Effect of Gait Training With a Walking Assist Robot on Gait Function and Balance in Patients With Chronic Stroke

The purpose of this study was to investigate the effects of gait training with the new wearable hip assist robot developed by Samsung Advance Institute of Technology (Samsung Electronics Co, Ltd, Korea) in patients with chronic stroke.

Study Overview

• Status: Completed
• Conditions: Stroke; Gait Disorders, Neurologic
• Intervention / Treatment: Device: Samsung Hip Assist v1

Detailed Description

Seven chronic stroke patients will participate in this study. All subjects will receive training 3 times per week for 8 weeks for 24 training sessions. Each session is directed by a licensed physical therapist and lasted 60 min (including rest period of 10 min). Brain activity and gait assessment will be performed at visits 0 (baseline), 24 (post-test), and at 3 months (follow-up) after training.

Primary objective is to demonstrate the effects of hip assist robot on spatio-temporal parameters measured by motion capture system (Motion Analysis Corporation, Santa Rosa, CA, USA), muscle activation patterns measured by surface electromyography (sEMG) (Noraxon Inc., Scottsdale, AZ, USA), metabolic energy cost parameters measured by portable cardiopulmonary metabolic system (Cosmed K4B2, Rome, Italy) and cortical activation measured by functional Near-Infrared-Spectroscopy (fNIRS) (NIRScout, NIRx, Germany).

Secondary objective is to demonstrate the effects of hip assist robot on motor function improvement evaluated by Berg Balance Scale (BBS), Dynamic Gait Index (DGI), Timed Up and Go (TUG) test, Push and Release (P&R) test, Functional Reach Test (FRT), Korean version Fall Efficacy Scale (K-FES), Manual Muscle Test (MMT) and Range of Motion (ROM).

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 84 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age: between 20 and 84 years
2. ≥ 3 months post stroke
3. Ability to walk at least 10m regardless of assist devices
4. Adequate gait function (FAC > 3)
5. Physician approval for patient participation

Exclusion Criteria:

1. 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)
2. Advanced liver, kidney, cardiac, or pulmonary disease
3. History of concussion in last 6 months
4. History of unexplained, recurring headaches, epilepsy/seizures/skull fractures or skull deficits
5. Preexisting neurological disorders such as Parkinson's disease, Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), dementia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DEVICE_FEASIBILITY
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Gait training group; Gait training with Samsung Hip Assist v1 All subjects receive gait training 3 times per week for 8 weeks for 24 training sessions.	Device: Samsung Hip Assist v1; All subjects receive gait training 3 times per week for 8 weeks for 24 training sessions. Each session is directed by a licensed physical therapist and lasted 60 min including rest period of 10 min. Brain activity and gait assessment is performed at visits 0 (baseline), 24 (post-test), and at 3 months (follow-up) after training.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in 10 meter walk test from baseline in gait speed	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."	session 0 (initial visit); session 24 (at approximately 8 weeks); at 3 months (follow-up)

Collaborators and Investigators

• Sponsor: Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2017
• Primary Completion (ACTUAL): February 28, 2018
• Study Completion (ACTUAL): February 28, 2018

Study Registration Dates

• First Submitted: October 26, 2017
• First Submitted That Met QC Criteria: October 26, 2017
• First Posted (ACTUAL): October 30, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 18, 2018
• Last Update Submitted That Met QC Criteria: April 16, 2018
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Exoskeleton Device; Gait rehabilitation; Chronic storke
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Neurologic Manifestations; Stroke; Nervous System Diseases; Gait Disorders, Neurologic
• Other Study ID Numbers: 2017-06-012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No