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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-01

Study Completion Date

2017-10-23

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Stroke Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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study group1: elderly adults

Gait, sit-to-stand movement, stair climbing and treadmill gait with GEMS and without GEMS

Group Type EXPERIMENTAL

Gait, sit-to-stand movement, stair climbing and treadmill gait

Intervention Type PROCEDURE

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.

gait enhancing mechatronic system (GEMS)

Intervention Type DEVICE

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.

treadmill

Intervention Type DEVICE

Cortical activation is measured by functional Near-Infrared-Spectroscopy (fNIRS) (NIRScout, NIRx, Germany) during treadmill gait.

study group2: stroke patients

Sit-to-stand movement and treadmill gait with GEMS and without GEMS

Group Type EXPERIMENTAL

Sit-to-stand movement and treadmill gait

Intervention Type PROCEDURE

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 enhancing mechatronic system (GEMS)

Intervention Type DEVICE

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.

treadmill

Intervention Type DEVICE

Cortical activation is measured by functional Near-Infrared-Spectroscopy (fNIRS) (NIRScout, NIRx, Germany) during treadmill gait.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

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.

Intervention Type DEVICE

treadmill

Cortical activation is measured by functional Near-Infrared-Spectroscopy (fNIRS) (NIRScout, NIRx, Germany) during treadmill gait.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

84 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No