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利用者名
UMIN ID

試験進捗状況 限定募集中/Enrolling by invitation
UMIN試験ID UMIN000044590
受付番号 R000050906
科学的試験名
一般公開日(本登録希望日) 2022/05/15
最終更新日 2021/06/18

※ 本ページ収載の情報は、臨床試験に関する情報公開を目的として、UMINが開設しているUMIN臨床試験登録システムに提供された臨床試験情報です。
※ 特定の医薬品や治療法等については、医療関係者や一般の方に向けて広告することは目的としていません。


基本情報/Basic information
一般向け試験名/Public title
Efficacy and evaluation of the application of mixed reality
rehabilitation training coupled with artificial intelligence
analysis software for upper limb rehabilitation in stroke patients
一般向け試験名略称/Acronym
Efficacy and evaluation of the application of mixed reality
rehabilitation training coupled with artificial intelligence
analysis software for upper limb rehabilitation in stroke patients
科学的試験名/Scientific Title
Efficacy and evaluation of the application of mixed reality
rehabilitation training coupled with artificial intelligence
analysis software for upper limb rehabilitation in stroke patients
科学的試験名略称/Scientific Title:Acronym
Efficacy and evaluation of the application of mixed reality
rehabilitation training coupled with artificial intelligence
analysis software for upper limb rehabilitation in stroke patients
試験実施地域/Region
アジア(日本以外)/Asia(except Japan)

対象疾患/Condition
対象疾患名/Condition
Experiment on rehabilitation targeting stroke patients using mixed reality rehabilitation
疾患区分1/Classification by specialty
神経内科学/Neurology リハビリテーション医学/Rehabilitation medicine
成人/Adult
疾患区分2/Classification by malignancy 悪性腫瘍以外/Others
ゲノム情報の取扱い/Genomic information いいえ/NO

目的/Objectives
目的1/Narrative objectives1
combine mixed reality rehabilitation to deliver a standardized intervention,
subject will follow the virtual coach with same movement, and every action will be recorded and scored by software. Our primary goal
is to evaluate training dose and intensity in stroke patient by using
Fugl-Meyer Assessment-lower extremity (FMA-LE), Maximum walking speed
(MWS), Berg Balance Scale (BBS), Stroke Impact Scale (SIS), Modified
Rankin Scale (MRS), Barthel Index (BI). Secondary, we measured safety
and acceptance by record the adverse effect with occurrence frequency,
and satisfaction rated by subjects.
目的2/Basic objectives2 その他/Others
目的2 -その他詳細/Basic objectives -Others
Additionally, we analysis the serum level of oxidative stress by
superoxide and 8-OHdG; inflammation cytokine IL-6, TNF-alpha;
neuroplasticity biomarker BDNF, and the putative signal transduction pathway will be discussed further
試験の性質1/Trial characteristics_1 検証的/Confirmatory
試験の性質2/Trial characteristics_2 説明的/Explanatory
試験のフェーズ/Developmental phase 第Ⅰ相/Phase I

評価/Assessment
主要アウトカム評価項目/Primary outcomes
Results shown that upper limb function (FMA-UE), biomarkers correlated to oxidative stress (HO-1 and 8-OHdG), and BDNF have significant improvement after mixed reality rehabilitation trainings.
副次アウトカム評価項目/Key secondary outcomes
Although the change of serum molecular in mixed reality rehabilitation group did not reached significance compared to the control group. It is also suggests that the motor recovery was associated with the increase of HO-1 and decrease of 8-OHdG.

基本事項/Base
試験の種類/Study type 介入/Interventional

試験デザイン/Study design
基本デザイン/Basic design クロスオーバー試験/Cross-over
ランダム化/Randomization ランダム化/Randomized
ランダム化の単位/Randomization unit 個別/Individual
ブラインド化/Blinding 試験参加者がブラインド化されている単盲検/Single blind -participants are blinded
コントロール/Control 無治療対照/No treatment
層別化/Stratification いいえ/NO
動的割付/Dynamic allocation いいえ/NO
試験実施施設の考慮/Institution consideration 動的割付けの際に施設を調整因子としている/Institution is considered as adjustment factor in dynamic allocation.
ブロック化/Blocking いいえ/NO
割付コードを知る方法/Concealment 封筒法/Numbered container method

介入/Intervention
群数/No. of arms 2
介入の目的/Purpose of intervention 治療・ケア/Treatment
介入の種類/Type of intervention
手技/Maneuver
介入1/Interventions/Control_1
rehabilitation without mixed reality rehabilitation
介入2/Interventions/Control_2
Healthy individuals who does not require rehabilitation will be going through the same length of process as others
介入3/Interventions/Control_3

