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)
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.
/
本研究への参加により有害事象を発生した対象者はいなかった。
No subject experienced an adverse event as a result of participation in this study.
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.
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.
2023年06月01日
3 IPDシェアリング
/
無
No
/
該当なし
N/A
管理的事項
研究の種別
特定臨床研究
届出日
令和5年5月12日
臨床研究実施計画番号
jRCTs042200016
1 特定臨床研究の実施体制に関する事項及び特定臨床研究を行う施設の構造設備に関する事項
(1)研究の名称
健常者および中枢性麻痺患者に対する上肢痙縮測定装置の臨床応用に関する研究
Study on clinical application of upper limb spasticity measuring device to healthy and central paralysis (ULSMD)
上肢痙縮測定装置の臨床応用
Clinical application of measuring device for upper limb spasticity (MDULS)