PROSPECTIVE CLINICAL TRIAL OF A NOVEL TECHNOLOGY COMBINATION THERAPY FOR SENSORIMOTOR DEFICIT OF UPPER EXTREMITY IN PATIENTS WITH CHRONIC STROKE

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Kaneko F1,2, Shindo K1,2, Okawada M1,2, Yoneta M1,2,3, Akaboshi K1,2, Kawakami M1, Mizuno K1, Tsuji T1, Ushiba J4, Liu M1
1Keio University School of Medicine, Department of Rehabilitation Medicine, Tokyo, Japan, 2Shonan Keiiku Hospital, Department of Rehabilitation, Fujisawa, Japan, 3Keio University Graduate School of Medicine, Department of Rehabilitation Medicine, Tokyo, Japan, 4Keio University Faculty of Science and Technology, Department of Biosciences and Informatics, Yokohama, Japan

Background: Effective therapeutic approaches to improve sensorimotor function in severely paralyzed stroke patients have not been established with high-quality evidence (Pollock, 2014). However, there are several candidate therapeutic approaches: motor imagery, mirror therapy, brain-machine interface (BMI) therapy, and virtual reality.
Importantly, we have developed a system that provides kinesthetic illusion induced by visual stimulation (KiNvis). Kinesthetic illusion enables a resting subject to feel as if he/she is moving his/her own body part. We previously reported cerebral network activity associated with KiNvis (Kaneko, 2015) and enhancement of primary motor cortex excitability (Kaneko, 2007) as results of non-clinical phase investigations; there were immediately observable clinical effects (Kaneko, 2016). Through several analyses, we considered the potential of KiNvis as a therapeutic approach for patients with stroke. Furthermore, BMI technology may serve as an effective tool to strengthen damaged neural pathways or induce cortical plasticity (Ushiba & Soekadar, 2016); there is extensive evidence supporting the use of BMI therapy for patients with stroke, including clinical research from our department (Ono, 2014; Mukaion, 2014; Nishimoto, 2018). KiNvis therapy induces short-term enhancement of primary motor cortex excitability and kinesthetic perception caused by repetitive movements of digital images from a first-person perspective. Thus, we estimated the effectiveness of applying KiNvis before BMI therapy in a series of therapeutic approaches during a single day.

Purpose: The purpose of the present study was to explore the effect of the combined approach of our novel technology with conventional therapeutic exercises on sensorimotor deficit in stroke patients.

Methods: Thirteen patients (16-65 years old) participated. All patients exhibited severely impaired motor and/or sensory function, stroke impairment assessment set of finger function indicated 1A for all participants. The Institutional Ethics Committee of the Hospital approved the study, and all patients provided written informed consent prior to participation. We applied a therapeutic package, which comprised of KiNvis therapy with neuromuscular electrical stimulation, BMI therapy, and upper extremity exercise for a total of 10 days. All patients underwent assessment of their sensorimotor function by using the Fugl-Meyer Score (FMA), modified Ashworth scale (MAS), sensory examination (kinesthesia, tactile, two-point discrimination) before and after the treatment package.

Results: FMA upper extremity total score was significantly increased after the intervention (p = 0.001). Specifically, scores in the “Shoulder/Elbow/Forearm” item showed changes after the treatment. MAS showed significant improvement in the elbow flexors (p = 0.001), wrist flexors (p = 0.011), and 2nd to 5th finger flexors (p=0.005) items. Assessments of sensory function did not show any significant change.

Conclusion(s): The results of the present study indicated that combined KiNvis and BMI therapy positively affected motor function. The results showed clear reduction of spasticity in the flexor muscles, as well as improvement of motor function in the upper extremity.

Implications: The therapeutic approach we propose here should be broadly used after verification in a prospective randomized control study.

Keywords: Stroke, kinesthetic illusion induced by visual stimulation, brain-machine interface (BMI)

Funding acknowledgements: This work was supported by the Development of Medical Devices and Systems for Advanced Medical Services by AMED.

Topic: Neurology: stroke; Human movement analysis; Robotics & technology

Ethics approval required: Yes
Institution: Shonan Keiiku Hospital
Ethics committee: The Institutional Research Ethics Cmmittee of the Shonan Keiiku Hospital
Ethics number: 17-0001


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