Effect of Gait Training With a Walking Assist Robot on Gait Function and Balance in Elderly Adults
Primary Purpose
Gait, Unsteady, Healthy
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Samsung Hip Assist v1
Sponsored by
About this trial
This is an interventional device feasibility trial for Gait, Unsteady focused on measuring Exoskeleton Device, Elderly, Gait rehabilitation
Eligibility Criteria
Inclusion Criteria:
- Age: between 65 and 84 years elderly adults who had no neurological or musculoskeletal abnormalities affecting gait
- Ability to walk at least 10m regardless of assist devices
- High levels of physical performance (SPPB > 7)
- Subject is willing to be randomized to the control group or the treatment group
Exclusion Criteria:
- History of any diseases (eg. lower extremity orthopedic diseases, neurologic disorders, cardiovascular disease, heart failure, uncontrolled hypertension that affect walking capacity, efficiency, and endurance)
- Severe visual impairment or dizziness that increases the risk of falls
Sites / Locations
- Samsung Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Gait training group
Arm Description
Gait training with Samsung Hip Assist v1 All subjects receive gait training 3 times per week for 8 weeks for 24 training sessions.
Outcomes
Primary Outcome Measures
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."
Secondary Outcome Measures
Full Information
NCT ID
NCT03325998
First Posted
October 26, 2017
Last Updated
April 16, 2018
Sponsor
Samsung Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03325998
Brief Title
Effect of Gait Training With a Walking Assist Robot on Gait Function and Balance in Elderly Adults
Official Title
Effect of Gait Training With a Walking Assist Robot on Gait Function and Balance in Elderly Adults
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
February 28, 2018 (Actual)
Study Completion Date
February 28, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samsung Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gait, Unsteady, Healthy
Keywords
Exoskeleton Device, Elderly, Gait rehabilitation
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gait training group
Arm Type
Experimental
Arm Description
Gait training with Samsung Hip Assist v1
All subjects receive gait training 3 times per week for 8 weeks for 24 training sessions.
Intervention Type
Device
Intervention Name(s)
Samsung Hip Assist v1
Intervention Description
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 Measure Information:
Title
Change in 10 meter walk test from baseline in gait speed
Description
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."
Time Frame
session 0 (initial visit); session 24 (at approximately 8 weeks); at 3 months (follow-up)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
84 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age: between 65 and 84 years elderly adults who had no neurological or musculoskeletal abnormalities affecting gait
Ability to walk at least 10m regardless of assist devices
High levels of physical performance (SPPB > 7)
Subject is willing to be randomized to the control group or the treatment group
Exclusion Criteria:
History of any diseases (eg. lower extremity orthopedic diseases, neurologic disorders, cardiovascular disease, heart failure, uncontrolled hypertension that affect walking capacity, efficiency, and endurance)
Severe visual impairment or dizziness that increases the risk of falls
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yun-Hee Kim, MD, PhD
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
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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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