The purpose of this study is to investigate the effect of training with the Gait
Enhancing and Motivating System-Hip (GEMS-H) vs. training without the GEMS-H on locomotor
function in adults. The investigator hypothesizes that long-term GEMS-H use would improve
locomotor function. Specifically, individuals in the GEMS-H group will show faster gait
speed compared to those in the control group.

Effect of GEMS-H on Locomotor Function in Adults

Adults

Middle Age

Aged

Aged, 80 and Over

The GEMS-H is a hip-type assist device developed by Samsung Electronics. The GEMS-H is
worn around the waist and fastened at the waist and thighs by a set of belts with velcro
to assist motion at the hip joints. The device weighs 2.1kg, and has 2 brushless direct
current motors running on a rechargeable lithium ion battery. The normal operation time
for the device is 2 hours. It is controlled through a custom built application on a hand
held tablet.

The purpose of this study is to investigate the effect of training with the Gait
Enhancing and Motivating System-Hip (GEMS-H) vs. training without the GEMS-H on locomotor
function in adults. The investigator hypothesizes that long-term GEMS-H use would improve
locomotor function. Specifically, individuals in the GEMS-H group will show faster gait
speed compared to those in the control group.

Participants will be scheduled for 18 sessions of training (randomly placed either in
GEMS-H training group or traditional training group without the GEM-H) plus 5 sessions of
testing (pre-training, mid-test after the 9 sessions of training, post-training, 1 month
follow-up and 3 month follow-up after the 18 sessions training completed).

with Gait Enhancing and Motivating System-Hip (GEMS-H)

without Gait Enhancing and Motivating System-Hip (GEMS-H)

Measure of self-selected walking speeds by measuring the time it takes a participant to
walk 10 meters. The test is performed using a "flying start," the participant 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."

Measure of fast walking speeds by measuring the time it takes a participant to walk 10
meters. The test is performed using a "flying start," the participant 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 as fast as you can safely when I
say go."

The FGA is used to assess postural stability during walking and assesses a participant's
ability to perform multiple motor tasks while walking. The tool is a modification of the
8-item Dynamic Gait Index, developed to improve reliability and reduce ceiling effect.
Scores of 22/30 on the FGA is effective in predicting falls.

The SPPB is an assessment tool for evaluation of lower extremity function.

The FRT assesses a participant's stability by measuring the maximum distance the
participant can reach forward while standing in a fixed position.

The FSST is used to assess dynamic stability and the ability of the participant to step
over low objects forward, sideways, and backward

The 5XSST is used to assess functional lower extremity strength, transitional movements,
balance, and fall risk. The instructions are: "Please stand up straight as quickly as you
can 5 times, without stopping in between. Keep your arms folded across your chest. I'll
be timing you with a stopwatch. Ready, begin."

The BBS is a 14-item objective measure that assesses static balance and fall risk.

The TUG is a simple test used to assess a participant's mobility and requires both static
and dynamic balance. TUG uses the time that a participant takes to rise from a chair,
walk three meters, turn around, walk back to the chair, and sit down. During the test,
the participant is expected to wear their regular footwear and use any mobility aids that
they would normally require.

Each participant is given an activity monitor band and instructed to wear it on the wrist
during waking hours until completion of the training program (between Visit 2 and Visit
21).

The EQ-5D is a standardized instrument for measuring generic health status. The EQ-5D
questionnaire has two components: health state description and evaluation. In the
description part, health status is measured in terms of five dimensions (5D); mobility,
self-care, usual activities, pain/discomfort, and anxiety/depression. Mobility dimension
asks about the participant's walking ability. Self-care dimension asks about the ability
to wash or dress by oneself, and usual activities dimension measures performance in
"work, study, housework, family or leisure activities". In pain/discomfort dimension, it
asks how much pain or discomfort they have, and in anxiety/depression dimension, it asks
how anxious or depressed they are.

The K-MBI is an ordinal scale used to measure performance in activities of daily living
(ADL). Each performance item is rated on this scale with a given number of points
assigned to each level or ranking. It uses ten variables describing ADL and mobility. A
higher number is associated with a greater likelihood of being able to live at home with
a degree of independence following discharge from hospital.

The FES-K is the measures of "fear of falling" or, more properly, "concerns about
falling", which are suitable for use in research and clinical practice.

The VAS is a pain rating scale. Scores are based on self-reported measures of symptoms
that are recorded with a single handwritten mark placed at one point along the length of
a 10-cm line that represents a continuum between the two ends of the scale; "no pain" on
the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10
cm).

The GDS is a 15-item self-report assessment used to identify depression in the elderly. A
score of 0 to 5 is normal. A score greater than 5 suggests depression.

The maximal isometric strength of the 12 muscles in lower extremity will be measured with
12 channels surface electromyography (NORAXON™, USA).

All participants perform over-ground walking to assess the change of muscle activation
pattern and effort (%MVC) using 12channels surface EMG

All participants perform over-ground walking to assess the change of kinematic (lower
extremity joint angles), kinetics (lower extremity joint moments) and ground reaction
force using motion analysis (Kestrel Digital RealTime System, Motion Analysis
Corporation, USA) and force plate ( TF-4060-B, Tec Gihan Co., Ltd. Japan), respectively.

All participants perform treadmill 6 minute walk test (6MWT) to assess the change of
metabolic energy expenditure using a portable cardiopulmonary metabolic system (Cosmed
K4b², Rome, Italy).

Participants will participate in 18 sessions of training + 5 sessions of testing for up
to 3 month.

Training consists of 15 minutes task-specific training and 30 minutes functional gait
training on varied environments with the device.

Participants will participate in 18 sessions of training + 5 sessions of testing for up
to 3 month.

Training consists of 15 minutes task-specific training and 30 minutes functional gait
training on varied environments without the device.

Effect of GEMS-H on Locomotor Function in Adults

About this trial

Study ID

Status

Type

Phase

Placebo

Accepting

Not accepting

Trial Timing

What is this trial about?

What are the participation requirements?

Locations

Location

Status