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

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
tDCS
Robotic-assisted gait training
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, transcranial direct current stimulation, robotic rehabilitation, gait

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Robot + anodal tDCS

Robot + sham tDCS

Arm Description

Robotic-assisted gait training for 45 min after anodal tDCS on impaired motor cortex for 20 min

Robotic-assisted gait training for 45 min after sham tDCS on impaired motor cortex for 20 min

Outcomes

Primary Outcome Measures

Functional Ambulatory Category (FAC)
Assesses functional ambulation in patients undergoing physical therapy
Functional Ambulatory Category (FAC)
Assesses functional ambulation in patients undergoing physical therapy
Functional Ambulatory Category (FAC)
Assesses functional ambulation in patients undergoing physical therapy

Secondary Outcome Measures

10-meter walk test
Time for walking 10 meters
10-meter walk test
Time for walking 10 meters
10-meter walk test
Time for walking 10 meters
6-min walk test
Walking distance for 6 min
6-min walk test
Walking distance for 6 min
6-min walk test
Walking distance for 6 min
Modified Rankin's Scale
Modified Rankin's Scale
Modified Rankin's Scale
Fugl-Meyer assessment scale for lower extremity
Assess the function of lower extremity in stroke patients
Fugl-Meyer assessment scale for lower extremity
Assess the function of lower extremity in stroke patients
Fugl-Meyer assessment scale for lower extremity
Assess the function of lower extremity in stroke patients
Motor evoked potential
Assess motor pathway from brain cortex to the muscle by transcranial magnetic stimulation
Motor evoked potential
Assess motor pathway from brain cortex to the muscle by transcranial magnetic stimulation

Full Information

First Posted
September 15, 2013
Last Updated
December 18, 2016
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01945515
Brief Title
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

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

5. Study Description

Brief Summary
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 Subjects chronic stroke patients with gait impairment 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, transcranial direct current stimulation, robotic rehabilitation, gait

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Robot + anodal tDCS
Arm Type
Experimental
Arm Description
Robotic-assisted gait training for 45 min after anodal tDCS on impaired motor cortex for 20 min
Arm Title
Robot + sham tDCS
Arm Type
Sham Comparator
Arm Description
Robotic-assisted gait training for 45 min after sham tDCS on impaired motor cortex for 20 min
Intervention Type
Device
Intervention Name(s)
tDCS
Other Intervention Name(s)
DC-Stimulator Plus (NeuroConn GmbH, Ilmenaus, Germany)
Intervention Description
tDCS will be applied on the primary motor cortex of the lower limb in the impared hemisphere before 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.
Intervention Type
Device
Intervention Name(s)
Robotic-assisted gait training
Other Intervention Name(s)
Walkbot_S (P&S Mechanics Co. Ltd., Seoul, Korea)
Intervention Description
Robotic-assisted gait training with an exoskeletal type robot which simulates normal walking on a treadmill for patients with gait impairments
Primary Outcome Measure Information:
Title
Functional Ambulatory Category (FAC)
Description
Assesses functional ambulation in patients undergoing physical therapy
Time Frame
Baseline
Title
Functional Ambulatory Category (FAC)
Description
Assesses functional ambulation in patients undergoing physical therapy
Time Frame
1 day after treatment
Title
Functional Ambulatory Category (FAC)
Description
Assesses functional ambulation in patients undergoing physical therapy
Time Frame
4 weeks after treatment
Secondary Outcome Measure Information:
Title
10-meter walk test
Description
Time for walking 10 meters
Time Frame
Baseline
Title
10-meter walk test
Description
Time for walking 10 meters
Time Frame
1 day after treatment
Title
10-meter walk test
Description
Time for walking 10 meters
Time Frame
4 weeks after treatment
Title
6-min walk test
Description
Walking distance for 6 min
Time Frame
Baseline
Title
6-min walk test
Description
Walking distance for 6 min
Time Frame
1 day after treatment
Title
6-min walk test
Description
Walking distance for 6 min
Time Frame
4 weeks after treatment
Title
Modified Rankin's Scale
Time Frame
Baseline
Title
Modified Rankin's Scale
Time Frame
1 day after treatment
Title
Modified Rankin's Scale
Time Frame
4 weeks after treatment
Title
Fugl-Meyer assessment scale for lower extremity
Description
Assess the function of lower extremity in stroke patients
Time Frame
Baseline
Title
Fugl-Meyer assessment scale for lower extremity
Description
Assess the function of lower extremity in stroke patients
Time Frame
1 day after treatment
Title
Fugl-Meyer assessment scale for lower extremity
Description
Assess the function of lower extremity in stroke patients
Time Frame
4 weeks after treatment
Title
Motor evoked potential
Description
Assess motor pathway from brain cortex to the muscle by transcranial magnetic stimulation
Time Frame
Baseline
Title
Motor evoked potential
Description
Assess motor pathway from brain cortex to the muscle by transcranial magnetic stimulation
Time Frame
1 day after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Byung-Mo Oh, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

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

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