| Project/Area Number |
19K19788
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| Research Category |
Grant-in-Aid for Early-Career Scientists
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| Allocation Type | Multi-year Fund |
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| Review Section |
Basic Section 59010:Rehabilitation science-related
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| Research Institution | University of Tsukuba |
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Principal Investigator |
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| Project Period (FY) |
2019-04-01 – 2023-03-31
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| Project Status |
Completed (Fiscal Year 2022)
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| Budget Amount *help |
¥4,160,000 (Direct Cost: ¥3,200,000、Indirect Cost: ¥960,000)
Fiscal Year 2021: ¥910,000 (Direct Cost: ¥700,000、Indirect Cost: ¥210,000)
Fiscal Year 2020: ¥650,000 (Direct Cost: ¥500,000、Indirect Cost: ¥150,000)
Fiscal Year 2019: ¥2,600,000 (Direct Cost: ¥2,000,000、Indirect Cost: ¥600,000)
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| Keywords | 急性期脳卒中片麻痺 / 装着型サイボーグHAL / ロボットスーツHAL / 歩行自立度 / 歩行改善治療 / 理学療法 / リハビリテーション / 脳卒中 / 歩行自立度（FAC） / ランダム化比較試験 / 特定臨床研究 / 平地歩行練習 / 急性期脳卒中 / 重度片麻痺 |
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| Outline of Research at the Start |
本研究では，急性期重度片麻痺患者におけるHAL歩行治療の有用性を従来治療群（長下肢装具を使用した歩行練習）との比較により検討する．
本研究の遂行により急性期重度片麻痺患者の歩行障害に対する革新的な歩行改善治療法の確立に寄与し，臨床応用が期待できる．
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| Outline of Final Research Achievements |
A new specific clinical trial was planned to establish an innovative gait therapy using HAL for patients with acute severe hemiplegia and was initiated in October 2020; as of April 2023, 16 cases (intervention group: 10 cases, control group: 6 cases) had been completed and 7 cases had been evaluated after 6 months. There were no severe illnesses or adverse events. Both groups showed improvement in lower limb motor paralysis, walking ability, and ADL ability. The mean change in independent walking (FAC) from start to end was 1.2 in the intervention group and 0.5 in the control group, with a particular improvement in independent walking in the intervention group, and the amount of walking practice was secured. There were no falls or abrasions during the gait intervention and it can be performed safely. The study is continuing to enroll more cases.
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| Academic Significance and Societal Importance of the Research Achievements |
本研究の実施により急性期重度片麻痺患者に対するHALを用いた革新的歩行治療の確立に貢献できる可能性がある。特に急性期脳卒中片麻痺患者を対象にHALの効果を比較検討している研究は世界的にも少ない。ロボット技術のリハビリテーション分野への導入は開始され始めたものの、有効性や適応患者についてはまだまだ課題が多い。HALの適応となりやすい患者層はどこなのか、従来の平地歩行練習との相違点（効果の違い）を検討することで、HALの適応患者の選択等に寄与できると考える。革新的技術の導入により、従来治療を超えた歩行自立度の改善、ADL能力の向上が期待できる。
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