UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034541 |
|---|---|
| Receipt number | R000039378 |
| Scientific Title | The effectiveness of pivot turn for gait disturbance in patients with Parkinson syndrome |
| Date of disclosure of the study information | 2018/11/01 |
| Last modified on | 2021/04/19 09:29:24 |
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Basic information
Public title
The effectiveness of pivot turn for gait disturbance in patients with Parkinson syndrome
Acronym
Pivot turn in patients with Parkinson syndrome
Scientific Title
The effectiveness of pivot turn for gait disturbance in patients with Parkinson syndrome
Scientific Title:Acronym
Pivot turn in patients with Parkinson syndrome
Region
| Japan |
Condition
Condition
Parkinson syndrome
Classification by specialty
| Neurology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to identify the efficacy of physical therapy including pivot turn for improvement of freeze of gait in patients with Parkinson syndrome
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The amount of change of the Timed and Go test score to improve physical therapy end two months later
Key secondary outcomes
time of timed up and go test
functional balance scale
10m gait speed
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Physical therapy for 2 months + observation for one month
Interventions/Control_2
observation for one month + Physical therapy for 2 months
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Parkinson syndrome patients with freeze of gait
Key exclusion criteria
Diabetic patients who has poor control
the past history of myocardial infarction
the past history of unstable angina
pregnancy or lactating woman
The patient who changed a dose of the antiParkinson disease medicine within one month before start
Artificial joint substituted art enforcement career
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshitaka Yamanaka |
Organization
Chiba University
Division name
Department of Neurology
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba 260-8670, Japan
TEL
+81-43-226-2129
y-yama@hospital.chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshitaka Yamanaka |
Organization
Chiba University
Division name
Department of Neurology
Zip code
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba 260-8670, Japan
TEL
+81-43-226-2129
Homepage URL
y-yama@hospital.chiba-u.jp
Sponsor or person
Institute
Department of Neurology, Chiba University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
self funding
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
千葉大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 11 | Month | 01 | 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
| 2018 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 21 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 10 | Month | 17 | Day |
Last modified on
| 2021 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039378
| 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 |
