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Clinical Trials/NCT01945515
NCT01945515
Completed
Not Applicable

Robotic-assisted Gait Training Combined With Transcranial Direct Current Stimulation to Maximize Gait Recovery After Stroke: A Double-blind, Randomized, Controlled Trial

Seoul National University Hospital1 site in 1 country21 target enrollmentSeptember 2013
ConditionsStroke

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Seoul National University Hospital
Enrollment
21
Locations
1
Primary Endpoint
Functional Ambulatory Category (FAC)
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

  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
Registry
clinicaltrials.gov
Start Date
September 2013
End Date
December 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Byung-Mo Oh

Clinical Professor

Seoul National University Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Functional Ambulatory Category (FAC)

Time Frame: 4 weeks after treatment

Assesses functional ambulation in patients undergoing physical therapy

Secondary Outcomes

  • 6-min walk test(4 weeks after treatment)
  • Fugl-Meyer assessment scale for lower extremity(4 weeks after treatment)
  • Motor evoked potential(1 day after treatment)
  • 10-meter walk test(4 weeks after treatment)
  • Modified Rankin's Scale(4 weeks after treatment)

Study Sites (1)

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