UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044226 |
|---|---|
| Receipt number | 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 | 2023/11/18 09:05:51 |
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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
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
k_oyake@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
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
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
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）
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
34
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
Completed
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
| 2023 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050507
