UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050206 |
|---|---|
| Receipt number | R000057175 |
| Scientific Title | Quantitative assessment of the gait improvement effect of LSVT(R) BIG in patients with Parkinson's disease |
| Date of disclosure of the study information | 2023/02/01 |
| Last modified on | 2023/08/03 14:14:46 |
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Basic information
Public title
Quantitative assessment of the gait improvement effect of LSVT(R) BIG in patients with Parkinson's disease
Acronym
Quantitative assessment of the gait through LSVT BIG
Scientific Title
Quantitative assessment of the gait improvement effect of LSVT(R) BIG in patients with Parkinson's disease
Scientific Title:Acronym
Quantitative assessment of the gait through LSVT(R) BIG
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of rehabilitation and the characteristics of pathological gait in patients with Parkinson's disease, we will measure and analyze the spatiotemporal parameters of gait before and after LSVT BIG using a gait analysis system (RehaGait).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gait parameters obtained by RehaGait within 7 days before beginning and after finishing LSVT-BIG, especially the angles of the lower extremities
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who are 20 years of age or older with Parkinson's disease and able to walk on their own.
2) Having a will to receive LSVT BIG at JA Nagano Koseiren Kakeyu Misayama Rehabilitation Center Kakeyu Hospital as an outpatient or inpatient.
3) Eligible for receiving LSVT-BIG therapy.
Key exclusion criteria
1) Patients who are classified as Hoehn-Yahr grade V (most severe disease: patients basically need full assistance in daily living).
2) Patients with dementia (LSVT BIG includes exercises that require patients to make efforts on their own).
3) Patients deemed inappropriate by the principal investigator.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yoshiki |
| Middle name | |
| Last name | Sekijima |
Organization
Shinshu University School of Medicine
Division name
Department of Medicine (Neurology and Rheumatology)
Zip code
390-0861
Address
3-1-1 Asahi, Matsumoto
TEL
0263-37-2673
sekijima@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Atsuhiro |
| Middle name | |
| Last name | Matsuno |
Organization
Shinshu University School of Medicine
Division name
Department of Medicine (Neurology and Rheumatology)
Zip code
390-0861
Address
3-1-1 Asahi, Matsumoto
TEL
0263-37-2673
Homepage URL
atsuhiro@shinshu-u.ac.jp
Sponsor or person
Institute
Other
Institute
Department
Personal name
Atsuhiro Matsuno
Funding Source
Organization
Other
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
the Ethics Committee of Shinshu University School of Medicine
Address
3-1-1 Asahi, Matsumoto
Tel
0263-37-2572
mdrinri@shinshu-u.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
| 2023 | Year | 02 | Month | 01 | 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
24
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
| 2020 | Year | 02 | Month | 04 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 04 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 25 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The following measurements are assessed through LSVT BIG.
1) Spatiotemporal gait parameters and the angles of the joints in the lower extremities obtained by RehaGait during 10 m walking
2) MDS-UPDRS, Timed Up and Go test, FIM
Management information
Registered date
| 2023 | Year | 02 | Month | 01 | Day |
Last modified on
| 2023 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057175
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
