UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056042 |
|---|---|
| Receipt number | R000062157 |
| Scientific Title | Analysis of clinical characteristics and rehabilitation effectiveness of Parkinson's disease in the elderly in Japan |
| Date of disclosure of the study information | 2024/11/05 |
| Last modified on | 2025/10/21 08:50:01 |
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Basic information
Public title
Analysis of physical characteristics and the effectiveness of rehabilitation of elderly patients with Parkinson's disease
Acronym
Analysis of physical characteristics and the effectiveness of rehabilitation of elderly patients with Parkinson's disease
Scientific Title
Analysis of clinical characteristics and rehabilitation effectiveness of Parkinson's disease in the elderly in Japan
Scientific Title:Acronym
Analysis of physical characteristics and the effectiveness of rehabilitation of elderly patients with Parkinson's disease
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study focused on PD patients aged 65 years and older and aimed to summarize the clinical characteristics and rehabilitation effect of the pre-old and old groups.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Demographic data
sex, age, age at onset, disease duration, H&Y stage, body mass index (BMI), Skeletal Muscle Index (SMI), blood test results, number of drugs (excluding anti-parkinsonian drugs), and anti-parkinsonian drugs), and motor and non-motor symptoms from the database of our institution.
Outcome measures
Unified Parkinson's Disease Rating Scale (UPDRS)
Montreal Cognitive Assessment-Japanese (MoCA-J)
Berg Balance Scale (BBS)
10-Meter Walking Test (10 MWT)
Functional Independence Measure (FIM).
Key secondary outcomes
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
| 65 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) diagnosis of PD has been diagnosed by two expert neurologist based on the UK Parkinsons Disease Society Brain Bank criteria, (2) Hoehn and Yahr (H&Y) stage 2-4, and (3) over 65 years of age.
Key exclusion criteria
(1) cerebrovascular disease or other complications affecting movement; (2) severe or unstable medical comorbid diseases; (3) suspected drug-induced parkinsonism due to dopamine receptor blocking agents, vascular parkinsonism, and atypical parkinsonism, such as progressive supranuclear palsy, multiple system atrophy, or corticobasal degeneration; and (4) Patients who experienced cognitive impairment within 1 year after the onset of PD.
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Toshiya |
| Middle name | |
| Last name | Shimamoto |
Organization
Kumamoto southern regional hospital
Division name
Department of Rehabilitation
Zip code
861-4214
Address
Mubanchi, Maihara, Jonan-machi, Minami-ku, Kumamoto City, Kumamoto, Japan
TEL
0964-28-2555
sentyoukansetu@icloud.com
Public contact
Name of contact person
| 1st name | Toshiya |
| Middle name | |
| Last name | Shimamoto |
Organization
Kumamoto southern regional hospital
Division name
Department of Rehabilitation
Zip code
861-4201
Address
Mubanchi, Maihara, Jonan-machi, Minami-ku, Kumamoto City, Kumamoto, Japan
TEL
0964-28-2555
Homepage URL
sentyoukansetu@icloud.com
Sponsor or person
Institute
Kumamoto southern regional hospital
Institute
Department
Personal name
Funding Source
Organization
No
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
Kumamoto southern regional hospital
Address
kumamoto southern regional hospital
Tel
0964-28-2555
sentyoukansetu@icloud.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
| 2024 | Year | 11 | Month | 05 | 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
Completed
Date of protocol fixation
| 2024 | Year | 01 | Month | 05 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 09 | Day |
Anticipated trial start date
| 2024 | Year | 05 | Month | 09 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2024 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2024 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2024 | Year | 06 | Month | 10 | Day |
Other
Other related information
Retrospectively extracted patients admitted to Kumamoto southern Regional Hospital from 2019 to 2021.
Management information
Registered date
| 2024 | Year | 11 | Month | 05 | Day |
Last modified on
| 2025 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062157
