Feasibility of Rehabilitation Training With a Newly Developed Wearable Robot for Patients With Limited Mobility 

• Shigeki Kubota, MS, OT^a, 
• Yoshio Nakata, PhD^b, c, 
• Kiyoshi Eguchi, MD, PhD^b, , , 
• Hiroaki Kawamoto,PhD^d, 
• Kiyotaka Kamibayashi, PhD^d, 
• Masataka Sakane, MD, PhD^b, c, 
• Yoshiyuki Sankai, PhD^d, 
• Naoyuki Ochiai, MD, PhD^b, c

• ^a Graduate School of Comprehensive Human Sciences, University of Tsukuba, Ibaraki, Japan
• ^b Faculty of Medicine, University of Tsukuba, Ibaraki, Japan
• ^c Tsukuba Critical Path Research and Education Integrated Leading Center (CREIL), University of Tsukuba, Ibaraki, Japan
• ^d Faculty of Systems and Information Engineering, University of Tsukuba, Ibaraki, Japan

Abstract

Objective

To investigate the feasibility of rehabilitation training with a new wearable robot.

Design

Before-after clinical intervention.

Setting

University hospital and private rehabilitation facilities.

Participants

A convenience sample of patients (N=38) with limited mobility. The underlying diseases were stroke (n=12), spinal cord injuries (n=8), musculoskeletal diseases (n=4), and other diseases (n=14).

Interventions

The patients received 90-minute training with a wearable robot twice per week for 8 weeks (16 sessions).

Main Outcome Measures

Functional ambulation was assessed with the 10-m walk test (10MWT) and the Timed Up & Go (TUG) test, and balance ability was assessed with the Berg Balance Scale (BBS). Both assessments were performed at baseline and after rehabilitation.

Results

Thirty-two patients completed 16 sessions of training with the wearable robot. The results of the 10MWT included significant improvements in gait speed, number of steps, and cadence. Although improvements were observed, as measured with the TUG test and BBS, the results were not statistically significant. No serious adverse events were observed during the training.

Conclusions

Eight weeks of rehabilitative training with the wearable robot (16 sessions of 90min) could be performed safely and effectively, even many years after the subjects received their diagnosis.

Keywords

• Feasibility studies; 
• Mobility limitation; 
• Orthopedic equipment; 
• Rehabilitation; 
• Robotics

List of abbreviations

• BBS, Berg Balance Scale; 
• CAC, cybernic autonomous control; 
• CVC, cybernic voluntary control; 
• HAL,hybrid assistive limb; 
• MADS, musculoskeletal ambulation disability symptom complex; 
• SCI, spinal cord injury; 
• 10MWT, 10-m walk test; 
• TUG, Timed Up & Go

Supported by the “Center for Cybernics Research–World Leading Human-Assistive Technology Supporting a Long-Lived and Healthy Society,” granted through “Funding Program for World-Leading Innovative R&D on Science and Technology (FIRST Program),” initiated by the Council for Science and Technology Policy.

A commercial party having a direct financial interest in the results of the research supporting this article has conferred or will confer a financial benefit on 1 or more of the authors. Yoshiyuki Sankai is CEO of Cyberdyne Inc, Ibaraki, Japan. Hiroaki Kawamoto is a stockholder of the company. Cyberdyne is the manufacturer of the robot suit HAL. This study was proposed by the authors. Cyberdyne was not directly involved in the study design; collection, analysis, or interpretation of data; writing the report; or the decision to submit the paper for publication.

No commercial party having a direct financial interest in the results of the research supporting this article has or will confer a benefit on the authors or on any organization with which the authors are associated (Kubota, Nakata, Eguchi, Kamibayashi, Sakane, Ochiai).

Clinical Trial Registry Number: UMIN000002969.

Corresponding author: Kiyoshi Eguchi, MD, PhD, Associate Professor, Dept of Rehabilitation Medicine, Faculty of Medicine, University of Tsukuba, 1-1-1 Tennodai, Tsukuba, Ibaraki 305-8575, Japan.