Clinical trial NCT02843828: Gait Pattern Analysis and Feasibility of Gait Training With a Walking Assist Robot in Stroke Patients and Elderly Adults
Official title: Gait Pattern Analysis and Feasibility of Gait Training With a Newly Developed Walking Assist Robot in Stroke Patients and Elderly Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Healthy
Keywords: Exoskeleton Device
elderly
stroke
gait rehabilitation
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Samsung Electronics
First posted: 2016-07-26
Enrollment: 56
Sex: ALL
Minimum age (years): 50
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to investigate the effects of the new wearable hip assist robot developed by Samsung Advanced Institute of Technology (Samsung Electronics Co, Ltd., Korea) to gait rehabilitation in elderly adults and stroke patients.

Detailed description: Randomized, two treatment groups

Number of Subjects : 54 subjects (n=27 per group)

Group 1 : gait rehabilitation with hip assist robot / 10 sessions (5sessions - treadmill gait training / 5sessions - overground gait training), 30min per session

Group 2 : gait rehabilitation without hip assist robot / 10 sessions (5sessions - treadmill gait training / 5sessions - overground gait training), 30min per session

Primary objective is to demonstrate the effects of hip assist robot on spatio-temporal parameters measured by motion capture system (Motion Analysis Corporation, Santa Rosa, CA, USA), muscle activation patterns measured by surface electromyography (sEMG) (Noraxon Inc., Scottsdale, AZ, USA), metabolic energy cost parameters measured by portable cardiopulmonary metabolic system (Cosmed K4B2, Rome, Italy) and foot pressure distribution measured by F-Scan Mobile system (Tekscan Inc., South Boston, MA, USA).

Secondary objective is to demonstrate the effects of hip assist robot on motor function improvement evaluated by Berg Balance Scale (BBS), Tinetti performance oriented mobility assessment (POMA), Korean version Modified Bathel index (K-MBI), Modified Rankin Scale (MRS), Functional Ambulation Classification (FAC), Fugl-Meyer assessment for lower extremity (FMA), Korean version Fall Efficacy Scale (K-FES), Manual Muscle Test (MMT) and Range of Motion (ROM).

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
  4. High levels of physical performance (SPPB \> 7)
  5. Subject is willing to be randomized to the control group or the treatment group
* Stroke

  1. Age: between 50 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
  6. Subject is willing to be randomized to the control group or the treatment group

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: Change in 10 meter walk test from baseline in gait speed
timeFrame: session 0 (initial visit); session 11 (at approximately 4 weeks)
Secondary outcomes:
measure: Berg Balance Scale (BBS)
timeFrame: session 0 (initial visit); session 11 (at approximately 4 weeks)
measure: Tinetti performance oriented mobility assessment (POMA)
timeFrame: session 0 (initial visit); session 11 (at approximately 4 weeks)
measure: Modified Bathel index (MBI)
timeFrame: session 0 (initial visit); session 11 (at approximately 4 weeks)
measure: Modified Rankin Scale (MRS)
timeFrame: session 0 (initial visit); session 11 (at approximately 4 weeks)
measure: Functional Ambulation Classification (FAC)
timeFrame: session 0 (initial visit); session 11 (at approximately 4 weeks)
measure: Fugl-Meyer assessment for lower extremity (FMA)
timeFrame: session 0 (initial visit); session 11 (at approximately 4 weeks)
measure: Fall Efficacy Scale (FES)
timeFrame: session 0 (initial visit); session 11 (at approximately 4 weeks)
measure: Manual Muscle Test (MMT)
timeFrame: session 0 (initial visit); session 11 (at approximately 4 weeks)
measure: Range of Motion (ROM)
timeFrame: session 0 (initial visit); session 11 (at approximately 4 weeks)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Yun-Hee Kim, MD, PhD
role: STUDY_CHAIR
References:
citation: Lee HJ, Lee SH, Seo K, Lee M, Chang WH, Choi BO, Ryu GH, Kim YH. Training for Walking Efficiency With a Wearable Hip-Assist Robot in Patients With Stroke: A Pilot Randomized Controlled Trial. Stroke. 2019 Dec;50(12):3545-3552. doi: 10.1161/STROKEAHA.119.025950. Epub 2019 Oct 18.
citation: Lee SH, Lee HJ, Chang WH, Choi BO, Lee J, Kim J, Ryu GH, Kim YH. Gait performance and foot pressure distribution during wearable robot-assisted gait in elderly adults. J Neuroeng Rehabil. 2017 Nov 28;14(1):123. doi: 10.1186/s12984-017-0333-z.