Clinical trial NCT03048968: The Effect of a Walking Assist Robot on Gait Function and Brain Activity in Stroke Patients and Elderly Adults
Official title: The Effect of a Walking Assist Robot on Gait Function and Brain Activity in Stroke Patients and Elderly Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Healthy
Keywords: Exoskeleton Device
elderly
stroke
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Samsung Electronics
First posted: 2017-02-09
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cortical activation
timeFrame: 30minutes
Secondary outcomes:
measure: Berg Balance Scale (BBS)
timeFrame: 30minutes
measure: Fall Efficacy Scale (FES)
timeFrame: 20minutes
measure: Manual Muscle Test (MMT)
timeFrame: 20minutes
measure: Range of Motion (ROM)
timeFrame: 20minutes
measure: Functional Ambulation Classification (FAC)
timeFrame: 20minutes
measure: The modified Rankin Scale (mRS)
timeFrame: 20minutes
measure: Change in 10 meter walk test from baseline in gait speed
timeFrame: 1hour
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Yun-Hee Kim
role: STUDY_CHAIR
References:
citation: 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.