UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061223 |
|---|---|
| Receipt number | R000070011 |
| Scientific Title | Japanese study therapeutic exercise for progressive supranuclear palsy |
| Date of disclosure of the study information | 2026/04/10 |
| Last modified on | 2026/04/10 13:07:16 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Japanese study therapeutic exercise for progressive supranuclear palsy
Acronym
J-STEP
Scientific Title
Japanese study therapeutic exercise for progressive supranuclear palsy
Scientific Title:Acronym
J-STEP
Region
| Japan |
Condition
Condition
Progressive supranuclear palsy
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary objective of this study is to evaluate the efficacy of a 2-week short-term intensive inpatient rehabilitation program in reducing the frequency of falls among patients with progressive supranuclear palsy (PSP).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Number of falls
Key secondary outcomes
Pre-observation period and post-observation period
Number of falls and fall-related injuries
During the intervention period
BBS, PSPRS,10m walk speed, Backward walking , TUG, FIM. The PSP QoL, handgrip strength, knee extension strength
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
The intervention involves 10 daily sessions of a combined exercise program (80 min/day), including 40 minutes of PT and 40 minutes of OT.
Interventions/Control_2
Patients will continue their usual home life while maintaining the medical and nursing care insurance services they were receiving prior to the start of the study.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who meet the criteria for "probable" PSP-Richardson syndrome according to the Movement Disorder Society Evidence-Based Diagnosis of PSP.
Key exclusion criteria
1.Patients unable to walk 10 meters independently even with the use of a walking aid.
2.Patients with a history of lower limb fracture.
3.Patients with comorbidities or complications that may affect the implementation of this study.
4.Patients with a Mini-Mental State Examination (MMSE) score of 20 or less.
5.Patients who cannot complete the primary and secondary outcome measures.
6.Patients without a caregiver who can monitor the number of falls.
7.Patients deemed inappropriate for study participation by their attending physician.
8.Patients with no history of falls within the past month.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yasuyuki |
| Middle name | |
| Last name | Takamatsu |
Organization
Chubu University
Division name
Department of Physical Therapy, College of Life and Health Sciences
Zip code
487-0027
Address
1200 Matsumoto-cho, Kasugai-shi, Aichi
TEL
0568-51-1111
y_takamatsu@fsc.chubu.ac.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Sawada |
Organization
Reiwa Health Sciences University
Division name
Department of Physical Therapy, Faculty of Rehabilitation
Zip code
811-0213
Address
2-1-12 Wajirogaoka, Higashi-ku, Fukuoka-shi, Fukuoka
TEL
092-607-6701
Homepage URL
m.sawada@kyoju.ac.jp
Sponsor or person
Institute
National Hospital Organization, Higashinagoya National Hospital
Institute
Department
Personal name
Funding Source
Organization
Health and Labour Sciences Research Grant
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Hospital Organization Nishitaga National Hospital,National Hospital Organization Matsue Medical Center,Hokkaido University,Reiwa Health Sciences University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Chubu University
Address
1200 Matsumoto cho, Kasugai-shi, Aichi
Tel
0568-51-1111
y_takamatsu@fsc.chubu.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
国立病院機構東名古屋病院(愛知県)、国立病院機構仙台西多賀病院(宮城県)、国立病院機構松江医療センター(島根県)
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 10 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 11 | Month | 18 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 18 | Day |
Anticipated trial start date
| 2026 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | 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
| 2026 | Year | 04 | Month | 10 | Day |
Last modified on
| 2026 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070011
