Clinical trial NCT01945515: Robotic-assisted Gait Training Combined With Transcranial Direct Current Stimulation to Maximize Gait Recovery After Stroke
Official title: Robotic-assisted Gait Training Combined With Transcranial Direct Current Stimulation to Maximize Gait Recovery After Stroke: A Double-blind, Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke
transcranial direct current stimulation
robotic rehabilitation
gait
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2013-09-18
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Functional Ambulatory Category (FAC)
timeFrame: Baseline
measure: Functional Ambulatory Category (FAC)
timeFrame: 1 day after treatment
measure: Functional Ambulatory Category (FAC)
timeFrame: 4 weeks after treatment
Secondary outcomes:
measure: 10-meter walk test
timeFrame: Baseline
measure: 10-meter walk test
timeFrame: 1 day after treatment
measure: 10-meter walk test
timeFrame: 4 weeks after treatment
measure: 6-min walk test
timeFrame: Baseline
measure: 6-min walk test
timeFrame: 1 day after treatment
measure: 6-min walk test
timeFrame: 4 weeks after treatment
measure: Modified Rankin's Scale
timeFrame: Baseline
measure: Modified Rankin's Scale
timeFrame: 1 day after treatment
measure: Modified Rankin's Scale
timeFrame: 4 weeks after treatment
measure: Fugl-Meyer assessment scale for lower extremity
timeFrame: Baseline
measure: Fugl-Meyer assessment scale for lower extremity
timeFrame: 1 day after treatment
measure: Fugl-Meyer assessment scale for lower extremity
timeFrame: 4 weeks after treatment
measure: Motor evoked potential
timeFrame: Baseline
measure: Motor evoked potential
timeFrame: 1 day after treatment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Byung-Mo Oh, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: