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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03326011
• Other study ID #: 2017-06-012
• Status: Completed
• Phase: N/A
• First received: October 26, 2017
• Last updated: April 16, 2018
• Start date: November 1, 2017
• Est. completion date: February 28, 2018

Study information

• Verified date: October 2017
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: February 28, 2018
• Est. primary completion date: February 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 84 Years

Eligibility

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

Related Conditions & MeSH terms

• Gait Disorders, Neurologic
• Nervous System Diseases
• Stroke

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)