UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033454 |
|---|---|
| Receipt number | 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 | 2022/07/22 09:26:29 |
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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 | Kazuhisa |
| Middle name | |
| Last name | Domen |
Organization
Hyogo College of Medicine
Division name
Department of physical medicine and rehabilitation
Zip code
6638501
Address
1-1, Mukogawa-cho, Nishinomiya, Hyogo
TEL
0798-45-6881
domen@neuro-reha.org
Public contact
Name of contact person
| 1st name | Koichiro |
| Middle name | |
| Last name | Sota |
Organization
Hyogo College of Medicine Hospital
Division name
Department of rehabilitation
Zip code
6638501
Address
1-1, Mukogawa-cho, Nishinomiya, Hyogo
TEL
0798-45-6358
Homepage URL
ksota@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
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
IRB, Hyogo College of Medicine
Address
1-1, Mukogawa-cho, Nishinomiya, Hyogo
Tel
0798-45-6066
rinri@hyo-med.ac.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
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
12
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
Completed
Date of protocol fixation
| 2018 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 16 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 10 | Month | 31 | Day |
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
| 2022 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034610
