UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021054 |
|---|---|
| Receipt number | R000023723 |
| Scientific Title | Short-term effect of intensive physiotherapy rehabilitation on Parkinson's disease and neurodegenerative disorders |
| Date of disclosure of the study information | 2016/02/16 |
| Last modified on | 2019/03/01 18:13:00 |
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Basic information
Public title
Short-term effect of intensive physiotherapy rehabilitation on Parkinson's disease and neurodegenerative disorders
Acronym
Intensive physiotherapy rehabilitation on neurodegenerative disorders
Scientific Title
Short-term effect of intensive physiotherapy rehabilitation on Parkinson's disease and neurodegenerative disorders
Scientific Title:Acronym
Intensive physiotherapy rehabilitation on neurodegenerative disorders
Region
| Japan |
Condition
Condition
Parkinson's disease, multiple system atrophy, spinocerebellar degeneration, progressive supranuclear palsy, corticobasal degeneration, amyotrophic lateral sclerosis
Classification by specialty
| Neurology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate short-term effectiveness of intensive physiotherapy rehabilitation on Parkinson's disease and neurodegenerative disorders
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Time of up and go test
MDS-UPDRS
Key secondary outcomes
Time of 10 minutes walk
Power of hip joint flexure muscle
Functional reach test
Time of standing on one leg
Respiratory functions (%FVC and FEV1.0%)
SF-36
MDS-UPDRS subscale
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
No treatment
Interventions/Control_2
Voluntary training
Interventions/Control_3
Manual resistive exercise
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
| 89 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Inpatient who was admitted in order to confirm the diagnosis
Key exclusion criteria
1) Medical history of any other physical illness which can affect on motor functions
2) Activity is limited by cardiopulmonary dysfunction
3) Pregnant
4) Patient who perform any rehabilitation within 1 week before admission
Target sample size
270
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koji Abe |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Neurology
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama, 700-8558, Japan
TEL
086-235-7365
abekabek@cc.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kota Sato |
Organization
Okayama University hospital
Division name
Department of Neurology
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama, 700-8558, Japan
TEL
086-235-7365
Homepage URL
kosatou@cc.okayama-u.ac.jp
Sponsor or person
Institute
Okayama 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
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
岡山大学病院（岡山県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 16 | 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
| 2016 | Year | 02 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 17 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 16 | Day |
Last modified on
| 2019 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023723
| 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 |
