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Completed

NCT Number: NCT02818608

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

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Federal University of Health Sciences of Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Functional Electrical Stimulation (FES)

Device

Functional Electrical Stimulation (FES) + Sham Transcranial direct brain stimulation (tDCS)

Combination of Transcranial direct brain stimulation (tDCS) and FES

Device

Real Functional Electrical Stimulation (FES) + Real Transcranial direct brain stimulation (tDCS)

Primary outcomes

  1. 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

  1. Grip force assessed by means of dynamometer

    Time frame: Change from Pre to Post 1 (after the 10th session) and Post 3 (3 months follow-up)

    Evaluated by means of dynamometer (Jamar)

  2. Manual dexterity assessed by means of the block and box test

    Time frame: Change from Pre to Post 1 (after the 10th session) and Post 3 (3 months follow-up)

    Block and box test

  3. Quality of life assessed by means of the Stroke-Specific Quality of Life (SSQOL)

    Time frame: Change from Pre to Post 1 (after the 10th session) and Post 3 (3 months follow-up)

    Questionnaire

  4. Muscular tone assessed by the Modified Ashworth Scale

    Time frame: Change from Pre to Post 1 (after the 10th session) and Post 3 (3 months follow-up)

    Modified Ashworth Scale

  5. Assessment of Sensorimotor Recovery After Stroke by the Fugl-Meyer scale

    Time frame: Change from Pre to Post 1 (after the 10th session) and Post 3 (3 months follow-up)

    Fugl-Meyer scale

Sponsors and collaborators

Lead sponsor

Federal University of Health Science of Porto Alegre

Other

Registry information

Official study title

Association Between the Transcranial Direct Current Stimulation (tDCS) and Functional Electrical Stimulation (FES) for Upper-limb Rehabilitation After Stroke - A Randomized Clinical Trial

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Jun 30, 2016
Registry last updated
Jun 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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