Effect of Robot Gait Training With Brain Stimulation on Gait Function in Stroke Patients

• Sponsor: Samsung Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT03708016
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Actual Duration (Months): 17
• Patients Per Site Per Month: 1.8

Study Details

Study Description

Brief Summary

The purpose of this study was to investigate the effects of robot gait training with the noninvasive brain stimulation in stroke patients.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Device: Robot gait training; Device: Brain stimulation	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effect of Robot Gait Training With Brain Stimulation on Gait Function in Stroke Patients
• Actual Study Start Date: Oct 18, 2018
• Actual Primary Completion Date: Mar 17, 2020
• Actual Study Completion Date: Mar 17, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Robot gait training with brain stimulation Lokomat robot training and anodal transcranial direct current stimulation (tDCS) on the leg motor areas	Device: Robot gait training; Lokomat robot training was applied to stroke patients.; Device: Brain stimulation; tDCS brain stimulation on leg motor areas was applied to stroke patients.
Active Comparator: Robot gait training without brain stimulation Lokomat robot training and sham tDCS on the leg motor areas	Device: Robot gait training; Lokomat robot training was applied to stroke patients.

Outcome Measures

Primary Outcome Measures

1. Change in 10 meter walk test from baseline in gait speed [session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up)]

   Measure of self selected speeds by measuring the time it takes an individual to walk 10 meters. To perform the test, patient walks 10 meters (33 ft) and the time is measured when the leading foot crosses the start line and the finish line. The instructions are: "Please walk this distance at your normal pace when I say go."

Secondary Outcome Measures

1. Change in Berg Balance Scale from baseline in balance [session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up)]

   Meserue of blance function

2. Change in Functional ambulatory category from baseline in gait function [session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up)]

   Measure of functional ambulatory category

3. Change in Timed Up and Go test from baseline in balance [session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up)]

   Measure of Timued Up and Go test in balance

4. Change on gait function (kinematic) [session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up)]

   All participants perform overground walking to assess the change of kinematic using a motion analysis.

5. Change on gait function (kinetic) [session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up)]

   All participants perform overground walking to assess the change of kinetic using a force plate

6. Change on gait function (muslce activation) [session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up)]

   All participants perform overground walking to assess the change of muscle activation using a surface EMG.

7. Changes in motor evoked potentia [session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up)]

   measure the motor threshold and amplitude of motor evoked potential in first dorsal interosseous muscle and TA muscle.

8. Changes in Brain activation of resting-state functional MRI [session 0 (initial visit); session 10 (at approximately 3 weeks); after 1 months from intervention termination (follow-up)]

   Neuroplasticity measure

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age: more than 18 years

• More than 6 months post stroke

• Functional ambulation classification (FAC) (1~4)

Exclusion Criteria:

• Serious cardiac conditions (hospitalization for myocardial infarction or heart surgery within 3 months, history of congestive heart failure, documented serious and unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living)

• Difficult to understand experimental tasks because of extremely severe cognitive impairment

• History of disorders involving central nervous system

• History of psychiatric disease

• implanted objects that would contraindicate tDCS

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Samsung Medical Center	Seoul	Gangnam-gu	Korea, Republic of	06351

Sponsors and Collaborators

• Samsung Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Samsung Medical Center
• ClinicalTrials.gov Identifier: NCT03708016
• Other Study ID Numbers: 2018-05-015
• First Posted: Oct 16, 2018
• Last Update Posted: May 27, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Stroke

Study Results

No Results Posted as of May 27, 2020