UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051862 |
|---|---|
| Receipt number | R000059170 |
| Scientific Title | Motivating rehabilitation based on self-determination theory |
| Date of disclosure of the study information | 2023/08/08 |
| Last modified on | 2023/08/08 11:10:11 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Motivating rehabilitation based on self-determination theory
Acronym
Motivating rehabilitation based on self-determination theory
Scientific Title
Motivating rehabilitation based on self-determination theory
Scientific Title:Acronym
Motivating rehabilitation based on self-determination theory
Region
| Japan |
Condition
Condition
Cerebrovascular disorders, medical diseases, etc.
Patients eligible for rehabilitation
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the impact of rehabilitation interventions with need-supportive behaviours on rehabilitation outcomes such as motivation and ADLs, mediated by the fulfilment of autonomy needs and competence needs.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Functional independence Measure (FIM)
Key secondary outcomes
Motivation for rehabilitation: Behavioral Regulation Exercise Questionnaire (BREQ-4)
willingness to participate in rehabilitation: Pittsburgh Rehabilitation Participation Scale(PRPS)
basic psychological needs: Psychological need satisfaction in exercise scale (PNSE)
need-supportive behaviours: Japanese version of the Interpersonal Behaviours Questionnaire (IBQ-J)
Patient Health Questionnaire-9(PHQ-9)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
need-supportive behaviours + Occupational therapy
Interventions/Control_2
Occupational therapy
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients admitted to Shizuoka Medical Centre who require rehabilitation
Key exclusion criteria
1)severe impairment of consciousness
2)those with difficulty in understanding or expressing sentences, such as aphasia
3)those with a history of mental illness such as depression or schizophrenia
4)severe cognitive impairment
5)those who are unable to perform voluntary rehabilitation due to unstable general condition
6)other patients who are judged by the principal investigator to be unsuitable as research subjects
Target sample size
128
Research contact person
Name of lead principal investigator
| 1st name | Takeyuki |
| Middle name | |
| Last name | Suzuki |
Organization
National Hospital Organization Shizuoka Medical Center
Division name
Department of Rehabilitation
Zip code
411-8611
Address
762-1 Nagasawa, Shimizu-cho, Sunto-gun, Shizuoka Prefecture
TEL
055-975-2000
suzuki.takeyuki.wa@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | Takeyuki |
| Middle name | |
| Last name | Suzuki |
Organization
National Hospital Organization Shizuoka Medical Center
Division name
Department of Rehabilitation
Zip code
411-8611
Address
762-1 Nagasawa, Shimizu-cho, Sunto-gun, Shizuoka Prefecture
TEL
055-975-2000
Homepage URL
suzuki.takeyuki.wa@mail.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Shizuoka Medical Center
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Shizuoka Medical Center
Address
762-1 Nagasawa, Shimizu-cho, Sunto-gun, Shizuoka Prefecture
Tel
055-975-2000
suzuki.takeyuki.wa@mail.hosp.go.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 08 | Month | 08 | 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
| 2023 | Year | 06 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 08 | Month | 08 | Day |
Last follow-up date
| 2025 | 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
| 2023 | Year | 08 | Month | 08 | Day |
Last modified on
| 2023 | Year | 08 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059170
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
