Effect of GEMS-H on Locomotor Function in Adults

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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Effect of GEMS-H on Locomotor Function in Adults

Conditions
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Adults, Middle Age, Aged, Aged, 80 and Over

Intervention / Treatment
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* Device: with Gait Enhancing and Motivating System-Hip (GEMS-H)
* Other: without Gait Enhancing and Motivating System-Hip (GEMS-H)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: 19 - 84 years No history of central nervous system related disease Exclusion Criteria: Difficulty in walking due to conditions such as poor vision or fractures Height is less than 140cm or more than 185cm. Body mass index (BMI) greater than 35. Difficulty understanding and participating in the study such as those with cognitive problems or dementia. Subject who is at risk of falling during walking due to severe dizziness

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 84 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Training in the GEMS-H group consists of 15 minutes task-specific training and 30 minutes functional gait training on varied environments with device, whereas training in the control group consists of 15 minutes task-specific training and 30 minutes functional gait training on varied environments without device.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Training with GEMS-H<br>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. | Device: with Gait Enhancing and Motivating System-Hip (GEMS-H)<br>* The intensity of training: between 12 and 16 in borg's rating of perceived exertion scale. Assessments consist of gait function, cardiopulmonary metabolic energy cost, physical performance, balance, physical level, pain, fall efficacy, depression, quality of life and activities of daily living.<br>|
| Active Comparator: Training without GEMS-H<br>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. | Other: without Gait Enhancing and Motivating System-Hip (GEMS-H)<br>* The intensity of training: between 12 and 16 in borg's rating of perceived exertion scale.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 10 Meter Walk Test-Self Selected Velocity (sec) from Baseline to Post-Training Assessment | 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. | Baseline Assessment, Post Training Assessment (6 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 10 Meter Walk Test-Fast Velocity (sec) from Baseline | 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. | Baseline Assessment, Mid Training Assessment (3 weeks), Post Training Assessment (6 weeks), 1 month Post Training Assessment (1 month Follow-up), 3 month Post Training Assessment (3 month Follow-up) | 
| Change in 10 Meter Walk Test-Self Selected Velocity (sec) from Baseline to Other Assessment Time Points | 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. | Baseline Assessment, Mid Training Assessment (3 weeks), 1 month Post Training Assessment (1 month Follow-up), 3 month Post Training Assessment (3 month Follow-up) | 
| Functional Gait Assessment (FGA) | 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. | Baseline Assessment, Mid Training Assessment (3 weeks), Post Training Assessment (6 weeks), 1 month Post Training Assessment (1 month Follow-up), 3 month Post Training Assessment (3 month Follow-up) | 
| Short Physical Performance Battery (SPPB) | The SPPB is an assessment tool for evaluation of lower extremity function. | Baseline Assessment, Mid Training Assessment (3 weeks), Post Training Assessment (6 weeks), 1 month Post Training Assessment (1 month Follow-up), 3 month Post Training Assessment (3 month Follow-up) | 
| Functional Reach Test (FRT) | The FRT assesses a participant's stability by measuring the maximum distance the participant can reach forward while standing in a fixed position. | Baseline Assessment, Mid Training Assessment (3 weeks), Post Training Assessment (6 weeks), 1 month Post Training Assessment (1 month Follow-up), 3 month Post Training Assessment (3 month Follow-up) | 
| Four Square Step Test (FSST) | The FSST is used to assess dynamic stability and the ability of the participant to step over low objects forward, sideways, and backward | Baseline Assessment, Mid Training Assessment (3 weeks), Post Training Assessment (6 weeks), 1 month Post Training Assessment (1 month Follow-up), 3 month Post Training Assessment (3 month Follow-up) | 
| Five times Sit to Stand (5xSST) | 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. | Baseline Assessment, Mid Training Assessment (3 weeks), Post Training Assessment (6 weeks), 1 month Post Training Assessment (1 month Follow-up), 3 month Post Training Assessment (3 month Follow-up) | 
| Berg Balance Scale (BBS) | The BBS is a 14-item objective measure that assesses static balance and fall risk. | Baseline Assessment, Mid Training Assessment (3 weeks), Post Training Assessment (6 weeks), 1 month Post Training Assessment (1 month Follow-up), 3 month Post Training Assessment (3 month Follow-up) | 
| Timed Up and Go test (TUG) | 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. | Baseline Assessment, Mid Training Assessment (3 weeks), Post Training Assessment (6 weeks), 1 month Post Training Assessment (1 month Follow-up), 3 month Post Training Assessment (3 month Follow-up) | 
| Wearable activity tracker (Measurement: Step count, Calorie consumption, and Heart rate) | 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). | Up to Post Training Assessment (Up to 6 weeks) | 
| EuroQol 5 Dimensions (EQ-5D) | 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. | Baseline Assessment, Mid Training Assessment (3 weeks), Post Training Assessment (6 weeks), 1 month Post Training Assessment (1 month Follow-up), 3 month Post Training Assessment (3 month Follow-up)] | 
| Korean-Modified Barthel Index (K-MBI) | 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. | Baseline Assessment, Mid Training Assessment (3 weeks), Post Training Assessment (6 weeks), 1 month Post Training Assessment (1 month Follow-up), 3 month Post Training Assessment (3 month Follow-up) | 
| Fall Efficacy Scale-Korean (FES-K) | 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. | Baseline Assessment, Mid Training Assessment (3 weeks), Post Training Assessment (6 weeks), 1 month Post Training Assessment (1 month Follow-up), 3 month Post Training Assessment (3 month Follow-up) | 
| Visual Analogue Scale (VAS) | 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). | Baseline Assessment, Mid Training Assessment (3 weeks), Post Training Assessment (6 weeks), 1 month Post Training Assessment (1 month Follow-up), 3 month Post Training Assessment (3 month Follow-up) | 
| Geriatric Depression Scale-a short version (GDS-SF) | 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. | Baseline Assessment, Mid Training Assessment (3 weeks), Post Training Assessment (6 weeks), 1 month Post Training Assessment (1 month Follow-up), 3 month Post Training Assessment (3 month Follow-up) | 
| Change in Muscle Strength from Baseline | The maximal isometric strength of the 12 muscles in lower extremity will be measured with 12 channels surface electromyography (NORAXON™, USA). | Baseline Assessment, Post Training Assessment (6 weeks), 1 month Post Training Assessment (1 month Follow-up), 3 month Post Training Assessment (3 month Follow-up) | 
| Change in Muscle Activation Pattern and Effort (%MVC) during Gait from Baseline | All participants perform over-ground walking to assess the change of muscle activation pattern and effort (%MVC) using 12channels surface EMG | Baseline Assessment, Post Training Assessment (6 weeks), 1 month Post Training Assessment (1 month Follow-up), 3 month Post Training Assessment (3 month Follow-up) | 
| Change in Gait Function from Baseline | 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. | Baseline Assessment, Post Training Assessment (6 weeks), 1 month Post Training Assessment (1 month Follow-up), 3 month Post Training Assessment (3 month Follow-up) | 
| Change in Cardiopulmonary Metabolic Energy Consumption from Baseline | 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). | Baseline Assessment, Post Training Assessment (6 weeks), 1 month Post Training Assessment (1 month Follow-up), 3 month Post Training Assessment (3 month Follow-up) |