UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033893 |
|---|---|
| Receipt number | R000038657 |
| Scientific Title | Immediate effects of split-belt treadmill training on gait asymmetry in Parkinson's disease |
| Date of disclosure of the study information | 2018/08/25 |
| Last modified on | 2018/08/25 13:43:52 |
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Basic information
Public title
Immediate effects of split-belt treadmill training on gait asymmetry in Parkinson's disease
Acronym
Split-belt treadmill training in Parkinson's disease
Scientific Title
Immediate effects of split-belt treadmill training on gait asymmetry in Parkinson's disease
Scientific Title:Acronym
Split-belt treadmill training 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 immediate effects of split-belt treadmill training on gait asymmetry in Parkinson's disease
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I,II
Assessment
Primary outcomes
Step length, duration of swing phase and stance phase in each side and symmetry index of each outcome measures
Key secondary outcomes
Timed up and go test
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Split-belt treadmill training(single session. 10 minutes per session)
Interventions/Control_2
Treadmill training(single session. 10 minutes per session)
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
Key exclusion criteria
1. Severe motor fluctuations
2. History of other neurological disorders, severe orthopedic disease of lower lim and cardiovascular disease
3. Presence of cardiac pace maker
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yohei Okada |
Organization
Kio University
Division name
Department of Physical Therapy, Faculty of Health Sciences
Zip code
Address
4-2-2 umami-naka koryo-cho, kitakatsuragi-gun, Nara, 635-0832 JAPAN
TEL
+81-745-54-1601
y.okada@kio.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yohei Okada |
Organization
Kio University
Division name
Department of Physical Therapy, Faculty of Health Sciences
Zip code
Address
4-2-2 umami-naka koryo-cho, kitakatsuragi-gun, Nara, 635-0832 JAPAN
TEL
+81-745-54-1601
Homepage URL
y.okada@kio.ac.jp
Sponsor or person
Institute
Department of Physical Therapy, Faculty of Health Sciences, Kio University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, culture, Sports, Science and Technology
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
| 2018 | Year | 08 | Month | 25 | 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
| 2018 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 08 | Month | 25 | Day |
Last modified on
| 2018 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038657
