Gait Pattern Analysis and Feasibility of Gait Training With a Walking Assist Robot in Stroke Patients and Elderly Adults

Healthy Clinical Trial

Official title:

Gait Pattern Analysis and Feasibility of Gait Training With a Newly Developed Walking Assist Robot in Stroke Patients and Elderly Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02843828
• Other study ID #: 2015-05-013-003
• Status: Completed
• Phase: N/A
• Start date: January 2, 2016
• Est. completion date: September 1, 2017

Study information

• Verified date: April 2019
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: September 1, 2017
• Est. primary completion date: August 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 84 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy
• Stroke

Intervention

Device:
• gait rehabilitation with Samsung Hip Assist v1
Participants will participate in 10 sessions of gait rehabilitation with Samsung Hip Assist v1 (5sessions-treadmill gait training / 5sessions-overground gait training), 30min per session

Other:
• gait rehabilitation without Samsung Hip Assist v1
Participants will participate in 10 sessions of gait rehabilitation without Samsung Hip Assist v1 (5sessions-treadmill gait training / 5sessions-overground gait training), 30min per session

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Samsung Medical Center	Samsung Electronics

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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."	session 0 (initial visit); session 11 (at approximately 4 weeks)
Secondary	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.	session 0 (initial visit); session 11 (at approximately 4 weeks)
Secondary	Tinetti performance oriented mobility assessment (POMA)	Task-oriented outcome measure that assesses gait and balance ability is composed of a 9-item gait portion (POMA-G) and 7-item balance portion (POMA-B).	session 0 (initial visit); session 11 (at approximately 4 weeks)
Secondary	Modified Bathel index (MBI)	The MBI is a measure of activities of daily living, which shows the degree of independence of a patient from any assistance. It covers 10 domains of functioning (activities): bowel control, bladder control, as well as help with grooming, toilet use, feeding, transfers, walking, dressing, climbing stairs, and bathing.	session 0 (initial visit); session 11 (at approximately 4 weeks)
Secondary	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.	session 0 (initial visit); session 11 (at approximately 4 weeks)
Secondary	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.	session 0 (initial visit); session 11 (at approximately 4 weeks)
Secondary	Fugl-Meyer assessment for lower extremity (FMA)	The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment.	session 0 (initial visit); session 11 (at approximately 4 weeks)
Secondary	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.	session 0 (initial visit); session 11 (at approximately 4 weeks)
Secondary	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.	session 0 (initial visit); session 11 (at approximately 4 weeks)
Secondary	Range of Motion (ROM)	Range of Motion (ROM) testing is the measurement of movement around a specific joint or body part.	session 0 (initial visit); session 11 (at approximately 4 weeks)