UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043418 |
|---|---|
| Receipt number | 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 | 2024/01/10 14:46:33 |
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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
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
m-pas@umin.ac.jp
Sponsor or person
Institute
Graduate School of Medicine Faculty of Medicine, Osaka University
Institute
Department
Personal name
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
rinri#hp-crc.med.osaka-u.ac.jp (please replace # into @)
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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 02 | Month | 22 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 05 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2025 | 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). This study has been approved by the research ethics committee at Osaka University Hospital.
Management information
Registered date
| 2021 | Year | 02 | Month | 22 | Day |
Last modified on
| 2024 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049572
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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