The Effect of a Walking Assist Robot on Gait Function and Brain Activity in Stroke Patients and Elderly Adults

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Healthy
• Intervention / Treatment: Procedure: Gait, sit-to-stand movement, stair climbing and treadmill gait; Device: gait enhancing mechatronic system (GEMS); Device: treadmill; Procedure: Sit-to-stand movement and treadmill gait

Detailed Description

In elderly adults,

1. Spatio temporal characteristics, muscle activation and foot pressure distribution are measured by motion capture system (Motion Analysis Corporation, Santa Rosa, CA, USA), surface electromyography (sEMG) (Noraxon Inc., Scottsdale, AZ, USA) and F-Scan Mobile system (Tekscan Inc., South Boston, MA, USA) during 10m walking test.
2. Muscle activation and foot pressure distribution are measured by surface electromyography (sEMG) and F-Scan Mobile system during five times sit-to-stand test.
3. Muscle activation and foot pressure distribution are measured by surface electromyography (sEMG) and F-Scan Mobile system during stair climbing.
4. Cortical activation is measured by functional Near-Infrared-Spectroscopy (fNIRS) (NIRScout, NIRx, Germany) during treadmill gait.

In stroke patients,

1. Muscle activation and foot pressure distribution are measured by surface electromyography (sEMG) and F-Scan Mobile system during five times sit-to-stand test.
2. Cortical activation is measured by functional Near-Infrared-Spectroscopy (fNIRS) (NIRScout, NIRx, Germany) during treadmill gait.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 84 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Elderly adults

  1. Age: between 65 and 84 years
  2. elderly adults who had no neurological or musculoskeletal abnormalities affecting gait
  3. Ability to walk at least 10m regardless of assist devices

• Stroke

  1. Age: between 20 and 84 years
  2. ≥ 3 months post stroke
  3. Ability to walk at least 10m regardless of assist devices
  4. Adequate gait function (FAC > 3)
  5. Physician approval for patient participation

Exclusion Criteria:

• Elderly adults

  1. History of any diseases (eg. lower extremity orthopedic diseases, neurologic disorders, cardiovascular disease, heart failure, uncontrolled hypertension that affect walking capacity, efficiency, and endurance)
  2. Severe visual impairment or dizziness that increases the risk of falls

• Stroke

  1. 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)
  2. Advanced liver, kidney, cardiac, or pulmonary disease
  3. History of concussion in last 6 months
  4. History of unexplained, recurring headaches, epilepsy/seizures/skull fractures or skull deficits
  5. Preexisting neurological disorders such as Parkinson's disease, Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), dementia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: study group1: elderly adults; Gait, sit-to-stand movement, stair climbing and treadmill gait with GEMS and without GEMS	Procedure: Gait, sit-to-stand movement, stair climbing and treadmill gait; 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.; Device: gait enhancing mechatronic system (GEMS); 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.; Device: treadmill; Cortical activation is measured by functional Near-Infrared-Spectroscopy (fNIRS) (NIRScout, NIRx, Germany) during treadmill gait.
Experimental: study group2: stroke patients; Sit-to-stand movement and treadmill gait with GEMS and without GEMS	Device: gait enhancing mechatronic system (GEMS); 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.; Device: treadmill; Cortical activation is measured by functional Near-Infrared-Spectroscopy (fNIRS) (NIRScout, NIRx, Germany) during treadmill gait.; Procedure: Sit-to-stand movement and 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cortical activation	Cortical activation is measured by functional Near-Infrared-Spectroscopy (fNIRS) (NIRScout, NIRx, Germany) during treadmill gait.	30minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Berg Balance Scale (BBS)	The BBS is a 14-item objective measure designed to assess static balance and fall risk in adult populations and is a well-accepted measure in the stroke literature. The functional activities that are assessed include sitting and standing balance during transfers, altered base of support, reaching, turning, eyes open and closed.	30minutes
Fall Efficacy Scale (FES)	Fall Efficacy Scale (FES) is a 10-item questionnaire designed confidence in their ability to perform 10 daily tasks without falling as an indicator of how one's fear of falling impacts physical performance. Each item is rated from 1 ("very confident") to 10 ("not confident at all"), and the per item ratings are added to generate a summary total score.	20minutes
Manual Muscle Test (MMT)	Manual muscle testing (MMT) is a procedure for the evaluation of the function and strength of individual muscles and muscle groups based on the effective performance of a movement in relation to the forces of gravity and manual resistance.	20minutes
Range of Motion (ROM)	Range of Motion (ROM) testing is the measurement of movement around a specific joint or body part.	20minutes
Functional Ambulation Classification (FAC)	The Functional Ambulation Categories (FAC) is a functional walking test that evaluates ambulation ability. This 6-point scale assesses ambulation status by determining how much human support the patient requires when walking, regardless of whether or not they use a personal assistive device.	20minutes
The modified Rankin Scale (mRS)	The modified Rankin Scale (mRS) is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability.	20minutes
Change in 10 meter walk test from baseline in gait speed	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."	1hour

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Collaborators: Samsung Electronics
• Investigators: Study Chair: Yun-Hee Kim, Samsung Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Actual): September 30, 2017
• Study Completion (Actual): October 23, 2017

Study Registration Dates

• First Submitted: February 6, 2017
• First Submitted That Met QC Criteria: February 8, 2017
• First Posted (Estimate): February 9, 2017

Study Record Updates

• Last Update Posted (Actual): April 29, 2019
• Last Update Submitted That Met QC Criteria: April 25, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: stroke; elderly; Exoskeleton Device
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 2016-07-093

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No