UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033893
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email y.okada@kio.ac.jp

Sponsor
Institute Department of Physical Therapy, Faculty of Health Sciences, Kio University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038657

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.