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A Study of Meltin Robot Hand Rehabilitation after Botulinum Therapy in Post-stroke Spasticity (MeltinRobot/BTX)

A study of using a robot controlling finger movement and botulinum therapy in patients who suffered from stroke (MeltinRobot/BTX Study)

4

Mechanical 1) 3 (2 male, 1 female) Mechanical 2) 1 (1 male) Patients had been treated with BoNT injections for more than 12 months (or 3-4 sessions of 200-300 units of onabotulinumtoxinA). Total of 15 patients were analyzed ,were accepted the purpose of the study and be able to visit regularly for robotic treatment and BoNT injections for the study period.

The study aimed to conduct a proof-of-concept (POF) trial to maximize the safety of the robot and its add-on effect to botulinum therapy. Machine 1) (glove-wearing type), flexion and extension of the fingers could not be performed due to the size of the patient's hands and misalignment during movement assistance. Machine 2) (outrigger type), fixation device was used to hold the fingers in place and improved misalignment during motion compensation, but it was difficult to fully flex the fingers for a patient with strong spasticity.

No adverse event

Machine 1) did not lead to any results, as only 3 patients were eligible for machine 1 and only 1 patient was eligible for machine 2).

The study aimed to conduct a proof-of-concept (POF) trial to maximize the safety of the robot and its add-on effect to botulinum therapy. 4 patients used the robot, but the results were not encouraging. In addition,due to the impact of Covid19, the number of patient visits and rehabilitation time could not be sufficiently secured, and the study was terminated midway.

Jan. 10, 2023

No

No

https://jrct.mhlw.go.jp/latest-detail/jRCTs062190016

Fujita Koji

Tokushima University

Kuramotocho 3-18-15

kfujita@tokushima-u.ac.jp

Kaji Ryuji

National Hospital Organization Utano Hospital

Narutakiondoyamacho 8, Ukyoku, Kyoto

+81-75-461-5121

kajkyoto@mbox.kyoto-inet.or.jp

Complete

Aug. 01, 2019

Interventional

single arm study

open(masking not used)

no treatment control/standard of care control

crossover assignment

treatment purpose

aged 20-90
more than 1 year after the onset of stroke
without any recurrence of stroke
cognitive function not decreased (HDSR>23)
No signs of depression
No other active diseases affecting other organs or mental disorders

Pregnancy
Serious systemic diseses
Progressive CNS disorders (e.g brain tumors)
contractures or severe spasticity of finger joint (MAS=4)

Both

Upper limb spasticity after stroke

Botulinum therapy is performed in patients with post-stroke upper limb spasticty including finger joints. Immediately after the therapy robot rehabilitation is done for those treated joints. The same rehabilitation is performed at 1 months after the botulinum therapy, when its effect reaches the maximum. The results are evaluated as measuring the active range of motion of the finger joints, and are compared betwen those immediately after and 1month after the botulinum therapy, so that the additive effect of the botulinum therapy and the robot rehabilitation is explored.

post-stroke, spasticity, upper limb, finger joints

robot, rehabilitation, botulinum therapy

spasticity

rehabiliation

1. Modified Ashworth Scale (MAS) of the finger joints

2. Active ROM (range of motion) of the finger joints

1. Fugel-Myer Assessment of the finger joints
2.Brunnstrom stage of the finger joints
3. Visual Analogue Scale by the patient
4. Sensory function (position, kinesithesia)
5. Any technical problems of the robot

+81-88-633-7958

Aug. 13, 2019

none