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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044226
Receipt No. R000050507
Scientific Title Effects of motivation on stroke rehabilitation: a pilot study in physical therapy
Date of disclosure of the study information 2021/11/24
Last modified on 2021/05/17

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Basic information
Public title Effects of motivation on stroke rehabilitation
Acronym Effects of motivation on stroke rehabilitation
Scientific Title Effects of motivation on stroke rehabilitation: a pilot study in physical therapy
Scientific Title:Acronym Effects of motivation on stroke rehabilitation
Region
Japan

Condition
Condition Stroke
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of the study is to examine the effects of praise and active listening on intrinsic motivation of stroke patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Amount of exercise that a participant performed voluntarily on a cycle ergometer after intervention
Key secondary outcomes 1. Visual Analog Scale of motivation
2. Apathy scale
3. Geriatric Depression Scale

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
Blinding Single blind -participants are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 6
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 Five min of praise during cycling exercise / washout: more than 24 hours / 5 min of active listening / washout: more than 24 hours / 5 min of watchful waiting
Interventions/Control_2 Five min of praise during cycling exercise / washout: more than 24 hours / 5 min of watchful waiting / washout: more than 24 hours / 5 min of active listening
Interventions/Control_3 Five min of active listening during cycling exercise / washout: more than 24 hours / 5 min of praise / washout: more than 24 hours / 5 min of watchful waiting
Interventions/Control_4 Five min of active listening during cycling exercise / washout: more than 24 hours / 5 min of watchful waiting / washout: more than 24 hours / 5 min of praise
Interventions/Control_5 Five min of watchful waiting during cycling exercise / washout: more than 24 hours / 5 min of praise / washout: more than 24 hours / 5 min of active listening
Interventions/Control_6 Five min of watchful waiting during cycling exercise / washout: more than 24 hours / 5 min of active listening / washout: more than 24 hours / 5 min of praise
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
40 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria 1. Stroke patients
2. More than one month after stroke onset
3. A Mini Mental Status Examination score of >20 points. No higher brain dysfunction including aphasia
4. Patients who can use a bicycle ergometer more than 5 min.
5. Patients who can use a bicycle ergometer safely without risk of falling.
6. Patients who use a bicycle ergometer in their daily rehabilitation program
7. Patients who enter hospital more than one week
8. Patients who agree to participate in this study
Key exclusion criteria 1. Patients who meet withdraw criteria proposed by the Japanese Association of Rehabilitation Medicine
2. Patients who have arthrogryposis, orthopedic disease or pain that prevent them to perform motor tasks used in the study.
3. Patients who have neurological disease other than stroke
4. Patients who have psychiatric disease
5. Patients who are considered to be inappropriate to participate in the study
Target sample size 38

Research contact person
Name of lead principal investigator
1st name Kazuaki
Middle name
Last name Oyake
Organization Shinshu University
Division name Department of Physical Therapy
Zip code 390-8621
Address 3-1-1 Asahi, Matsumoto, Nagano, Japan
TEL 0263-37-2413
Email k_oyake@shinshu-u.ac.jp

Public contact
Name of contact person
1st name Kazuaki
Middle name
Last name Oyake
Organization Shinshu University
Division name Department of Physical Therapy
Zip code 390-8621
Address 3-1-1 Asahi, Matsumoto, Nagano, Japan
TEL 0263-37-2413
Homepage URL
Email k_oyake@shinshu-u.ac.jp

Sponsor
Institute Shinshu University
Institute
Department

Funding Source
Organization MEXT
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Kakeyu-Misayama Rehabilitation Center
Saku Central Hospital
Tokyo Bay Rehabilitation Hospital
Hamamatsu University School of Medicine
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethics committee of Shinshu University
Address 3-1-1 Asahi, Matsumoto, Nagano, Japan
Tel 0263-37-2572/+81-263-37-2572
Email mdrinri@shinshu-u.ac.jp/mdrinri@shinshu-u.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 鹿教湯三才山リハビリテーションセンター(長野県)
佐久総合病院(長野県)
東京湾岸リハビリテーション病院(千葉県)

Other administrative information
Date of disclosure of the study information
2021 Year 11 Month 24 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2021 Year 03 Month 05 Day
Date of IRB
2021 Year 03 Month 05 Day
Anticipated trial start date
2021 Year 05 Month 24 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 05 Month 17 Day
Last modified on
2021 Year 05 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050507

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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