UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050628 |
|---|---|
| Receipt number | R000057672 |
| Scientific Title | Investigation of factors related to shortening the time required for dressing in patients with Parkinson's disease |
| Date of disclosure of the study information | 2023/03/28 |
| Last modified on | 2025/03/21 23:02:48 |
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Basic information
Public title
Investigation of factors related to shortening the time required for dressing in patients with Parkinson's disease
Acronym
Investigation of factors related to shortening the time required for dressing in patients with Parkinson's disease
Scientific Title
Investigation of factors related to shortening the time required for dressing in patients with Parkinson's disease
Scientific Title:Acronym
Investigation of factors related to shortening the time required for dressing in patients with Parkinson's disease
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
As the disease progresses, Parkinson's disease patients often require more time to put on clothes and require assistance. Occupational therapy for Parkinson's disease patients undergoing inpatient rehabilitation includes practice of putting on clothes. However, the factor that shortening the dressing time has not been clarified, and a standardized intervention method has not been established. Therefore, we clarify the factors related to the shortening of dressing time.
Basic objectives2
Others
Basic objectives -Others
In this study, hospitalized Parkinson's patients underwent self-training for 16 days (5 times in a row, 2 sets per day) and clarify the factors that shorten the dressing time of Parkinson's disease patients.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Dressing time
Key secondary outcomes
age, sex, disease duration, Levodopa equivalent daily dose, Hoehn & Yahr stage, Unified Parkinsin's Disease Rating Scale Part3, Japanese version of Montreal Cognitive Assessment, Serial Reaction Time Task
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
The intervention will be 16 days.Subjects practice dressing 10 times a day (5 times x 2 sets).
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
| 40 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Parkinson's disease
Age between 40 and 90
Hoehn & Yahe stage 1-4
Key exclusion criteria
Having a disease of the cranial nervous system other than Parkinson's disease
Range of shoulder flexion and abduction less than 90 degrees
Less than 21 points on the Japanese version of the Montreal Cognitive Assessment
Hoehn & Yahe stage 5
Target sample size
66
Research contact person
Name of lead principal investigator
| 1st name | So |
| Middle name | |
| Last name | Matsugashita |
Organization
Hyogo Prefectural Rehabilitation Hospital at Nisi-Harima
Division name
Department of Rehabilitation Therapy
Zip code
679-5165
Address
1-7-1, Kouto, Shingu-cho, Tatsuno-shi, Hyogo-ken, Japan
TEL
0791-58-1050
so.t.611@gmail.com
Public contact
Name of contact person
| 1st name | So |
| Middle name | |
| Last name | Matsugashita |
Organization
Hyogo Prefectural Rehabilitation Hospital at Nisi-Harima
Division name
Department of Rehabilitation Therapy
Zip code
679-5165
Address
1-7-1, Kouto, Shingu-cho, Tatsuno-shi, Hyogo-ken, Japan
TEL
0791-58-1050
Homepage URL
so.t.611@gmail.com
Sponsor or person
Institute
Hyogo Prefectural Rehabilitation Hospital at Nisi-Harima
Institute
Department
Personal name
Funding Source
Organization
Kobe University graduate school
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
Kobe University graduate school of Health Sciences
Address
7-10, Tomogaoka, Suma-ku, Kobe-shi, Hyogo-ken, Japan
Tel
078-792-2555
so.t.611@gmail.com
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 | 03 | Month | 28 | 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
| 2022 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 28 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | 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 | 03 | Month | 19 | Day |
Last modified on
| 2025 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057672
