UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035163 |
|---|---|
| Receipt number | R000040076 |
| Scientific Title | Effects of postural deformity on gait in Parkinson's disease |
| Date of disclosure of the study information | 2018/12/07 |
| Last modified on | 2023/06/24 21:33:57 |
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Basic information
Public title
Effects of postural deformity on gait in Parkinson's disease
Acronym
Postural deformity and gait in Parkinson's disease
Scientific Title
Effects of postural deformity on gait in Parkinson's disease
Scientific Title:Acronym
Postural deformity and gait in 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
To investigate the effects of postural deformity on gait in Parkinson's disease
Basic objectives2
Others
Basic objectives -Others
We investigate the relationship between posture deformity and gait and help to develop effective rehabilitation programs.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Kinematic,kinetic and spatiotemporal prameters of sitting,standing and walking
Key secondary outcomes
New Freezing of Gait Questionnaire
Movement Disorders Society-sponsored revision of the Unified Parkinson's Disease Rating Scale
Maximal isometric muscle strength
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.diagnosis of Parkinson's disease
2.walking ability for a short distance(10m) without use of device
Key exclusion criteria
1.history of other neurological disorders,severe orthopedic disease of lower limb and cardiovascular disease
2.difficulty understanding instructions
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hideyuki |
| Middle name | |
| Last name | Urakami |
Organization
Osaka Medical and Pharmaceutical University Hospital
Division name
Department of Rehabilitation
Zip code
5698686
Address
2-7,College-cho,Takatsuki-shi,Osaka 569-8686
TEL
072-683-1221
hideyuki.urakami@ompu.ac.jp
Public contact
Name of contact person
| 1st name | Hideyuki |
| Middle name | |
| Last name | Urakami |
Organization
Osaka Medical and Pharmaceutical University Hospital
Division name
Department of Rehabilitation
Zip code
5698686
Address
2-7,College-cho,Takatsuki-shi,Osaka 569-8686
TEL
072-683-1221
Homepage URL
hideyuki.urakami@ompu.ac.jp
Sponsor or person
Institute
Osaka Medical and Pharmaceutical University
Institute
Department
Personal name
Funding Source
Organization
No funding source
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Mihara Memorial Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethics committee at Osaka Medical and Pharmaceutical University
Address
2-7,College-cho,Takatsuki-shi,Osaka 569-8686
Tel
0726831221
rinri@ompu.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
大阪医科薬科大学病院（大阪府）、畿央大学（奈良県）、美原記念病院（群馬）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 12 | Month | 07 | 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
| 2018 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
We investigate the effects of postural deformity on gait in Parkinson's disease.
Management information
Registered date
| 2018 | Year | 12 | Month | 07 | Day |
Last modified on
| 2023 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040076
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
