UMIN-CTR Clinical Trial

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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