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利用者名:
UMIN ID:

試験進捗状況 試験終了/Completed
UMIN試験ID UMIN000042960
受付番号 R000049044
科学的試験名
一般公開日(本登録希望日) 2021/01/10
最終更新日 2021/01/10

※ 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
Stretching exercises for Hamstring group of muscles.
一般向け試験名略称/Acronym
Stretching exercises.
科学的試験名/Scientific Title
Comparative study of three different techniques to increase active and passive
hamstring flexibility - a randomized controlled trial.
科学的試験名略称/Scientific Title:Acronym
Comparative study for three stretching techniques - RCT.
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
Hamstring tightness.
疾患区分1/Classification by specialty
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
The purpose of this study was to compare the effectiveness of Static stretching, Cupping
therapy and Self Myofascial release, on active and passive flexibility of hamstring muscle group using AKE, PSLR and SRT.
目的2/Basic objectives2 その他/Others
目的2 -その他詳細/Basic objectives -Others
Active versus passive comparison.
試験の性質1/Trial characteristics_1 検証的/Confirmatory
試験の性質2/Trial characteristics_2
試験のフェーズ/Developmental phase 該当せず/Not applicable

評価/Assessment
主要アウトカム評価項目/Primary outcomes
Active knee extension (AKE)
Passive straight leg raise test (PSLR)
副次アウトカム評価項目/Key secondary outcomes
Sit and reach test (SRT)

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 並行群間比較/Parallel
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 オープン/Open -no one is blinded
コントロール/Control 実薬・標準治療対照/Active
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 施設を考慮していない/Institution is not considered as adjustment factor.
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 3
介入の目的/Purpose of intervention 予防・検診・検査/Prevention
介入の種類/Type of intervention
手技/Maneuver
介入1/Interventions/Control_1
Self-Myofascial release-The participant assumed a long sitting position on a firm and even surface by placing the
arms backward and loading body weight on the palms. A foam roller was placed under the
hamstrings and slowly moved back and forth from the ischial tuberosity to the popliteus, by
applying pressure for 4 minutes (2 min for each leg) for 3 days at the same time of day at 24
hour interval
介入2/Interventions/Control_2
Cupping therapy-The cupping technique involved the static cupping
application for 7 minutes. The cupping intervention was performed using JINKANG B242
Cupping set. The participant lie down in prone position, a thin layer of lotion was applied to
the hamstring and cups are placed on the trigger point. The assigned intervention was applied bilaterally to all participants and they were asked to
continue their normal weekly exercise or activity routine. Follow up measurement was taken
after 1 week of intervention.
介入3/Interventions/Control_3
Static stretching -Participants were in supine lying position with tested leg in active knee extension test position,
therapist passively extend the knee until the participant feels the intolerable stretch. This
procedure was repeated for 3 times with 30 sec hold and 10 seconds interval in between each
stretch for consecutive 5 days and follow up was taken on 8 th day
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
18 歳/years-old より上/<
年齢(上限)/Age-upper limit
30 歳/years-old 未満/>
性別/Gender 男女両方/Male and Female
選択基準/Key inclusion criteria
BMI between 18.5-24.9, hamstring are tight and passive SLR range between 30-70, at
least 15-20 degree loss of knee extension when hip held in 90 degree flexion, participants with
less than 12 inches in Sit and reach test and Stretch end feel during complete range of motion
除外基準/Key exclusion criteria
past history of hamstring injury within 2 years, Low joint mobility or
hypermobility, Metabolic disease, Incomplete post fracture bone fusion, Lumbar and lower
limb neurological compromise, Limb length discrepancy, Acute joint pain with exercise,
Straight leg, hip flexion range of motion was greater than 70 degree. Ethical approval for this
randomised study was granted by, NTCC committee of AIPT, AUUP, A+ orthopaedic and
sports Med Centre. Informed consent was obtained from all participants and any relevant
questions answered on data collection, all concerned were aware of the right to withdraw from
the study at any time.
目標参加者数/Target sample size 45

