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

NCT ID: NCT02843828

Last Updated: 2019-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-02
• Study Completion Date: 2017-09-01

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).

Conditions

Stroke; Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Samsung Hip Assist v1

gait rehabilitation with Samsung Hip Assist v1 10 sessions (5sessions - treadmill gait training / 5sessions - overground gait training), 30 min per session

Group Type: EXPERIMENTAL

gait rehabilitation with Samsung Hip Assist v1

Intervention Type: DEVICE

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

Conventional gait training

gait rehabilitation without Samsung Hip Assist v1 10 sessions (5sessions - treadmill gait training / 5sessions - overground gait training), 30 min per session

Group Type: ACTIVE_COMPARATOR

gait rehabilitation without Samsung Hip Assist v1

Intervention Type: OTHER

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

Interventions

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

Intervention Type: DEVICE

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 84 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samsung Electronics

INDUSTRY

Sponsor Role: collaborator

Samsung Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Yun-Hee Kim

Professor, MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yun-Hee Kim, MD, PhD

Role: STUDY_CHAIR

Samsung Medical Center

Locations

Samsung Medical Center

Seoul, , South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 31623545 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29183379 (View on PubMed)

Other Identifiers

2015-05-013-003

Identifier Type: -

Identifier Source: org_study_id