UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049433 |
|---|---|
| Receipt number | R000056285 |
| Scientific Title | A single-center, nonrandomized, controlled study of the effect of Trunk Solution for patients with early-stage Parkinson's disease. |
| Date of disclosure of the study information | 2022/11/04 |
| Last modified on | 2022/11/04 18:31:51 |
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Basic information
Public title
Verification of the effect of a Trunk Solution Improves Posture for patients with Parkinson's Disease of Forward Bending Posture.
Acronym
Verification of the effect of a Trunk Solution for patients with Parkinson's Disease.
Scientific Title
A single-center, nonrandomized, controlled study of the effect of Trunk Solution for patients with early-stage Parkinson's disease.
Scientific Title:Acronym
PD study
Region
| Japan |
Condition
Condition
Parkinson's Disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Prospective evaluation of the effectiveness of a Trunk Solution Improves Posture for patients with Parkinson's Disease of Forward Bending Posture.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Measurement of the sagittal plane in the posture measurement device Spinal Mouse.
Key secondary outcomes
Target:Age,gender, main disease name,rehabilitation type(outpatient),Drug dosage
Frequency of use (times/week),period from start of use.
Disease severity:Hoehn-Yahr classification
Unified Parkinson's Disease Rating Scale Exercise Items
Gait function evaluation:10m walking
Functional Mobility Assessment:Timed Up & Go Test
Cognitive function Assessment:Mini-Mental State Examination
Balance Test:The Mini-Balance Evaluation Systems Test
Spine Measurement Analysis:Spinal Mouse,Upward Reach
Depression Assessment:Geriatric Depression Scale15
QOL assessment:Parkinson's Disease Questionnaire-39
Apathy Rating:Apathy Evaluation Scale
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
A combination of walking exercises and aerobic exercises with the Trunk Solution, with addition self-initiated training to ensure physical activity.The duration of participation is 2 months, with 2 interventions per week for 6 weeks, with 2 evaluations before and after each intervention.
Interventions/Control_2
Rehabilitation usually consists mainly of stretching, combined with aerobic exercise. The duration of participation is 2 months, with 1-2 interventions per week for 6 weeks, with 2 evaluations before and after each intervention.
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Parkinson's disease Hoehn-Yahr stage 1-3
2.Outpatients
Key exclusion criteria
Parkinson's disease Hoehn-Yahr stage 4-5
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kodai |
| Middle name | |
| Last name | Yamaguchi |
Organization
Nagasaki Kita Hospital
Division name
Deparetment of Rehabilitation
Zip code
851-2103
Address
800 Motomurago,Tokitsu-cho,Nishisonogi-gun,Nagasaki 851-2103,Japan
TEL
+81-866-8700
y.m.g.ch.ko@gmail.com
Public contact
Name of contact person
| 1st name | Kodai |
| Middle name | |
| Last name | Yamaguchi |
Organization
Nagasaki Kita Hospital
Division name
Deparetment of Rehabilitation
Zip code
851-2103
Address
800 Motomurago,Tokitsu-cho,Nishisonogi-gun,Nagasaki 851-2103,Japan
TEL
+81-866-8700
Homepage URL
http://www.shunkaikai.jp
y.m.g.ch.ko@gmail.com
Sponsor or person
Institute
Nagasaki Kita Hospital
Institute
Department
Personal name
Funding Source
Organization
Nagasaki Kita Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki Kita Hospital
Address
800 Motomurago,Tokitsu-cho,Nishisonogi-gun,Nagasaki 851-2103,Japan
Tel
+81-866-8700
y.m.g.ch.ko@gmail.com
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
| 2022 | Year | 11 | Month | 04 | 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
| 2022 | Year | 11 | Month | 04 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 18 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 07 | Day |
Last follow-up date
| 2024 | Year | 12 | 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
| 2022 | Year | 11 | Month | 04 | Day |
Last modified on
| 2022 | Year | 11 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056285
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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