The Effect of a Walking Assist Robot on Gait Function and Brain Activity in Stroke Patients and Elderly Adults
1 other identifier
interventional
40
1 country
1
Brief Summary
The purpose of this study was to investigate the effects of the new wearable hip assist robot, gait enhancing and motivating system (GEMS) developed by Samsung Advanced Institute of Technology (Samsung Electronics Co, Ltd., Korea) on gait, sit-to-stand movement and cortical activation in elderly adults and stroke patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable stroke
Started Mar 2017
Shorter than P25 for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 6, 2017
CompletedFirst Posted
Study publicly available on registry
February 9, 2017
CompletedStudy Start
First participant enrolled
March 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 23, 2017
CompletedApril 29, 2019
April 1, 2019
7 months
February 6, 2017
April 25, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cortical activation
Cortical activation is measured by functional Near-Infrared-Spectroscopy (fNIRS) (NIRScout, NIRx, Germany) during treadmill gait.
30minutes
Secondary Outcomes (7)
Berg Balance Scale (BBS)
30minutes
Fall Efficacy Scale (FES)
20minutes
Manual Muscle Test (MMT)
20minutes
Range of Motion (ROM)
20minutes
Functional Ambulation Classification (FAC)
20minutes
- +2 more secondary outcomes
Study Arms (2)
study group1: elderly adults
EXPERIMENTALGait, sit-to-stand movement, stair climbing and treadmill gait with GEMS and without GEMS
study group2: stroke patients
EXPERIMENTALSit-to-stand movement and treadmill gait with GEMS and without GEMS
Interventions
Spatio temporal characteristics, muscle activation and foot pressure distribution are measured by motion capture system, surface electromyography (sEMG) and F-Scan Mobile system during 10m walking test. Muscle activation and foot pressure distribution are measured by surface electromyography (sEMG) and F-Scan Mobile system during five times sit-to-stand test.Muscle activation and foot pressure distribution are measured by surface electromyography (sEMG) and F-Scan Mobile system during stair climbing. Cortical activation is measured by functional Near-Infrared-Spectroscopy (fNIRS) (NIRScout, NIRx, Germany) during treadmill gait.
Muscle activation and foot pressure distribution are measured by surface electromyography (sEMG) and F-Scan Mobile system during five times sit-to-stand test. Cortical activation is measured by functional Near-Infrared-Spectroscopy (fNIRS) (NIRScout, NIRx, Germany) during treadmill gait.
Gait, sit-to-stand movement, stair climbing and treadmill gait with GEMS and without GEMS in elderly adults. Sit-to-stand movement and treadmill gait with GEMS and without GEMS in stroke patients.
Cortical activation is measured by functional Near-Infrared-Spectroscopy (fNIRS) (NIRScout, NIRx, Germany) during treadmill gait.
Eligibility Criteria
You may qualify if:
- Elderly adults
- 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
- Stroke
- Age: between 20 and 84 years
- ≥ 3 months post stroke
- Ability to walk at least 10m regardless of assist devices
- Adequate gait function (FAC \> 3)
- Physician approval for patient participation
You may not qualify if:
- Elderly adults
- 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
- Stroke
- Serious cardiac conditions (hospitalization for myocardial infarction or heart surgery within 3 months, history of congestive heart failure, documented serious and unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living)
- Advanced liver, kidney, cardiac, or pulmonary disease
- History of concussion in last 6 months
- History of unexplained, recurring headaches, epilepsy/seizures/skull fractures or skull deficits
- Preexisting neurological disorders such as Parkinson's disease, Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), dementia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Samsung Medical Centerlead
- Samsung Electronicscollaborator
Study Sites (1)
Samsung Medical Center
Seoul, South Korea
Related Publications (1)
Lee SH, Lee HJ, Shim Y, Chang WH, Choi BO, Ryu GH, Kim YH. Wearable hip-assist robot modulates cortical activation during gait in stroke patients: a functional near-infrared spectroscopy study. J Neuroeng Rehabil. 2020 Oct 29;17(1):145. doi: 10.1186/s12984-020-00777-0.
PMID: 33121535DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Yun-Hee Kim
Samsung Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, MD, PhD
Study Record Dates
First Submitted
February 6, 2017
First Posted
February 9, 2017
Study Start
March 1, 2017
Primary Completion
September 30, 2017
Study Completion
October 23, 2017
Last Updated
April 29, 2019
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will not share