UMIN-CTR 臨床試験登録情報の閲覧

UMIN試験ID	UMIN000056619
受付番号	R000064711
科学的試験名	脳卒中後の重度片麻痺および半側空間無視を伴うPusher症例おける長下肢装具を用いた歩行訓練が歩行能力と自立に及ぼす影響：後方視的対照研究
一般公開日（本登録希望日）	2025/01/06
最終更新日	2025/01/03 14:40:47

※ 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

日本語
脳卒中後の重度片麻痺および半側空間無視を伴うPusher症例おける長下肢装具を用いた歩行訓練が歩行能力と自立に及ぼす影響：後方視的対照研究

英語
Influences of gait training with knee-ankle-foot orthosis on gait ability and independence in severe hemiplegia and pusher behavior with unilateral spatial neglect following stroke: A retrospective historical controlled study

一般向け試験名略称/Acronym

科学的試験名/Scientific Title

科学的試験名略称/Scientific Title:Acronym

試験実施地域/Region

日本/Japan

対象疾患/Condition

対象疾患名/Condition

日本語
脳卒中症例

英語
In patients after stroke

疾患区分1/Classification by specialty

リハビリテーション医学/Rehabilitation medicine

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

日本語
本研究は、KAFOを用いた歩行訓練が、USN後の重度脳卒中片麻痺およびプッシャー行動患者の歩行能力および自立に及ぼす影響を検討することを目的とした。

英語
This study aimed to influence of gait training using KAFOs on gait ability and independent in patients with severe stroke hemiplegia and pusher behavior following USN.

目的2/Basic objectives2

安全性・有効性/Safety,Efficacy

目的2 -その他詳細/Basic objectives -Others

日本語

英語

試験の性質1/Trial characteristics_1

試験の性質2/Trial characteristics_2

試験のフェーズ/Developmental phase

評価/Assessment

主要アウトカム評価項目/Primary outcomes

日本語
Scale for Contraversive Pushing (SCP), BITc (BIT-conventional test), Subjective Postural Vertical (SPV), SPV with eyes opened (SPV-EO) direction errors, variability errors, functional ambulation category; FAC and gait independence (FIM-gait).

英語
Scale for Contraversive Pushing (SCP), BITc (BIT-conventional test), Subjective Postural Vertical (SPV), SPV with eyes opened (SPV-EO) direction errors, variability errors, functional ambulation category; FAC and gait independence (FIM-gait).

副次アウトカム評価項目/Key secondary outcomes

日本語

英語

基本事項/Base

試験の種類/Study type

観察/Observational

試験デザイン/Study design

基本デザイン/Basic design

ランダム化/Randomization

ランダム化の単位/Randomization unit

ブラインド化/Blinding

コントロール/Control

層別化/Stratification

動的割付/Dynamic allocation

試験実施施設の考慮/Institution consideration

ブロック化/Blocking

割付コードを知る方法/Concealment

介入/Intervention

群数/No. of arms

介入の目的/Purpose of intervention

英語

適格性/Eligibility

年齢（下限）/Age-lower limit

18 歳/years-old 以上/<=

年齢（上限）/Age-upper limit

90 歳/years-old 未満/>

性別/Gender

男女両方/Male and Female

選択基準/Key inclusion criteria

日本語
The inclusion criteria comprised first-ever stroke cases, Brunnstrom Recovery Stage-Lower Limb (BRS-L) under III, indicating severe hemiplegia.

英語
The inclusion criteria comprised first-ever stroke cases, Brunnstrom Recovery Stage-Lower Limb (BRS-L) under III, indicating severe hemiplegia.

除外基準/Key exclusion criteria

日本語
Exclusion criteria included BRS over IV, dementia, multiple cerebral infarctions, hydrocephalus, and poor understanding.

英語
Exclusion criteria included BRS over IV, dementia, multiple cerebral infarctions, hydrocephalus, and poor understanding.

