UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy validation of walking improvement devices using traction illusion for abnormal gait of Parkinson's disease
Title of the study (Brief title)	Efficacy validation of walking improvement device for abnormal gait of Parkinson's disease
Region	Japan

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

Objectives
Narrative objectives1	The verification of the improvement effect by the walking assistance device for gait disturbance of patients with Parkinson's disease
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Measurement time: intervention immediately before and after Item: stride, walking speed, cadence
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	10m walking in a state in which to below the knee part, was fitted with a device for presenting the traction illusion
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	20 years-old <=
Age-upper limit	80 years-old >=
Gender	Male
Key inclusion criteria	The Parkinson's disease patients who have no dementia and have the symptom of festinating gait as one of the gait disorders with Parkinson's disease.
Key exclusion criteria	The Parkinson's disease patients who have serious disorder cognitive ability or have no symptom of festinating gait as one of the gait disorders with Parkinson's disease.
Target sample size	20

Research contact person
Name of lead principal investigator	Hiroyasu Iwata
Organization	Waseda univ.
Division name	Dept. of Modern Mechanical Engineering
Address	Green Computing System Research Organization 40-603, 27, Waseda-cho, Shinjuku-ku, Tokyo
TEL	03-3203-4427
Email	jubi@waseda.jp

Public contact
Name of contact person	Hiroyasu Iwata
Organization	Waseda univ.
Division name	Dept. of Modern Mechanical Engineering
Address	Green Computing System Research Organization 40-603, 27, Waseda-cho, Shinjuku-ku, Tokyo
TEL	03-3203-4427
Homepage URL
Email	jubi@waseda.jp

Sponsor
Institute	Waseda University
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2015 Year 12 Month 16 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 08 Month 30 Day
Anticipated trial start date	2015 Year 12 Month 16 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 12 Month 10 Day
Last modified on	2017 Year 06 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023270