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
|Condition or disease||Intervention/treatment||Phase|
|Gait, Unsteady Healthy||Device: Samsung Hip Assist v1||Not Applicable|
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|
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.
- 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."
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03325998
|Korea, Republic of|
|Samsung Medical Center|
|Seoul, Korea, Republic of|
|Principal Investigator:||Yun-Hee Kim, MD, PhD||Samsung Medical Center|