Study to Enhance Motor Acute Recovery With Intensive Training After Stroke "SMARTS2"

Recruiting

Phase N/A Results N/A

Trial Description

Stroke often results in limitation of arm movements, from which many people do not fully recover. We believe that early and intensive therapy is important to enhance recovery of arm movements after stroke. We are doing this research study to see how much arm movements improve with intensive therapy in patients have had a stroke in the past 6 weeks.

Conditions

Interventions

  • TDCS Device
    ARM 1: Kind: Experimental
    Label: Device-assisted arm therapy with tDCS
    Description: 30 hours of therapy with the ArmeoPower device, a commercially available device for arm rehabilitation, with tDCS
  • Device-assisted therapy Behavioral
    ARM 1: Kind: Experimental
    Label: Device-assisted arm therapy with tDCS
    Description: 30 hours of therapy with the ArmeoPower device, a commercially available device for arm rehabilitation, with tDCS
    ARM 2: Kind: Experimental
    Label: Device-assisted therapy with sham tDCS
    Description: 30 hours of therapy with the ArmeoPower device, a commercially available device for arm rehabilitation, with sham tDCS
    ARM 3: Kind: Experimental
    Label: Device-assisted therapy
    Description: 30 hours of therapy with the ArmeoPower device, a commercially available device for arm rehabilitation
  • Therapy-based occupational therapy Behavioral
    ARM 1: Kind: Experimental
    Label: Therapy-based occupational therapy
    Description: 30 hours of conventional occupational therapy that emphasizes task-oriented training.

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Fugl-Meyer Upper Extremity (FM-UE) from baseline to day 3 post-training No

Sponsors