UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050866 |
|---|---|
| Receipt number | R000057966 |
| Scientific Title | Trial of electrical stimulation therapy for Parkinson's disease patients with postural abnormalities |
| Date of disclosure of the study information | 2023/04/17 |
| Last modified on | 2023/04/17 13:57:56 |
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Basic information
Public title
Trial of electrical stimulation therapy for Parkinson's disease patients with postural abnormalities
Acronym
Trial of electrical stimulation therapy for Parkinson's disease patients with postural abnormalities
Scientific Title
Trial of electrical stimulation therapy for Parkinson's disease patients with postural abnormalities
Scientific Title:Acronym
Trial of electrical stimulation therapy for Parkinson's disease patients with postural abnormalities
Region
| Japan |
Condition
Condition
Parkinson's disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the immediate effect of single-trial intervention on standing posture, muscle strength, pain, and walking ability in order to obtain basic knowledge for the future prospect of validating the effectiveness of a combined approach of exercise therapy and electrical stimulation therapy for postural abnormalities in PD patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
Static standing alignment
Key secondary outcomes
trunk flexion and extension muscle strength, dynamic walking ability
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Exercise therapy single intervention
Interventions/Control_2
Combined intervention of exercise therapy and electrical stimulation therapy
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with postural abnormalities of 2 or more points in MDS-UPDRS III-13 posture and chronic low back pain lasting more than 3 months, and who have given consent for this study.
Key exclusion criteria
Patients with acute neurological symptoms (impaired consciousness, epileptic seizures)
Patients with radiographic evidence of inflammatory disease, tumors, spondylolysis, spondylolisthesis, sacroiliitis, etc.
Patients with medical conditions that contraindicate exercise
Patients with neuromuscular diseases or skin diseases in the abdomen or lumbar region.
Patients with a cardiac pacemaker
Patients with spinal contractures
Those who have stage 5 (slightly severe cognitive decline) or higher on the Functional Assessment Staging.
Those who require the assistance of another person for gait function assessment.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Yoshiki |
| Middle name | |
| Last name | Katou |
Organization
Medical Corporation Kayoukai Kawaguchi Neurosurgery Rehabilitation Clinic
Division name
Department of Rehabilitation
Zip code
5730086
Address
9-25-202 Kourien-cho, Hirakata City, Osaka, Japan
TEL
0728351010
kawaguchi.ns.reha@gmail.com
Public contact
Name of contact person
| 1st name | Shinya |
| Middle name | |
| Last name | Iki |
Organization
Medical Corporation Kayoukai Kawaguchi Neurosurgery Rehabilitation Clinic
Division name
Department of Rehabilitation
Zip code
5730086
Address
9-25-202 Kourien-cho, Hirakata City, Osaka, Japan
TEL
0728351010
Homepage URL
kawaguchi.ns.reha@gmail.com
Sponsor or person
Institute
Medical Corporation Kayoukai Kawaguchi Neurosurgery Rehabilitation Clinic
Institute
Department
Personal name
Funding Source
Organization
Japan Physical Therapy Society
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
Medical Corporation Kayoukai Kawaguchi Neurosurgery Rehabilitation Clinic
Address
9-25-202 Kourien-cho, Hirakata City, Osaka, Japan
Tel
08052153629
kawaguchi.ns.reha@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
| 2023 | Year | 04 | Month | 17 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 03 | Month | 22 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 29 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 29 | Day |
Last follow-up date
| 2023 | Year | 08 | 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
| 2023 | Year | 04 | Month | 17 | Day |
Last modified on
| 2023 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057966
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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