目標参加者数/Target sample size

責任研究者/Research contact person

責任研究者/Name of lead principal investigator

日本語

名広太

ミドルネーム

姓澤

英語

名 Kota

ミドルネーム

姓 Sawa

所属組織/Organization

日本語
SBC Tokyo Medical University

英語
SBC Tokyo Medical University

所属部署/Division name

日本語
健康科学部理学療法学科

英語
Department of Physical Therapy, Faculty of Health Sciences

郵便番号/Zip code

2798567

住所/Address

日本語
千葉県浦安市明海５－８－１

英語
5-8-1 Akemi, Urayasu, Chiba, Japan

電話/TEL

08012079205

Email/Email

k-sawa@sbctmu.ac.jp

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

日本語

名 Kota

ミドルネーム

姓 Sawa

英語

名 Kota

ミドルネーム

姓 Sawa

組織名/Organization

日本語
SBC Tokyo Medical University

英語
SBC Tokyo Medical University

部署名/Division name

日本語
Department of Physical Therapy, Faculty of Health Sciences

英語
Department of Physical Therapy, Faculty of Health Sciences

郵便番号/Zip code

2798567

住所/Address

日本語
5-8-1 Akemi, Urayasu, Chiba, Japan

英語
5-8-1 Akemi, Urayasu, Chiba, Japan

電話/TEL

08012079205

試験のホームページURL/Homepage URL

Email/Email

k-sawa@sbctmu.ac.jp

実施責任個人または組織/Sponsor or person

機関名/Institute

日本語
その他

英語
SBC Tokyo Medical University

機関名/Institute
（機関選択不可の場合）

日本語
SBC Tokyo Medical University

部署名/Department

日本語
Department of Physical Therapy, Faculty of Health Sciences

個人名/Personal name

日本語
澤広太

英語
Kota Sawa

研究費提供組織/Funding Source

機関名/Organization

日本語
その他

英語
SBC Tokyo Medical University

機関名/Organization
（機関選択不可の場合）

日本語
SBC Tokyo Medical University

組織名/Division

日本語
Department of Physical Therapy, Faculty of Health Sciences

組織の区分/Category of Funding Organization

自己調達/Self funding

研究費拠出国/Nationality of Funding Organization

日本語

英語

その他の関連組織/Other related organizations

共同実施組織/Co-sponsor

日本語

英語

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

日本語

英語

IRB等連絡先（公開）/IRB Contact (For public release)

組織名/Organization

日本語
SBC Tokyo Medical University

英語
SBC Tokyo Medical University

住所/Address

日本語
千葉県浦安市明海５－８－１

英語
5-8-1, Akemi, Urayasu, Chiba, Japan, 279-8567

電話/Tel

08012079205

Email/Email

k-sawa@sbctmu.ac.jp

他機関から発行された試験ID/Secondary IDs

はい/YES

試験ID1/Study ID_1

No. 000049806

ID発行機関1/Org. issuing International ID_1

日本語
The University Hospital Medical Information Network Center

英語
The University Hospital Medical Information Network Center

試験ID2/Study ID_2

ID発行機関2/Org. issuing International ID_2

日本語

英語

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

2025 年 01 月 06 日

結果/Result

結果掲載URL/URL related to results and publications

https://doi.org/10.1002/brb3.3001

組み入れ参加者数/Number of participants that the trial has enrolled

主な結果/Results

日本語
A significant interaction was noted between gait independence and FAC, as well as a simple primary effect of timing and group; the pusher group exhibited a lower degree of improvement at discharge (p<0.05). Multiple regression analysis was used to predict the long-term prognosis of gait independence in patients with severe hemiplegia, KAFOs, and pusher behavior.

英語
A significant interaction was noted between gait independence and FAC, as well as a simple primary effect of timing and group; the pusher group exhibited a lower degree of improvement at discharge (p<0.05). Multiple regression analysis was used to predict the long-term prognosis of gait independence in patients with severe hemiplegia, KAFOs, and pusher behavior.

