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

Recruiting

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • Functional electrical stimulation (FES) Device
    Intervention Desc: Functional Electrical Stimulation (FES) + Sham Transcranial direct brain stimulation (tDCS)
    ARM 1: Kind: Experimental
    Label: Functional electrical stimulation (FES)
    Description: Chronic stroke patients submitted to functional electrical stimulation (FES).
  • Transcranial direct brain stimulation (tDCS) Device
    Intervention Desc: Transcranial direct brain stimulation (tDCS) + Sham Functional Electrical Stimulation (FES)
    ARM 1: Kind: Experimental
    Label: Transcranial direct current stimulation (tDCS)
    Description: Chronic stroke patients submitted to transcranial direct current stimulation (tDCS).
  • Combination of tDCS and FES Device
    Intervention Desc: Real Functional Electrical Stimulation (FES) + Real Transcranial direct brain stimulation (tDCS)
    ARM 1: Kind: Experimental
    Label: Combination of tDCS and FES
    Description: Chronic stroke patients submitted to transcranial direct current stimulation (tDCS) and functional and to functional electrical stimulation (FES).
  • Combination of Transcranial direct brain stimulation (tDCS) and FES Device
    Intervention Desc: Real Functional Electrical Stimulation (FES) + Real Transcranial direct brain stimulation (tDCS)
    ARM 1: Kind: Experimental
    Label: Combination of transcranial direct current stimulation and FES
    Description: Chronic stroke patients submitted to transcranial direct current stimulation (tDCS) and functional and to functional electrical stimulation (FES).

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary 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 5th session), Post 2 (after the 10th session) and Post 3 (3 months follow-up) No
Primary Gait analysis evaluated by means of the 3-D motion analysis system (BTS SMART DX 400) Change from Pre to Post 1 (after the 5th session), Post 2 (after the 10th session) and Post 3 (3 months follow-up) No
Primary Postural Control evaluated by means of force platform (BTS P-6000) Change from Pre to Post 1 (after the 5th session), Post 2 (after the 10th session) and Post 3 (3 months follow-up) No
Secondary Grip force assessed by means of dynamometer Change from Pre to Post 1 (after the 5th session), Post 2 (after the 10th session) and Post 3 (3 months follow-up) No
Secondary Strength of wrist flexors and extensors evaluated by means of cell load Change from Pre to Post 1 (after the 5th session), Post 2 (after the 10th session) and Post 3 (3 months follow-up) No
Secondary Muscular activity of wrist flexors and extensors, evaluated by means of Electromyography Change from Pre to Post 1 (after the 5th session), Post 2 (after the 10th session) and Post 3 (3 months follow-up) No
Secondary Uni-manual hand functions required for activities of daily living via Jebsen Hand Function Test Change from Pre to Post 1 (after the 5th session), Post 2 (after the 10th session) and Post 3 (3 months follow-up) No
Secondary Manual dexterity assessed by means of the block and box test Change from Pre to Post 1 (after the 5th session), Post 2 (after the 10th session) and Post 3 (3 months follow-up) No
Secondary Hand sensibility assessed by means of esthesiometer Change from Pre to Post 1 (after the 5th session), Post 2 (after the 10th session) and Post 3 (3 months follow-up) No
Secondary Quality of life assessed by means of the Stroke-Specific Quality of Life (SSQOL) Change from Pre to Post 1 (after the 5th session), Post 2 (after the 10th session) and Post 3 (3 months follow-up) Yes
Secondary Serum levels of Cortisol, BDNF, IGF-1 and IGFBP-3 Change from Pre to Post 1 (after the 5th session), Post 2 (after the 10th session) and Post 3 (3 months follow-up) No
Secondary Muscular tone assessed by the Modified Ashworth Scale Change from Pre to Post 1 (after the 5th session), Post 2 (after the 10th session) and Post 3 (3 months follow-up) No
Secondary Assessment of Sensorimotor Recovery After Stroke by the Fugl-Meyer scale Change from Pre to Post 1 (after the 5th session), Post 2 (after the 10th session) and Post 3 (3 months follow-up) No

Sponsors