UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025462 |
|---|---|
| Receipt number | R000029303 |
| Scientific Title | Group-based multidisciplinary rehabilitation for Parkinson's disease: An in-patient approach |
| Date of disclosure of the study information | 2016/12/28 |
| Last modified on | 2018/12/07 14:11:50 |
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Basic information
Public title
Group-based multidisciplinary rehabilitation for Parkinson's disease: An in-patient approach
Acronym
Group-based rehabilitation for Parkinson's disease
Scientific Title
Group-based multidisciplinary rehabilitation for Parkinson's disease: An in-patient approach
Scientific Title:Acronym
Group-based rehabilitation for Parkinson's disease
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology | Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We assessed the effect of group-based multidisciplinary rehabilitation for Parkinson's disease.
Basic objectives2
Others
Basic objectives -Others
1-year follow-up
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
UPDRS parts 1-4
Key secondary outcomes
MMSE, FAB, SDS
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Group-based multidisciplinary rehabilitation for in-patients with Parkinson's disease for 5 weeks
Interventions/Control_2
Individual-based multidisciplinary rehabilitation for in-patients with Parkinson's disease for 5 weeks
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
| 50 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Eligibility criteria included a clinical diagnosis of PD with a disease severity rating of stage 3 to 4 on the Hoehn and Yahr scale,stable medication use, medical clearance for participation, and willingness to participate in treatment and outcome testing.
Key exclusion criteria
Exclusion criteria were current participation in any other behavioral or pharmacologic study or debilitating conditions that would impede full participation.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takao Mitsui |
Organization
Tokushima National Hospital, National Hospital Organization
Division name
Department of Clinical Research
Zip code
Address
1354 Shikiji, Kamojima, Yoshinogawa, Tokushima 776-0031 Japan
TEL
0883-24-2161
tmitsui@tokushima-nh.hosp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Arisa Shimizu |
Organization
Tokushima National Hospital, National Hospital Organization
Division name
Department of Clinical Research
Zip code
Address
1354 Shikiji, Kamojima, Yoshinogawa, Tokushima 776-0031 Japan
TEL
0883-24-2161
Homepage URL
rinsyou@tokushima-nh.hosp.go.jp
Sponsor or person
Institute
Department of Clinical Research, Tokushima National Hospital, National Hospital Organization
Institute
Department
Personal name
Funding Source
Organization
JPS
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2016 | Year | 12 | Month | 28 | 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
| 2014 | Year | 04 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 12 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 28 | Day |
Last modified on
| 2018 | Year | 12 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029303
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
