UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049904 |
|---|---|
| Receipt number | R000053202 |
| Scientific Title | Intervention research on evaluation method and treatment intervention method for participants in occupational therapy. |
| Date of disclosure of the study information | 2022/12/26 |
| Last modified on | 2024/12/24 14:37:26 |
* 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
Intervention research on evaluation method and treatment intervention method for participants in occupational therapy.
Acronym
Intervention research on evaluation method and treatment intervention method for participants in occupational therapy.
Scientific Title
Intervention research on evaluation method and treatment intervention method for participants in occupational therapy.
Scientific Title:Acronym
Intervention research on evaluation method and treatment intervention method for participants in occupational therapy.
Region
| Japan |
Condition
Condition
Patients with neurological, neuropsychological, psychiatric or orthopedic diseases.
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the evaluation method to understand the characteristics of symptoms in patients subjected to occupational therapy and to clarify the relationship between the characteristics of symptoms and the intervention, which was based on the results from the examinations.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
One week after 3 weeks of occupational therapy intervention: physical function (motor function, sense function), cognitive function, activities of daily life, social participation.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
motor exercise task
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients who have occupational therapy prescription
2. Those who have higher-brain dysfunction and/or physical dysfunction.
3. Those who have consented to this study
Key exclusion criteria
1. Those with impaired consciousness
2. Those with reduced language comprehension
3. Those who have difficulty in oral expression
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hisaaki |
| Middle name | |
| Last name | Ota |
Organization
Sapporo Medical University
Division name
Department of Occupational Therapy, School of Health Sciences
Zip code
060-8556
Address
S1W17, Chuo-ku, Sapporo, Hokkaido
TEL
011-611-2111
hisoh@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Hisaaki |
| Middle name | |
| Last name | Ota |
Organization
Sapporo Medical University
Division name
Department of Occupational Therapy, School of Health Sciences
Zip code
060-8556
Address
S1W17, Chuo-ku, Sapporo, Hokkaido
TEL
011-611-2111
Homepage URL
hisoh@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University
Institute
Department
Personal name
Funding Source
Organization
Sapporo Medical University
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
Sapporo Medical University
Address
S1W17, Chuo-ku, Sapporo, Hokkaido
Tel
011-611-2111
ji-rskk@sapmed.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 12 | Month | 26 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 06 | Month | 20 | Day |
Date of IRB
| 2016 | Year | 08 | Month | 24 | Day |
Anticipated trial start date
| 2016 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2026 | 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
| 2022 | Year | 12 | Month | 26 | Day |
Last modified on
| 2024 | Year | 12 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053202
