Clinical Trials Directory

Trials / Completed

CompletedNCT03325998

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
8 (actual)
Sponsor
Samsung Medical Center · Academic / Other
Sex
All
Age
65 Years – 84 Years
Healthy volunteers
Not accepted

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).

Conditions

Interventions

TypeNameDescription
DEVICESamsung Hip Assist v1All 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.

Timeline

Start date
2017-11-01
Primary completion
2018-02-28
Completion
2018-02-28
First posted
2017-10-30
Last updated
2018-04-18

Locations

1 site across 1 country: South Korea

Source: ClinicalTrials.gov record NCT03325998. Inclusion in this directory is not an endorsement.