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June. 03, 2020 |
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June. 01, 2023 |
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jRCTs042200016 |
Study on clinical application of upper limb spasticity measuring device to healthy and central paralysis (ULSMD) |
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Clinical application of measuring device for upper limb spasticity (MDULS) |
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April. 01, 2023 |
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15 |
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4 healthy subjects (male/female ratio 3:1, mean age 28 years), 11 patients with central nervous system disease (male/female ratio 9:2, mean age 70 years) |
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Fifteen subjects were included in the study after the study content was fully explained and written consent was obtained. An upper limb spasticity measuring device was attached to the elbow joint of the subjects, and the joint resistance torque values were measured when the elbow joint was extended in an altruistic manner. |
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No subject experienced an adverse event as a result of participation in this study. |
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The primary assessment was the value of joint resistance torque during other dynamic elbow extension exercises. Secondary endpoints included range of motion of the elbow joint, muscle tone during manual movement using the Modified Ashworth Scale, deep tendon reflexes in the upper limb, and upper limb motor function compared to the torque value of joint resistance during elbow extension. The higher the joint resistance torque value during elbow extension at a speed of 300 degree per sec, the more abnormal muscle tone was observed. On the other hand, the torque values did not discriminate between normal subjects and those with mild spasticity. It was also weakly correlated with the Modified Ashworth Scale. On the other hand, there was no clear trend with deep tendon reflexes or upper limb motor function. |
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To quantitatively evaluate abnormal muscle hypertonia (spasticity), we measured the joint resistance torque values generated during elbow extension in healthy subjects and patients with central nervous system disease using an instrument we developed. The results showed that the more severe the spasticity, the higher the joint resistance torque value, but it was difficult to measure the difference between normal subjects and patients with mild spasticity. |
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June. 01, 2023 |
No |
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N/A |
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https://jrct.mhlw.go.jp/latest-detail/jRCTs042200016 |
Otaka Yohei |
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Fujita Health University Hospital |
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1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi |
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+81-562-93-2167 |
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rehabmed@fujita-hu.ac.jp |
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Mukaino Masahiko |
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Fujita Health University Hospital |
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1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi |
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+81-562-93-2167 |
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mmukaino@fujita-hu.ac.jp |
Complete |
June. 03, 2020 |
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| 90 | ||
Interventional |
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single arm study |
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open(masking not used) |
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uncontrolled control |
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single assignment |
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diagnostic purpose |
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upper motor neuron disorder |
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Unstable condition patients |
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| No limit | ||
| No limit | ||
Both |
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Cerebral vascular disease, Spinal cord injury |
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We measure spasticity using the developed device in healthy subjects and central paralysis patients. |
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elbow joint resistance torque |
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range of joint movement, muscle tone when manually moved by Modified Ashworth Scale, deep tendon reflex, upper limb motor function |
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| Fujita Health University Certified Clinical Research Review Board | |
| 1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi | |
+81-562-93-2865 |
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| f-irb@fujita-hu.ac.jp | |
| Approval | |
May. 01, 2020 |
none |