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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000039024
Receipt No. R000044501
Scientific Title The effect of body weight supported overground training for patients with Parkinson's disease: case control trial
Date of disclosure of the study information 2020/01/06
Last modified on 2019/12/27

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Basic information
Public title The effect of body weight supported overground training
Acronym The effect of BWSOT
Scientific Title The effect of body weight supported overground training for patients with Parkinson's disease: case control trial
Scientific Title:Acronym The effect of BWSOT for patients with Parkinson's disease: case control trial
Region
Japan

Condition
Condition Parkinson's disease
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the effects of partially unloading walking exercise using a mobile hoist on motor function and disease severity for Parkinson's disease patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Patients without medication adjustment were measured before and 4 weeks after the intervention.
Unified Prkinson's Disease Rating Scale,10m Walk Test,Timed Up & Go Test,6minuts walking Distance,Berg Balance Scale
Key secondary outcomes Velocity,Stride length,Cadence,TUG Steps

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 Hoehn and Yahr2-4
No medicationadjustment or more than 1 week after adjustment.
Patients who can accurately measure all evaluation items.
Key exclusion criteria Patients with cerebrovascular disease or sequelae of cerebrovascular disease.
No complications affecting motor function.
Items for which evaluation items cannot be measured.
Patients who disagree with the study.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Hareaki
Middle name
Last name Seki
Organization Department of National Hospital Organization,Iwaki Hospital
Division name Department of Neurology
Zip code 971-8126
Address 88-1 Yago, Ona Hamanoda, Iwaki City, Fukushima Prefecture
TEL 0246-88-7101
Email seki.hareaki.er@mail.hosp.go.jp

Public contact
Name of contact person
1st name Yasuki
Middle name
Last name Koyanagi
Organization Department of National Hospital Organization,Iwaki Hospital.
Division name Department of Rehabilitation
Zip code 971-8126
Address 88-1 Yago, Ona Hamanoda, Iwaki City, Fukushima Prefecture.
TEL 0246-88-7101
Homepage URL
Email yasking9@gmail.com

Sponsor
Institute Department of National Hospital Organization,Iwaki Hospital.
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

IRB Contact (For public release)
Organization Iwaki Hospital Ethics Review Committee
Address 88-1 Yago, Ona Hamanoda, Iwaki City, Fukushima Prefecture.
Tel 0246-88-7101
Email koyanagi.yasuki.sf@mail.hosp.go.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 独立行政法人国立病院機構いわき病院(福島県)

Other administrative information
Date of disclosure of the study information
2020 Year 01 Month 06 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 40
Results Unified Prkinson's Disease Rating Scale,10m Walk Test,Timed Up & Go Test,6minuts walking Distance.
Results date posted
2019 Year 12 Month 27 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics Parkinson's disease patient admitted to Iwaki Hospital
Participant flow Intervene after rehabilitation prescription and conduct test measurement. Re-evaluation after 4 weeks of BWSOT or regular rehabilitation.
Adverse events None
Outcome measures Unified Prkinson's Disease Rating Scale,10m Walk Test,Timed Up & Go Test,6minuts walking Distance.
Plan to share IPD None
IPD sharing Plan description Management within the Iwaki Hospital network system

Progress
Recruitment status Completed
Date of protocol fixation
2017 Year 04 Month 01 Day
Date of IRB
2019 Year 11 Month 21 Day
Anticipated trial start date
2017 Year 04 Month 01 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
2019 Year 03 Month 31 Day
Date trial data considered complete
2019 Year 03 Month 31 Day
Date analysis concluded
2020 Year 03 Month 31 Day

Other
Other related information A retrospective study of the effects of regular rehabilitation and BWSOT.

Management information
Registered date
2019 Year 12 Month 27 Day
Last modified on
2019 Year 12 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044501

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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