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.

Locomotion training using voluntary driven exoskeleton (HAL) in acute incomplete SCI

1. Oliver Cruciger, MD, 
2. Martin Tegenthoff, MD, 
3. Peter Schwenkreis, MD, 
4. Thomas A. Schildhauer, MD and 
5. Mirko Aach, MD

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1. Correspondence to Dr. Cruciger: oliver.cruciger@bergmannsheil.de

1. doi: 10.1212/WNL.0000000000000645Neurology July 29, 2014 vol. 83 no. 5 474

http://www.neurology.org/content/83/5/474.full

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A 34-year-old man had a traumatic thoracic spinal cord injury, with vertebral fracture and a right acetabulum fracture. Dorsal spinal fusion of T6 through T9 was performed on admission. The initial American Spinal Injury Association (ASIA) Impairment Scale (C) showed incomplete motor T10 lesion.

Exoskeletal locomotion training with hybrid assistive limb¹ started 77 days post trauma after radiologic confirmation of consolidation of the acetabulum fracture.

There was recovery of motor functions and walking abilities (video 1 on the Neurology® Web site at Neurology.org) throughout 12 weeks of locomotion training² with an increase in Walking Index for Spinal Cord Injury II (WISCI-II) score from 8 to 18 (video 2); conversion to ASIA D occurred.

 

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FOOTNOTES

• Supplemental data at Neurology.org
• Author contributions: Dr. Cruciger: concept, acquisition and data, design and analysis. Prof. Dr. Schwenkreis: critical revision of the manuscript, supervision. Prof. Dr. Tegenthoff: critical revision of the manuscript, supervision. Prof. Dr. Schildhauer: critical revision of the manuscript, supervision. Dr. Aach: concept, design, acquisition and data, supervision.
• Study funding: No targeted funding reported.
• Disclosure: The authors report no disclosures relevant to the manuscript. Go to Neurology.org for full disclosures.

• © 2014 American Academy of Neurology

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REFERENCES

1. 1.↵
    

   1. Kubota S, 
   2. Nakata Y, 
   3. Eguchi K, 
   4. et al

   . Feasibility of rehabilitation training with a newly developed wearable robot for patients with limited mobility. Arch Phys Med Rehabil 2013;94:1080–1087.

    

   MedlineGoogle Scholar
2. 2.↵
    

   1. Schwartz I, 
   2. Sajina A, 
   3. Neeb M, 
   4. Fisher I, 
   5. Katz-Luerer M, 
   6. Meiner Z

   . Locomotor training using a robotic device in patients with subacute spinal cord injury. Spinal Cord 2011;49:1062–1067.

    

   CrossRefMedlineGoogle Scholar

HAL® Therapy

HAL® Therapy is the medical service with Robot Suit HAL® to provide medical treatments for functional improvement of patients with cerebral, nervous and muscle disorders including spinal cord injury and cerebral embolism.

HAL® [Hybrid Assistive Limb®] is the world‘s first*1 cyborg-type robot, by which a wearer‘s bodily functions can be improved, supported and enhanced.

Wearing of HAL® leads to a fusion of “man”, “machine” and “information”. HAL® assists a physically challenged person to move and enables him or her to exert bigger motor energy than usual. HAL®is also considered as the system that accelerates a motor learning of cerebral nerves.

http://www.cyberdyne.jp/

When a person intends to move his or her body, nerve signals are transmitted from the brain to muscles via motor neurons and then, a musculoskeletal system such as a joint moves. At that time, subtle “bio-electric signals [BES]” leaks out onto the human skin, which reflects his or her intention to “move”. HAL® that reads BES and controls a power unit is able to assist the joint’s movement in harmony with the person.
There is a hypothesis: When a patient use Robot Suit HAL® that provides motion assistance in line with BES as a reflection of motion intention, by the intermediation of HAL®, interactive Bio-Feedback [hereinafter “iBF”] is prompted among HAL®, the cerebral/nervous system and the muscular system via or outside the human body. BY “iBF”, functions of patients with cerebral/nervous system and the muscular system disorders, which had increased due to aging society, would hypothetically be reduced. Based on this “iBF” hypothesis, via clinical application, possibility of functional improvement in human walking is getting confirmed. In other words, not only the motion caused by the transmission of spontaneous command signal “I want to move!” from the human brain to the musculoskeletal system via the spinal cord and peripheral nerves, but also feedback of the actual feeling “I could move!” to the brain are the important keys to accelerate functional improvements.
Treatments for functional improvements and functional regeneration are kinds of new robot therapies, which aim at improvement of motor functions using HAL® based upon the above-mentioned “iBF” hypothesis.