介入4/Interventions/Control_4

介入5/Interventions/Control_5

介入6/Interventions/Control_6

介入7/Interventions/Control_7

介入8/Interventions/Control_8

介入9/Interventions/Control_9

介入10/Interventions/Control_10


適格性/Eligibility
年齢(下限)/Age-lower limit
20 歳/years-old 以上/<=
年齢(上限)/Age-upper limit
75 歳/years-old 以下/>=
性別/Gender 男女両方/Male and Female
選択基準/Key inclusion criteria
patient age between 20 to 75 years, first onset of stroke over 3 months. Brunnstrom stage higher than 3, having a diagnosis with stroke and confirmed with Computed tomography or Magnetic Resonance Imaging scans, being able to understand instructions, Mini-Mental State Examination score higher than 18 and, no other neurological disorders as comorbid.
除外基準/Key exclusion criteria
participated in other rehabilitation related or clinical trials within 3 months of the experiment, having sensory apraxia, having severe impairments in vision or visual perception such as hemi-neglect, receiving warfarin or VitK antagonist treatment, having high risk of epilepsy, failure to cooperate with the researcher to execute mixed reality rehabilitation activities and refusing to take the blood test.
目標参加者数/Target sample size 30

責任研究者/Research contact person
責任研究者/Name of lead principal investigator

ミドルネーム

Ping-Chia
ミドルネーム
Li
所属組織/Organization
I-Shou Univeristy
所属部署/Division name
Department of Occupational Therapy
郵便番号/Zip code 82445
住所/Address
No. 8, Yida Rd., Tanchao Township, Kaohsiung, Taiwan
電話/TEL 886761511007513
Email/Email pingchiali@gmail.com

試験問い合わせ窓口/Public contact
試験問い合わせ窓口担当者/Name of contact person

ミドルネーム

Ping-Chia
ミドルネーム
Li
組織名/Organization
I-Shou Univeristy
部署名/Division name
Department of Occupational Therapy
郵便番号/Zip code 82445
住所/Address
No. 8, Yida Rd., Tanchao Township, Kaohsiung, Taiwan
電話/TEL 886761511007513
試験のホームページURL/Homepage URL
Email/Email pingchiali@gmail.com

実施責任組織/Sponsor
機関名/Institute その他 Ministry of science and technology, Republic of China
MOST 105-2321-B-214-001
機関名/Institute
(機関選択不可の場合)

部署名/Department

研究費提供組織/Funding Source
機関名/Organization その他 Ministry of science and technology, Republic of China
MOST 105-2321-B-214-001
機関名/Organization
(機関選択不可の場合)

組織名/Division
組織の区分/Category of Funding Organization 地方自治体/Local Government
研究費拠出国/Nationality of Funding Organization
Republic of China, Taiwan

その他の関連組織/Other related organizations
共同実施組織/Co-sponsor

その他の研究費提供組織/Name of secondary funder(s)


IRB等連絡先(公開)/IRB Contact (For public release)
組織名/Organization
Institutional review board of E-Da hospital
住所/Address
No. 6 Yida road, jiaosu village, yanchao district, kaohsiung city, 82445, Republic of China, Taiwan
電話/Tel 886761511005111
Email/Email ed103800@edah.org.tw

他機関から発行された試験ID/Secondary IDs
他機関から発行された試験ID/Secondary IDs いいえ/NO
試験ID1/Study ID_1
ID発行機関1/Org. issuing International ID_1

試験ID2/Study ID_2
ID発行機関2/Org. issuing International ID_2

治験届/IND to MHLW

試験実施施設/Institutions
試験実施施設名称/Institutions

その他の管理情報/Other administrative information
一般公開日(本登録希望日)/Date of disclosure of the study information
2022 05 15

関連情報/Related information
プロトコル掲載URL/URL releasing protocol
試験結果の公開状況/Publication of results 未公表/Unpublished

結果/Result
結果掲載URL/URL related to results and publications
組み入れ参加者数/Number of participants that the trial has enrolled
主な結果/Results

主な結果入力日/Results date posted
結果掲載遅延/Results Delayed
結果遅延理由/Results Delay Reason

最初の試験結果の出版日/Date of the first journal publication of results
参加者背景/Baseline Characteristics

参加者の流れ/Participant flow

有害事象/Adverse events

評価項目/Outcome measures

個別症例データ共有計画/Plan to share IPD

個別症例データ共有計画の詳細/IPD sharing Plan description


試験進捗状況/Progress
試験進捗状況/Recruitment status 限定募集中/Enrolling by invitation
プロトコル確定日/Date of protocol fixation
2021 08 01
倫理委員会による承認日/Date of IRB
2021 05 16
登録・組入れ開始(予定)日/Anticipated trial start date
2021 12 01
フォロー終了(予定)日/Last follow-up date
2023 05 15
入力終了(予定)日/Date of closure to data entry
データ固定(予定)日/Date trial data considered complete
解析終了(予定)日/Date analysis concluded

その他/Other
その他関連情報/Other related information


管理情報/Management information
登録日時/Registered date
2021 06 18
最終更新日/Last modified on
2021 06 18


閲覧ページへのリンク/Link to view the page
URL(日本語) https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000050906
URL(英語) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050906

研究計画書
登録日時 ファイル名

研究症例データ仕様書
登録日時 ファイル名

研究症例データ
登録日時 ファイル名


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