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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033454
Receipt No. R000034610
Scientific Title A study on the effectiveness of balance rehabilitation support robot (balance exercise assist robot) for Parkinson's patient.
Date of disclosure of the study information 2018/07/20
Last modified on 2018/07/19

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Basic information
Public title A study on the effectiveness of balance rehabilitation support robot (balance exercise assist robot) for Parkinson's patient.
Acronym A study on the effectiveness of balance rehabilitation support robot (balance exercise assist robot) for Parkinson's patient.
Scientific Title A study on the effectiveness of balance rehabilitation support robot (balance exercise assist robot) for Parkinson's patient.
Scientific Title:Acronym A study on the effectiveness of balance rehabilitation support robot (balance exercise assist robot) for Parkinson's patient.
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 effect of balance exercise assist robot for Parkinson's disease patients with balance disorder.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Balance Evaluation Systems Test.
Time point: pre, post, follow up 4W, and follow up 12W
Key secondary outcomes 10-m walk test and steps
Timed Up and Go test
tandem gait speed
continuous tandem gait steps
functional reach test
functional balance test
mini-Balance Evaluation Systems Test
Unified Parkinson's Disease Rating Scale
Parkinson's Disease Questionnaire-39
neurological psychological test
video shooting (frontal, and sagittal plane)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 robot assisted balance training (RABT)
The group is taken 40-minute / session, twice a week during 8-weeks. Total intervention sessions are 16.
Interventions/Control_2 traditional balance training (TBT)
The group is taken 40-minute / session, twice a week during 8-weeks. Total intervention sessions are 16.
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
40 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria Clinical diagnosis of Parkinson's disease
Hohen-Yahr stage I-III
Total score of BESTest < 75%
MMSE>=24 points
drug stability (past 3 month no change)
Key exclusion criteria 1
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name kazuhisa Domen
Organization Hyogo College of Medicine
Division name Department of physical medicine and rehabilitation
Zip code
Address 1-1, Mukogawa-cho, Nishinomiya, Hyogo
TEL 0798-45-6881
Email domen@neuro-reha.org

Public contact
Name of contact person
1st name
Middle name
Last name Koichiro Sota
Organization Hyogo College of Medicine Hospital
Division name Department of rehabilitation
Zip code
Address 1-1, Mukogawa-cho, Nishinomiya, Hyogo
TEL 0798-45-6358
Homepage URL
Email ksota@hyo-med.ac.jp

Sponsor
Institute Hyogo College of Medicine
Institute
Department

Funding Source
Organization nothing
Organization
Division
Category of Funding Organization Other
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 07 Month 20 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 Enrolling by invitation
Date of protocol fixation
2018 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 07 Month 19 Day
Last modified on
2018 Year 07 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034610

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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