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

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

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

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Device: tDCS; Device: Robotic-assisted gait training

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-744
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Robot + anodal tDCS; Robotic-assisted gait training for 45 min after anodal tDCS on impaired motor cortex for 20 min	Device: tDCS; 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.; Other Names: DC-Stimulator Plus (NeuroConn GmbH, Ilmenaus, Germany); Device: Robotic-assisted gait training; Robotic-assisted gait training with an exoskeletal type robot which simulates normal walking on a treadmill for patients with gait impairments; Other Names: Walkbot_S (P&S Mechanics Co. Ltd., Seoul, Korea)
Sham Comparator: Robot + sham tDCS; Robotic-assisted gait training for 45 min after sham tDCS on impaired motor cortex for 20 min	Device: tDCS; 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.; Other Names: DC-Stimulator Plus (NeuroConn GmbH, Ilmenaus, Germany); Device: Robotic-assisted gait training; Robotic-assisted gait training with an exoskeletal type robot which simulates normal walking on a treadmill for patients with gait impairments; Other Names: Walkbot_S (P&S Mechanics Co. Ltd., Seoul, Korea)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Ambulatory Category (FAC)	Assesses functional ambulation in patients undergoing physical therapy	Baseline
Functional Ambulatory Category (FAC)	Assesses functional ambulation in patients undergoing physical therapy	1 day after treatment
Functional Ambulatory Category (FAC)	Assesses functional ambulation in patients undergoing physical therapy	4 weeks after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
10-meter walk test	Time for walking 10 meters	Baseline
10-meter walk test	Time for walking 10 meters	1 day after treatment
10-meter walk test	Time for walking 10 meters	4 weeks after treatment
6-min walk test	Walking distance for 6 min	Baseline
6-min walk test	Walking distance for 6 min	1 day after treatment
6-min walk test	Walking distance for 6 min	4 weeks after treatment
Modified Rankin's Scale		Baseline
Modified Rankin's Scale		1 day after treatment
Modified Rankin's Scale		4 weeks after treatment
Fugl-Meyer assessment scale for lower extremity	Assess the function of lower extremity in stroke patients	Baseline
Fugl-Meyer assessment scale for lower extremity	Assess the function of lower extremity in stroke patients	1 day after treatment
Fugl-Meyer assessment scale for lower extremity	Assess the function of lower extremity in stroke patients	4 weeks after treatment
Motor evoked potential	Assess motor pathway from brain cortex to the muscle by transcranial magnetic stimulation	Baseline
Motor evoked potential	Assess motor pathway from brain cortex to the muscle by transcranial magnetic stimulation	1 day after treatment

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Byung-Mo Oh, MD, PhD, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: September 15, 2013
• First Submitted That Met QC Criteria: September 17, 2013
• First Posted (Estimate): September 18, 2013

Study Record Updates

• Last Update Posted (Estimate): December 20, 2016
• Last Update Submitted That Met QC Criteria: December 18, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: transcranial direct current stimulation; Stroke; gait; robotic rehabilitation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: Robot-tDCS-2013