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Effect of Gait Training With a Walking Assist Robot on Gait Function and Balance in Elderly Adults

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ClinicalTrials.gov Identifier: NCT03325998
Recruitment Status : Completed
First Posted : October 30, 2017
Last Update Posted : April 18, 2018
Sponsor:
Information provided by (Responsible Party):
Samsung Medical Center

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 elderly adults.

Condition or disease Intervention/treatment Phase
Gait, Unsteady Healthy Device: Samsung Hip Assist v1 Not Applicable

Detailed Description:

Eight elderly adults 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 Short Physical Performance Battery Protocol and Score Sheet (SPPB), 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  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Effect of Gait Training With a Walking Assist Robot on Gait Function and Balance in Elderly Adults
Actual Study Start Date : November 1, 2017
Actual Primary Completion Date : February 28, 2018
Actual Study Completion Date : February 28, 2018

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.




Primary Outcome Measures :
  1. Change in 10 meter walk test from baseline in gait speed [ Time Frame: session 0 (initial visit); session 24 (at approximately 8 weeks); at 3 months (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."



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Ages Eligible for Study:   65 Years to 84 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age: between 65 and 84 years elderly adults who had no neurological or musculoskeletal abnormalities affecting gait
  2. Ability to walk at least 10m regardless of assist devices
  3. High levels of physical performance (SPPB > 7)
  4. Subject is willing to be randomized to the control group or the treatment group

Exclusion Criteria:

  1. History of any diseases (eg. lower extremity orthopedic diseases, neurologic disorders, cardiovascular disease, heart failure, uncontrolled hypertension that affect walking capacity, efficiency, and endurance)
  2. Severe visual impairment or dizziness that increases the risk of falls

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03325998


Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Yun-Hee Kim, MD, PhD Samsung Medical Center

Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT03325998     History of Changes
Other Study ID Numbers: 2017-04-061
First Posted: October 30, 2017    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Samsung Medical Center:
Exoskeleton Device
Elderly
Gait rehabilitation

Additional relevant MeSH terms:
Gait Disorders, Neurologic
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms