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

Seoul National University logo

Seoul National University

Status

Completed

Conditions

Stroke

Treatments

Device: Robotic-assisted gait training
Device: tDCS

Study type

Interventional

Funder types

Other

Identifiers

NCT01945515
Robot-tDCS-2013

Details and patient eligibility

About

  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 chronic stroke patients

  2. Subjects chronic stroke patients with gait impairment

  3. Methods

    • Group 1: Robotic-assisted gait training with anodal tDCS (45 min)
    • Group 2: Robotic-assisted gait training with sham tDCS (45 min)
    • Duration of treatment: 2 weeks, 5 times a week
    • Evaluation: Baseline, 1 day after the treatment, 4 weeks after the treatment

Enrollment

21 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Stroke patients who diagnosed by computed tomography or magnetic resonance imaging
  • Hemiplegic patients due to unilateral lesion
  • Patients in chronic stage after 6 months from stroke onset
  • Patients with gait impairment (FAC <= 4)
  • Adult (Age >= 18)

Exclusion criteria

  • Unstable vital sign
  • History of seizure or cranial operation
  • unable to walk before stroke
  • bilateral hemispheric lesions
  • metalic implant (cardiac pacemaker, artificial cochlear, etc.)
  • severe cognitive deficit, MMSE < 10
  • severe aphasic patient who cannot communicate at all

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

21 participants in 2 patient groups

Robot + anodal tDCS
Experimental group
Description:
Robotic-assisted gait training for 45 min after anodal tDCS on impaired motor cortex for 20 min
Treatment:
Device: tDCS
Device: Robotic-assisted gait training
Robot + sham tDCS
Sham Comparator group
Description:
Robotic-assisted gait training for 45 min after sham tDCS on impaired motor cortex for 20 min
Treatment:
Device: tDCS
Device: Robotic-assisted gait training

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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