UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061954 |
|---|---|
| Receipt number | R000070891 |
| Scientific Title | A Clinical Observational Study of the Temporal Profile of Muscle Force Generation in Parkinson's Disease and Related Disorders |
| Date of disclosure of the study information | 2026/06/19 |
| Last modified on | 2026/06/17 23:58:53 |
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Basic information
Public title
An Observational Study of Lower Limb Muscle Strength and Changes in Force Generation in Patients With Parkinson's Disease and Related Disorders
Acronym
PDRD Lower Limb Strength Study
Scientific Title
A Clinical Observational Study of the Temporal Profile of Muscle Force Generation in Parkinson's Disease and Related Disorders
Scientific Title:Acronym
MFG PDRD Study
Region
| Japan |
Condition
Condition
Parkinson's Disease, Multiple System Atrophy, Supranuclear Palsy, Progressive
Classification by specialty
| Neurology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to quantitatively evaluate lower limb muscle strength and changes in force generation during repeated muscle contractions in patients with Parkinson's disease and related disorders, and to explore their associations with motor function, disease severity, and clinical characteristics.
Basic objectives2
Others
Basic objectives -Others
Exploration of the associations of lower limb muscle strength and force generation profiles during repeated muscle contractions with clinical measures
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Lower limb muscle strength measured using a hand held dynamometer
Key secondary outcomes
Movement Disorder Society Unified Parkinson's Disease Rating Scale, Mini Balance
evaluation systems test
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 aged 20 years or older at the time of providing informed consent.
2. Patients clinically diagnosed with Parkinson's disease or a related disorder, including multiple system atrophy or progressive supranuclear palsy.
3. Patients with Hoehn and Yahr stage 1-4 disease.
4. Patients who have received a sufficient explanation of the study, fully understood its contents, and provided written informed consent to participate of their own free will.
Key exclusion criteria
1. Patients with comorbidities that may reduce muscle strength, such as orthopedic, psychiatric, or other neurological disorders.
2. Patients in whom muscle strength cannot be reliably assessed because of severe dyskinesia.
3. Patients who are considered unsuitable for participation in the study by the principal investigator for any other reason.
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | SHINYA |
| Middle name | |
| Last name | KOMATSU |
Organization
Juntendo University Urayasu Hospital
Division name
Department of Rehabilitation Medicine
Zip code
2790021
Address
2-1-1 Tomioka, Urayasu-shi, Chiba, Japan
TEL
0473533111
s.komatsu.qt@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | SHINYA |
| Middle name | |
| Last name | KOMATSU |
Organization
Juntendo University Urayasu Hospital
Division name
Department of Rehabilitation Medicine
Zip code
2790021
Address
2-1-1 Tomioka, Urayasu-shi, Chiba, Japan
TEL
0473533111
Homepage URL
s.komatsu.qt@jutendo.ac.jp
Sponsor or person
Institute
Juntendo University Urayasu Hospital
Institute
Department
Personal name
Funding Source
Organization
Juntendo University Urayasu Hospital
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
Juntendo University Urayasu Hospital
Address
2-1-1 Tomioka, Urayasu-shi, Chiba, Japan
Tel
0473533111
s.komatsu.qt@juntendo.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
jRCT1030260227
Org. issuing International ID_1
Japan Registry of Clinical Trials
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
順天堂大学医学部附属浦安病院
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 19 | 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
| 2025 | Year | 05 | Month | 10 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 03 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The aim of this study is to evaluate isometric muscle strength, the process of maximal force generation during repeated measurements, and electromyographic data in hospitalized patients with Parkinson's disease and related disorders; to investigate how these parameters are associated with motor symptoms that are less responsive to pharmacological treatment, such as gait impairment and postural instability and ultimately to contribute to the development of more effective rehabilitation strategies.
Management information
Registered date
| 2026 | Year | 06 | Month | 17 | Day |
Last modified on
| 2026 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070891
