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

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Samsung Medical Center

Status

Completed

Conditions

Healthy
Stroke

Treatments

Device: gait enhancing mechatronic system (GEMS)
Procedure: Sit-to-stand movement and treadmill gait
Procedure: Gait, sit-to-stand movement, stair climbing and treadmill gait
Device: treadmill

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT03048968
2016-07-093

Details and patient eligibility

About

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.

Full description

In elderly adults, 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. 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. In stroke patients, 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.

Enrollment

40 patients

Sex

All

Ages

20 to 84 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

study group1: elderly adults
Experimental group
Description:
Gait, sit-to-stand movement, stair climbing and treadmill gait with GEMS and without GEMS
Treatment:
Device: treadmill
Procedure: Gait, sit-to-stand movement, stair climbing and treadmill gait
Device: gait enhancing mechatronic system (GEMS)
study group2: stroke patients
Experimental group
Description:
Sit-to-stand movement and treadmill gait with GEMS and without GEMS
Treatment:
Device: treadmill
Procedure: Sit-to-stand movement and treadmill gait
Device: gait enhancing mechatronic system (GEMS)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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