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Mar. 29, 2019 |
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Feb. 20, 2026 |
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jRCTs042180178 |
Research of upper limb rehabilitation training robot |
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Upper limb rehabilitation training robot |
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May. 23, 2024 |
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44 |
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Subject information (Stroke patients: Thirty-nine) Average age (year): 58.7 (36-75), Sex (male/female): 28/11, Affected side (right/left): 21/18, Average time from onset to intervention (days): 60.3 (22-130), Diagnosis (cerebral hemorrhage/cerebral infarction): 27/12 Average FIM motor item: 68.5, Average FIM cognitive item: 29.2 Subject information (Healthy subjects: Five) Average age (year): 30.6 (24-43), Sex (male/female): 4/1 |
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Cumulative number of cases 2019: 5, 2020: 12, 2021: 18, 2022: 26, 2023: 42, 2024: 44 (healthy people: Five, stroke patients: Thirty-nine) *Beginning in April 2024, the upper limb robot began experiencing sporadic malfunctions (the robot would stop working). A contractor carried out maintenance in July, but the problem was not resolved, and recruitment of participants was discontinued. This study has been terminated due to the possibility of serious risks. *The cumulative number of cases reported in the previous periodic was 39 (Number of completed cases: 38, Number of discontinued cases: 1), but the correct number was 42 (Number of completed cases: 41, Number of discontinued cases: 1). |
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One subject in the control group experienced a recurrent stroke during the study period, but this was not causally related to the study design. |
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Gain results were shown in the order of upper limb robot group A (2sets/day), upper limb robot group B (1set/day), and the control group. Second outcomes show only items that could be assessed in all patients. Main outcome (Fugl-Meyer Assessment upper limbs total score): 9.0/5.8/5.5 Second outcomes: Shoulder joint flexion range of motion: 16.4/19.6/14.6, Elbow joint extension range of motion: 10.5/3.8/6.2, Functional Skills Measure After Paralysis: 6.9/7.6/6.7, Motor Activity Log (AOU): 0.7/1.0/0.8, (QOM): 0.6/1.2/0.8, Action Research Arm Test: 7.3/5.9/5.9, Data held within the robot: Smoothness: 0.076/0.074/0.034 (p<0.05*), Reach Error: -3.1/-3.3/-1.9, Mean Path Error: -0.772/0.007/-0.466 (p<0.05**), Independence: 0.191/0.185/0.074 * There was a significant difference between the upper limb robot group B and the control group. ** There was a significant difference between the upper limb robot group A and the control group. |
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In the secondary evaluation, the upper limb robot group B showed significant improvement compared to the control group in "Smoothness", and the "mean path error" showed a significant improvement in the upper limb robot group A compared to the control group. These results suggest that increasing the amount of training using the InMotion ARM Robot was effective in improving the smoothness and accuracy of reaching movements. |
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Feb. 20, 2026 |
No |
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none |
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https://jrct.mhlw.go.jp/latest-detail/jRCTs042180178 |
Otaka Yohei |
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Fujita Health University NanakuriMemorial Hospital |
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424-1, Oodori, Tsu, Mie |
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+81-59-252-1555 |
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yootaka@fujita-hu.ac.jp |
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Miyasaka Hiroyuki |
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Fujita Health University NanakuriMemorial Hospital |
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424-1, Oodori, Tsu, Mie |
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+81-59-252-1555 |
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hmiyasak@fujita-hu.ac.jp |
Complete |
Aug. 01, 2015 |
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| Aug. 18, 2015 | ||
| 100 | ||
Interventional |
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randomized controlled trial |
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single blind |
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historical control |
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parallel assignment |
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treatment purpose |
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1. First stroke in the cerebral hemisphere patients |
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1. Severe aphasia |
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| 20age old over | ||
| 80age old under | ||
Both |
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stroke patients |
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rehabilitation |
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Stroke Impairment Assessment Set, Fugl-Meyer Assessment |
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Active range of motion of the shoulder and elbow joint, Modified Ashworth Scale, 3-dimensional motion analysis, Simple Test for Evaluating Hand Function, Functional Skills Measure After Paralysis, Wolf Motor Function Test, Motor Activity Log, Functional Independence Measure, Action Research Arm Test, Electrophysiologic test, Data in robot equipment |
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| Fujita Health University Certified Review Board | |
| 1-98, Dengakugakubo, Kutukakecho, Toyoake, Aichi | |
+81-562-93-2865 |
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| crb-f@fujita-hu.ac.jp | |
| Approval | |
Feb. 14, 2019 |
none |