主な結果入力日/Results date posted

2025 年 01 月 03 日

結果掲載遅延/Results Delayed

結果遅延理由/Results Delay Reason

日本語

英語

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

日本語
The participant pool included 44 patients, comprising 22 hemiplegics and 22 patients with pusher behavior. Demographic data were matched using a propensity score (PS) to adjust for heterogeneity in background factors (baseline covariates) at a new study-patient ratio of 1:1.

英語
The participant pool included 44 patients, comprising 22 hemiplegics and 22 patients with pusher behavior. Demographic data were matched using a propensity score (PS) to adjust for heterogeneity in background factors (baseline covariates) at a new study-patient ratio of 1:1.

参加者の流れ/Participant flow

日本語
Procedure A
A significant interaction was noted between gait independence and FAC, as well as a simple primary effect of timing and group; the pusher group exhibited a lower degree of improvement at discharge (p<0.05, Table 2, Figure 3).
Procedure B
Multiple regression analysis was used to predict the long-term prognosis of gait independence in patients with severe hemiplegia, KAFOs, and pusher behavior. The study items included age, sex, onset days, BRS-L, MMSE, damaged hemispheric side, SIAS, SCP, BITc, SPV, SPV-EO directional errors, and variability errors. Onset days and SPV variability errors were identified as influencing factors in severe hemiplegia cases, and SPV-EO variability errors in pusher cases, each with moderate regression coefficients (p<0.05) (Table 3).

英語
Procedure A
A significant interaction was noted between gait independence and FAC, as well as a simple primary effect of timing and group; the pusher group exhibited a lower degree of improvement at discharge (p<0.05, Table 2, Figure 3).
Procedure B
Multiple regression analysis was used to predict the long-term prognosis of gait independence in patients with severe hemiplegia, KAFOs, and pusher behavior. The study items included age, sex, onset days, BRS-L, MMSE, damaged hemispheric side, SIAS, SCP, BITc, SPV, SPV-EO directional errors, and variability errors. Onset days and SPV variability errors were identified as influencing factors in severe hemiplegia cases, and SPV-EO variability errors in pusher cases, each with moderate regression coefficients (p<0.05) (Table 3).

有害事象/Adverse events

日本語
None.

英語
None.

評価項目/Outcome measures

日本語
For outcomes in procedure A: two-way analysis of variance was utilized to confirm interactions and simple main effects, using the Bonferroni method as a post-hoc test (p<0.05). For outcomes in procedure B: multiple regression analysis (stepwise method) was applied to examine gait independence within the two groups.28 Factor analysis variables were analyzed using group gait ability (FAC and FIM) as the dependent variable and characteristic factors as the independent variables (p<0.05).

英語
For outcomes in procedure A: two-way analysis of variance was utilized to confirm interactions and simple main effects, using the Bonferroni method as a post-hoc test (p<0.05). For outcomes in procedure B: multiple regression analysis (stepwise method) was applied to examine gait independence within the two groups.28 Factor analysis variables were analyzed using group gait ability (FAC and FIM) as the dependent variable and characteristic factors as the independent variables (p<0.05).

個別症例データ共有計画/Plan to share IPD

日本語

英語

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

日本語

英語

試験進捗状況/Progress

試験進捗状況/Recruitment status

試験終了/Completed

プロトコル確定日/Date of protocol fixation

2017 年 04 月 01 日

倫理委員会による承認日/Date of IRB

2021 年 11 月 18 日

登録・組入れ開始（予定）日/Anticipated trial start date

2017 年 04 月 01 日

フォロー終了(予定)日/Last follow-up date

2022 年 03 月 31 日

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

日本語
Procedure A: The long-term prognosis was evaluated in two groups of patients: those with severe motor paralysis and those with severe motor paralysis along with pusher behavior.
Procedure B: Factors influencing gait ability in pusher cases were investigated. The timing of KAFOs use in both groups was defined as within 1 week of the rehabilitation prescription date in sub-acute-phase hospital. Furthermore, considering the severity of motor paralysis, patients utilized KAFOs for over 3 months during rehabilitation and ADLs.
Regarding the utilization of KAFOs in the course of routine rehabilitation, patients received physical therapy, occupational therapy, and speech therapy for 3 h, 7 days a week, over consecutive weeks. During specific interventions, KAFOs were employed for 1 h during standing and gait exercises (Figure 2). In ADLs scenarios, transfers and toileting were permitted with AFOs. Patients were allowed to use AFOs for transferring and toileting in ADLs situations and to continue gait rehabilitation using KAFOs or AFOs throughout the intervention period.

