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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043418
Receipt No. R000049572
Scientific Title Japanese Translation and Validation of the Lindop Parkinson's Physiotherapy Assessment Scale (LPA) in Patients with Parkinson's Disease
Date of disclosure of the study information 2021/02/22
Last modified on 2021/02/23

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Basic information
Public title Japanese Translation and Validation of the Lindop Parkinson's Physiotherapy Assessment Scale (LPA) in Patients with Parkinson's Disease
Acronym Japanese Translation and Validation of the LPA
Scientific Title Japanese Translation and Validation of the Lindop Parkinson's Physiotherapy Assessment Scale (LPA) in Patients with Parkinson's Disease
Scientific Title:Acronym Japanese Translation and Validation of the LPA
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 the most difficulty in getting up from bed in activities of daily living. However, there is no specialized measurement tool for evaluating the bed mobility that is the target of rehabilitation for patients with Parkinson's disease.
Therefore, we develop in the basic motor function of Parkinson's disease called "Lindop Parkinson's Physiotherapy Assessment Scale (abbreviated as LPA)" developed for medical staff in recent years. There is an evaluation method that has been verified, its reliability, validity, and reactivity have been verified, and it is already widely used internationally.
LPA is a battery that specializes in evaluating the two basic movements of Parkinson's disease patients (bed movement: 4 items, walking: 6 items). Scores are given to each item in 4 stages (0 to 3 points), and the higher the score, the higher the degree of independence.
The purpose of this study is to develop Japanese version of LPA, then confirm the validity and reliability of the Japanese version of the LPA.
Basic objectives2 Others
Basic objectives -Others To confirm the reliability and validity.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Gait (6items), Bed mobility (4items) from LPA
Key secondary outcomes MDS-UPDRS motor, 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
20 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 in-patients at Osaka University Hospital, Osaka, Japan.
Key exclusion criteria Patients could 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 Graduate School of Medicine Faculty of Medicine, Osaka University
Division name Department of Neurology
Zip code 565-0871
Address Yamadaoka2-2, Suita-city, Osaka
TEL 05055321220
Email m-pas@umin.ac.jp

Public contact
Name of contact person
1st name Seira
Middle name
Last name Taniguchi
Organization Graduate School of Medicine Faculty of Medicine, Osaka University
Division name Department of Neurology
Zip code 565-0871
Address Yamadaoka2-2, Suita-city, Osaka
TEL 050-5532-1224
Homepage URL
Email seira.taniguchi.pt@gmail.com

Sponsor
Institute Graduate School of Medicine Faculty of Medicine, Osaka University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Graduate School of Medicine Faculty of Medicine, Osaka University
Address Yamadaoka2-2, Suita-city, Osaka
Tel 06-6877-5111
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
2021 Year 02 Month 22 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
2021 Year 02 Month 22 Day
Date of IRB
Anticipated trial start date
2021 Year 04 Month 01 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The Japanese version of the LPA was translated with the permission of the developer, Fiona Lindop (University Hospitals of Derby & Burton NHS Foundation Trust). We are applying to Institutional Review Board.

Management information
Registered date
2021 Year 02 Month 22 Day
Last modified on
2021 Year 02 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049572

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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