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

ミドルネーム

Mayank
ミドルネーム -
Shukla
所属組織/Organization
Amity Institute of Physiotherapy, Amity University, UP
所属部署/Division name
Uttar Pradesh Noida
郵便番号/Zip code 201303
住所/Address
F1 LGF Sector 125, Noida UP India
電話/TEL 01204392000
Email/Email mshukla@amity.edu

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

Mayank
ミドルネーム
Shukla
組織名/Organization
Amity Institute of Physiotherapy, Amity University, UP
部署名/Division name
Uttar Pradesh Noida
郵便番号/Zip code 201303
住所/Address
F1 LGF Sector 125, Noida UP India
電話/TEL 911204392000
試験のホームページURL/Homepage URL https://www.amity.edy/aipt
Email/Email mshukla@amity.edu

実施責任組織/Sponsor
機関名/Institute その他 Amity Institute of Physiotherapy
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 NA-Self
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 自己調達/Self funding
研究費拠出国/Nationality of Funding Organization
India

その他の関連組織/Other related organizations
共同実施組織/Co-sponsor
NA
その他の研究費提供組織/Name of secondary funder(s)
NA

IRB等連絡先(公開)/IRB Contact (For public release)
組織名/Organization
Amity Institute of Physiotherapy
住所/Address
F1 LGF, AIPT, AUUP, Noida, India, 201313
電話/Tel 0120-4392000
Email/Email mshukla@amity.edu

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 Amity Institute of Physiotherapy
A+ Orthopaedic centre

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
2021 01 10

関連情報/Related information
プロトコル掲載URL/URL releasing protocol NA
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 NA
組み入れ参加者数/Number of participants that the trial has enrolled 48
主な結果/Results
result show different effects. Passive interventions affect passive flexibility. Active interventions increase active flexibility.
主な結果入力日/Results date posted
2021 01 10
結果掲載遅延/Results Delayed
結果遅延理由/Results Delay Reason
na
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
Table 2 Showing mean and standard deviation of different groups with descriptive
parameters. To summarize, this table shows mean and standard deviation of various
parameters like, age, height, weight and BMI of GROUP-1, GROUP-2 and GROUP-3.
Mean age was 21.66 to 25.13
BMI was less than 24.9.
参加者の流れ/Participant flow
N=60 assessed, 48 selected & randomized
15 excluded
45 randomized completed study
有害事象/Adverse events
NA
評価項目/Outcome measures
AKE
PSLR
SRT
個別症例データ共有計画/Plan to share IPD
Publication is planned
個別症例データ共有計画の詳細/IPD sharing Plan description
Publication is planned

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
2020 01 10
倫理委員会による承認日/Date of IRB
2020 02 08
登録・組入れ開始(予定)日/Anticipated trial start date
2020 02 10
フォロー終了(予定)日/Last follow-up date
2020 07 30
入力終了(予定)日/Date of closure to data entry
2020 08 03
データ固定(予定)日/Date trial data considered complete
2020 08 03
解析終了(予定)日/Date analysis concluded
2020 10 10

その他/Other
その他関連情報/Other related information
The study was completed in the year 2020, and publication is planned in 2021. Results are not getting entered in the section given - One-way ANOVA in the follow-up analysis of three groups has shown a
significant variation in the AKE (p= 0.013*), and PSLR (p= 0.019*). In parallel analysis
using unpaired t test - post intervention analysis , SRT has shown better result for
SMFR versus SS (p = 0.018), AKE has shown better result for SS versus CTh
(p=0.043), and PSLR has shown better result for CTh versus SMFR (p=0.02); followup analysis , SRT has shown better result for SMFR versus SS (p=0.04), and SMFR
versus CTh (p=0.012), AKE has shown better results for SMFR versus SS (p= 0.045 ),
and SMFR versus CTh (p=0.0035 ), PSLR has shown better results for CTh versus
SMFR (p= 0.004), and SS versus SMFR (p= 0.025).

管理情報/Management information
登録日時/Registered date
2021 01 10
最終更新日/Last modified on
2021 01 10


閲覧ページへのリンク/Link to view the page
URL(日本語) https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000049044
URL(英語) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049044

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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