Robotic-assisted Gait Training Combined With Transcranial Direct Current Stimulation to Maximize Gait Recovery After Stroke

Recruiting

Phase N/A Results N/A

Trial Description

1. Study objective To evaluate the effect of robotic-assisted gait training combined with transcranial direct current stimulation (tDCS) as compared to that of robotic-assisted gait training on gait function of subacute stroke patients
2. Subjects subacute stroke patients who cannot walk independently
3. Methods
- Group 1: Robotic-assisted gait training with anodal tDCS (30 min) + conventional gait training on ground (30 min)
- Group 2: Robotic-assisted gait training with sham tDCS (30 min) + conventional gait training on ground (30 min)
- Duration of treatment: 2 weeks, 5 times a week
- Evaluation: Baseline, 1 day after the treatment, 12 weeks after the treatment

Conditions

Interventions

  • TDCS Device
    Intervention Desc: tDCS will be applied on the primary motor cortex of the lower limb in the impared hemisphere during robotic-assisted gait training. Anodal tDCS will be applied with an intensity of 2mA for 20 min. Sham tDCS will be applied with an intensity of 2mA just for 1 min, after which the current will be slowly tapered down to 0 over a several seconds.
    ARM 1: Kind: Experimental
    Label: Robot + anodal tDCS
    Description: Robotic-assisted gait training with anodal tDCS on impaired motor cortex for 30 min a day and conventional gait training with a physical therapist for 30 min a day
    ARM 2: Kind: Experimental
    Label: Robot + sham tDCS
    Description: Robotic-assisted gait training with sham tDCS on impaired motor cortex for 30 min a day and conventional gait training with a physical therapist for 30 min a day
  • Robotic-assisted gait training Other
    Intervention Desc: Robotic-assisted gait training with an exoskeletal type robot which simulates normal walking on a treadmill for patients with gait impairments
    ARM 1: Kind: Experimental
    Label: Robot + anodal tDCS
    Description: Robotic-assisted gait training with anodal tDCS on impaired motor cortex for 30 min a day and conventional gait training with a physical therapist for 30 min a day
    ARM 2: Kind: Experimental
    Label: Robot + sham tDCS
    Description: Robotic-assisted gait training with sham tDCS on impaired motor cortex for 30 min a day and conventional gait training with a physical therapist for 30 min a day

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary Functional Ambulatory Category (FAC) Baseline No
Secondary 10-meter walk test Baseline No
Secondary 6-min walk test Baseline No
Secondary Modified Rankin's Scale Baseline No
Secondary Fugl-Meyer assessment scale for lower extremity Baseline No
Secondary Motor evoked potential Baseline No

Sponsors