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

NCT03326011 | Completed

• 1 other identifier: 2017-06-012
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gait Disorders, Neurologic; Stroke

Keywords

Exoskeleton Device; Gait rehabilitation; Chronic storke

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

Gait training group

EXPERIMENTAL

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

Interventions

Samsung Hip Assist v1 DEVICE

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.

Gait training group

Eligibility Criteria

• Age: 20 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Gait Disorders, Neurologic; Stroke

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Yun-Hee Kim, MD, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2017
• First Posted: October 30, 2017
• Study Start: November 1, 2017
• Primary Completion: February 28, 2018
• Study Completion: February 28, 2018
• Last Updated: April 18, 2018

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)