CYBERDYNE Inc. and it’s business partner, Berufsgenossenschaft Rohstoffe und chemissche Industrie [Professional Association of Raw Materials and Chemical Industry, hereinafter BG RCI] in Germany, jointly established Cyberdyne Care Robotics GmbH in Bochum, Nordrhein-Westfalen [hereinafter “NRW”], Germany, which aimed at treatment for functional improvement of patients with cerebral, nervous and muscular system disorders including spinal injury and cerebral embolism. This is the great step of the Japanese most-advanced robotic remedial device in the world and treatment for functional improvement utilizing Robot Suit HAL® toward the internationally recognized medical technology and therapeutic measure. Robot Suit HAL® that is developed, manufactured and marketed by CYBERDYNE Inc. was accredited Certification of conformity to Medical Device Directive [hereinafter MDD] of EC for the first time in the world as a robotic remedial device* by the EC’s largest notified body. This enables CYBERDYNE Inc. to indicate CE Marking for Medical Device, which requires periodic examination, on Robot Suit HAL®, for distributing and marketing it as a medical device in the whole EU region.
*Announcement was made in Japan and Germany on August 5th, 2013.
In view of various insurance applications in the whole EU region, dissemination of treatment with HAL® is expected.
It is notable that Deutsche Gesetzliche Unfallversicherung [German Statutory Accident Insurance, hereinafter “DGUV”] decided to apply workman’s accident compensation insurance to the treatment for functional improvement utilizing Robot Suit HAL®, which is managed by the joint venture company. The fee* for medical treatment with HAL®, of which one time fee is €500 and number of times is up to 60 plus additional treatment, is fully covered by the compensation insurance. CYBERDYNE Inc. and the joint venture in cooperation with New Energy and Industrial Technology Development Organization [hereinafter “NEDO”] of Japan, the state of NRW, BG Bergmannsheil Hospital, Germany, University of Tsukuba, Japan, in order to contribute to the society widely, pursue various possibilities of HAL® and promote practical materialization of it in the society, are going to proceed verification tests of HAL®.

■From a wheelchair to a walker

Philippe von Gliszynski fell 3m from a roof when he was removing snow. His body below the 12th thoracic spine got paralyzed. Though he had a little sensation in his left leg, after one time surgery and regular rehabilitation, he should prepare himself for a wheelchair-bound life. He participated the clinical test for functional improvement with HAL® in February, 2012. At that time, it took 72 seconds for him to walk 10m with a walker but, in June, his symptom was so improved that it took only 26 seconds. After training he became able to walk more than 1,000m with a walker without being assisted by HAL®. Nobody could imagine that at the start of treatment with HAL®.

In 2013, Cyberdyne Care Robotics GmbH is providing the treatment with HAL®. With regard to details, refer to information of each center.

The world’s first, robotic remedial device that lead to the possibility to walk

http://www.cyberdyne.jp/

HAL^®for Medical Use - Lower Limb Model [European Model] is the medical device for people who have disorders in the lower

limb and people whose legs are weakening.

*The device obtained CE Marking [CE 0197] for the first time as a robotic medical device. HAL® for Medical Use was certified its conformity to the requirements of Medical Device Directives in EU.

*The device has not yet been certified as a medical device in japan.

CYBERDYNE Inc. received the certificate of ISO13485 (Medical Device) for the first time as a robotic medical device manufacturer.

HAL® [Hybrid Assistive Limb®] is the world‘s first*1 cyborg-type robot, by which a wearer‘s bodily functions can be improved, supported and enhanced.

Wearing of HAL® leads to a fusion of “man”, “machine” and “information”. HAL® assists a physically challenged person to move and enables him or her to exert bigger motor energy than usual. HAL®is also considered as the system that accelerates a motor learning of cerebral nerves.

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Major causes of lower limb disabilities are disorders of the cerebral and nervous muscular system. In those cases, the brain cannot use ordinary neural pathways and cannot order to move the legs.
HAL® for Medical Use - Lower Limb Model moves the wearer’s legs in accordance with the wearer’s intention, “I want to walk.” or “I want to stand up.”, and enables timely feedback of the feelings, “I could walk.” or “I could stand up.”. Consequently, this accelerates the learning by the brain.
HAL® for Medical Use - Lower Limb Model is the only robotic remedial device that can teach the brain how to move the legs. 

HAL® for Medical Use - Lower Limb Model is applicable as a medical device in EU to patients of Musculoskeletal Ambulation Disability Symptom Complex [= MADS], who suffer from spinal cord injuries, traumatic brain injuries, cerebrovascular diseases, diseases of the brain and neuromuscular system, etc.

HAL® for Medical Use - Lower Limb Model that sufficiently has adjustable elements to wearers’ various constitutions can fit to their leg lengths, hip widths and foot sizes in wide ranges. With its seamless adjustment mechanism, HAL® can embrace the wearer’s body.

When a person moves the body, various signals are sent from the brain to muscles through nerves. Those Signals leak on the skin surface as “bio-electric signals [BES]”. HAL® for Medical Use - Lower Limb Model reads the wearer’s BES, accordingly compensates muscle power of lower limbs and assists him or her in walking, standing-up and sitting-down with his or her own legs.

With the freely detachable controller of HAL®, the operator can manipulate all the operations, such as start/stop of assistance, alteration of settings and confirmation of motion statuses, closely watching the move of the wearer. Tailor-made assistance for individual wearers makes training with HAL® for Medical Use - Lower Limb Model more effective.

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HAL® for Medical Use - Lower Limb Model [European Model] is only handled in Germany. Contact the following with regard to inquiries about the training with HAL®.