnaire	Change from Pre to Post 1 (after the 10th session) and Post 3 (3 months follow-up)
Secondary	Muscular tone assessed by the Modified Ashworth Scale	Modified Ashworth Scale	Change from Pre to Post 1 (after the 10th session) and Post 3 (3 months follow-up)
Secondary	Assessment of Sensorimotor Recovery After Stroke by the Fugl-Meyer scale	Fugl-Meyer scale	Change from Pre to Post 1 (after the 10th session) and Post 3 (3 months follow-up)