UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036262 |
|---|---|
| Receipt number | R000041300 |
| Scientific Title | Clinimetric analyses of Japanese translation of Modified Parkinson Activity Scale (M-PAS). |
| Date of disclosure of the study information | 2019/03/23 |
| Last modified on | 2021/12/22 17:22:30 |
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Basic information
Public title
Clinimetric analyses of Japanese translation of Modified Parkinson Activity Scale (M-PAS).
Acronym
Clinimetric analyses of Japanese translation of "M-PAS".
Scientific Title
Clinimetric analyses of Japanese translation of Modified Parkinson Activity Scale (M-PAS).
Scientific Title:Acronym
Clinimetric analyses of Japanese translation of "M-PAS".
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Patients with Parkinson's Disease have severe difficulties with bed mobility which is the initial and crucial step individuals must undertake every day. However, the evaluation of different movement strategies in patients with Parkinson's Disease, especially bed mobility, is difficult and currently no objective assessment tool for bed mobility is available yet in Japan.
The Modified Parkinson Activity Scale (M-PAS) has been introduced as a rating scale for functional mobility in Parkinson's Disease, which has been used throughout the world since M-PAS showed good concurrent validity and reliability. This scale consists of three domains: Chair Transfer, Gait Akinesia, and Bed Mobility.
The aim of this study is to confirm the reliability and validity of a Japanese translated version of the M-PAS in patients with Parkinson's disease.
Basic objectives2
Others
Basic objectives -Others
To confirm the reliability and validity.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The scores for a Japanese translated version of Modified Parkinson Activity Scale (M-PAS) such as Chair Transfer, Gait Akinesia, and Bed Mobility.
Key secondary outcomes
The scores for the revised Unified Parkinson's Disease Rating Scale (MDS-UODRS) Part III and the scores for the Mini Mental State Examination (MMSE).
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with idiopathic PD (Hoehn & Yahr stage I-IV) who are able to sit down/ stand up from a chair, walk, and get in/out of bed were enrolled in this study.
We recruited out-patients at Nishi-Harima Rehabilitation Hospital, Hyogo, Japan.
Key exclusion criteria
Subjects will be excluded if they had history of other neurologic or musculoskeletal disorders, severe orthopedic disease and pain that affected their strategies for sitting down/ standing up from a chair, gait, and getting in/out of bed.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Seira |
| Middle name | |
| Last name | Taniguchi |
Organization
Kobe University Graduate School
Division name
Department of Health Sciences
Zip code
654-0142
Address
7-10-2 Tomogaoka, Suma-ku, Kobe city, Hyogo, Japan.
TEL
078-792-2555
m-pas@umin.ac.jp
Public contact
Name of contact person
| 1st name | Seira |
| Middle name | |
| Last name | Taniguchi |
Organization
Kobe University Graduate School
Division name
Department of Health Sciences
Zip code
654-0142
Address
7-10-2 Tomogaoka, Suma-ku, Kobe city, Hyogo, Japan.
TEL
078-792-2555
Homepage URL
m-pas@umin.ac.jp
Sponsor or person
Institute
Hyogo Prefectural Rehabilitation Hospital at Nishi-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
Address
7-10-2 Tomogaoka, Suma-ku, Kobe city, Hyogo, Japan.
Tel
0791-58-1050
m-pas@umin.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
| 2019 | Year | 03 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
25
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
| 2019 | Year | 01 | Month | 18 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 18 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The research results have been published in the Progress in Rehabilitation Medicine (2021 Volume 6).
Validation and Reliability of the Japanese Version of the Modified Parkinson Activity Scale (M-PAS)
DOI https://doi.org/10.2490/prm.20210051
Management information
Registered date
| 2019 | Year | 03 | Month | 19 | Day |
Last modified on
| 2021 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041300
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