UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059747 |
|---|---|
| Receipt number | R000068324 |
| Scientific Title | An observational study on treatments for postural abnormalities in Parkinson's disease and related disorders |
| Date of disclosure of the study information | 2025/11/12 |
| Last modified on | 2025/11/12 13:35:54 |
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Basic information
Public title
An observational study on treatments for postural abnormalities in Parkinson's disease and related disorders
Acronym
An observational study on treatments for postural abnormalities in Parkinson's disease and related disorders
Scientific Title
An observational study on treatments for postural abnormalities in Parkinson's disease and related disorders
Scientific Title:Acronym
An observational study on treatments for postural abnormalities in Parkinson's disease and related disorders
Region
| Japan |
Condition
Condition
Parkinson's disease and related disorders
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A medical record review will be conducted at the NCNP to examine the treatment methods and duration of therapy for postural abnormalities. The aim is to evaluate the efficacy and safety of these treatments.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint is improvement in posture (flexion angle), and the secondary endpoint is improvement in activities of daily living (ADL).
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients who received treatment for postural abnormalities at our hospital by March 31, 2030, after the start of the study.
2. Patients who received an explanation of this study, understood its purpose, and provided informed consent to participate.
Key exclusion criteria
1. Individuals who are minors or who are unable to express their intention to provide informed consent.
2. Individuals deemed inappropriate for inclusion by the principal investigator.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Yohei |
| Middle name | |
| Last name | Mukai |
Organization
National Center Hospital, National Center of Neurology and Psychiatry
Division name
Department of neurology
Zip code
187-8551
Address
4-1-1 Ogawahigashicho, Kodaira, Tokyo, 187-8551, Japan
TEL
+81-42-341-2711
ymukai@ncnp.go.jp
Public contact
Name of contact person
| 1st name | Yohei |
| Middle name | |
| Last name | Mukai |
Organization
National Center Hospital, National Center of Neurology and Psychiatry
Division name
Department of neurology
Zip code
187-0025
Address
4-1-1 Ogawahigashicho, Kodaira, Tokyo, 187-8551, Japan
TEL
+81-42-341-2711
Homepage URL
ymukai@ncnp.go.jp
Sponsor or person
Institute
National Research and Development Agency, NNational Center of Neurology and Psychiatry
Institute
Department
Personal name
Funding Source
Organization
National Research and Development Agency, NNational Center of Neurology and Psychiatry
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Ethics Committee of NCNP
Address
4-1-1, Ogawahigashicho, Kodaira, Tokyo, 187-8551, Japan
Tel
+81-42-341-2712
rinri-jimu@ncnp.go.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
| 2025 | Year | 11 | Month | 12 | 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
| 2025 | Year | 05 | Month | 02 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 02 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 02 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In this study, a medical record review will be conducted on the evaluation and rehabilitation of postural abnormalities performed as part of standard medical care.
At our institution, the evaluation items for postural abnormalities include:
1. Measurement of flexion angle from standing whole-body photographs (frontal and lateral views);
2. Assessment of trunk inclination during gait using an accelerometer;
3. Skeletal X-rays;
4. Posturography and limits of stability testing;
5. Gait analysis;
6. Muscle tone assessment (using noninvasive methods such as palpation, elastography, or muscle hardness measurement);
7. Neurological examination and questionnaires (e.g., MDS-UPDRS, FIM);
8. Skeletal muscle CT or paraspinal muscle MRI;
9. Electromyography (EMG);
10. Motor evoked potentials (MEP);
11. Functional reach test (FRT); and
12. Subjective visual vertical (SVV).
Evaluations are performed before rehabilitation, after rehabilitation, at discharge, and at 1 month, 3 months, and 6 months after discharge.
Management information
Registered date
| 2025 | Year | 11 | Month | 12 | Day |
Last modified on
| 2025 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068324