英語
Procedure A: The long-term prognosis was evaluated in two groups of patients: those with severe motor paralysis and those with severe motor paralysis along with pusher behavior.
Procedure B: Factors influencing gait ability in pusher cases were investigated. The timing of KAFOs use in both groups was defined as within 1 week of the rehabilitation prescription date in sub-acute-phase hospital. Furthermore, considering the severity of motor paralysis, patients utilized KAFOs for over 3 months during rehabilitation and ADLs.
Regarding the utilization of KAFOs in the course of routine rehabilitation, patients received physical therapy, occupational therapy, and speech therapy for 3 h, 7 days a week, over consecutive weeks. During specific interventions, KAFOs were employed for 1 h during standing and gait exercises (Figure 2). In ADLs scenarios, transfers and toileting were permitted with AFOs. Patients were allowed to use AFOs for transferring and toileting in ADLs situations and to continue gait rehabilitation using KAFOs or AFOs throughout the intervention period.

管理情報/Management information

登録日時/Registered date

2025 年 01 月 03 日

最終更新日/Last modified on

2025 年 01 月 03 日

閲覧ページへのリンク/Link to view the page

日本語
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000064711

英語
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064711

UMIN-CTR 臨床試験登録情報の閲覧

基本情報/Basic information

一般向け試験名/Public title

一般向け試験名略称/Acronym

科学的試験名/Scientific Title

科学的試験名略称/Scientific Title:Acronym

試験実施地域/Region

対象疾患/Condition

対象疾患名/Condition

疾患区分1/Classification by specialty

疾患区分2/Classification by malignancy

ゲノム情報の取扱い/Genomic information

目的/Objectives

目的1/Narrative objectives1

目的2/Basic objectives2

目的2 -その他詳細/Basic objectives -Others

試験の性質1/Trial characteristics_1

試験の性質2/Trial characteristics_2

試験のフェーズ/Developmental phase

評価/Assessment

主要アウトカム評価項目/Primary outcomes

副次アウトカム評価項目/Key secondary outcomes

基本事項/Base

試験の種類/Study type

試験デザイン/Study design

基本デザイン/Basic design

ランダム化/Randomization

ランダム化の単位/Randomization unit

ブラインド化/Blinding

コントロール/Control

層別化/Stratification

動的割付/Dynamic allocation

試験実施施設の考慮/Institution consideration

ブロック化/Blocking

割付コードを知る方法/Concealment

介入/Intervention

群数/No. of arms

介入の目的/Purpose of intervention

介入の種類/Type of intervention

介入1/Interventions/Control_1

介入2/Interventions/Control_2

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

年齢（上限）/Age-upper limit

性別/Gender

選択基準/Key inclusion criteria

除外基準/Key exclusion criteria

目標参加者数/Target sample size

責任研究者/Research contact person

責任研究者/Name of lead principal investigator

所属組織/Organization

所属部署/Division name

郵便番号/Zip code

住所/Address

電話/TEL

Email/Email

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

組織名/Organization

部署名/Division name

郵便番号/Zip code

住所/Address

電話/TEL

試験のホームページURL/Homepage URL

Email/Email

実施責任個人または組織/Sponsor or person

機関名/Institute

機関名/Institute（機関選択不可の場合）

部署名/Department

個人名/Personal name

研究費提供組織/Funding Source

機関名/Organization

機関名/Institute
（機関選択不可の場合）

機関名/Organization
（機関選択不可の場合）