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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036262
Receipt No. 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 2019/10/02

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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
Email 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
Email m-pas@umin.ac.jp

Sponsor
Institute Hyogo Prefectural Rehabilitation Hospital at Nishi-Harima
Institute
Department

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
Email 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 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 Open public recruiting
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
2019 Year 11 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Cross-sectional correlational study

Management information
Registered date
2019 Year 03 Month 19 Day
Last modified on
2019 Year 10 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041300

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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