UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060753 |
|---|---|
| Receipt number | R000069521 |
| Scientific Title | Rehabilitation therapy for lower limb spasticity in subacute sclerosing panencephalitis: A single-case experimental design study |
| Date of disclosure of the study information | 2026/02/26 |
| Last modified on | 2026/02/26 13:14:00 |
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Basic information
Public title
Rehabilitation therapy for lower limb spasticity in subacute sclerosing panencephalitis: A single-case experimental design study
Acronym
Rehabilitation therapy for lower limb spasticity in subacute sclerosing panencephalitis: A single-case experimental design study
Scientific Title
Rehabilitation therapy for lower limb spasticity in subacute sclerosing panencephalitis: A single-case experimental design study
Scientific Title:Acronym
Rehabilitation therapy for lower limb spasticity in subacute sclerosing panencephalitis: A single-case experimental design study
Region
| Japan |
Condition
Condition
Lower limb spasticity, Subacute sclerosing panencephalitis (SSPE)
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Subacute sclerosing panencephalitis (SSPE) is a rare, fatal disease, yet evidence for rehabilitation in long-term survivors is lacking. This study aims to evaluate the efficacy of rehabilitation for lower limb spasticity in these patients. The intervention involves botulinum toxin therapy to assess initial improvement, followed by a home-based vibration stimulation program to confirm its additional effects on spasticity suppression.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Inter-Knee Distance
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
n-of-1
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Botulinum therapy
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
| 60 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
A patient with subacute sclerosing panencephalitis presenting with gait disturbance due to lower limb spasticity
Key exclusion criteria
Those unable to communicate, those in poor overall health, and others deemed unsuitable by a physician
Target sample size
1
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Ueno |
Organization
Ogura Hospital
Division name
rehabilitation
Zip code
893-0023
Address
27-22 Kasano-hara-cho, Kanoya City, Kagoshima Prefecture
TEL
0994447171
muruto.ruiner@gmail.com
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Ueno |
Organization
Ogura Hospital
Division name
rehabilitation
Zip code
893-0023
Address
27-22 Kasano-hara-cho, Kanoya City, Kagoshima Prefecture
TEL
0994447171
Homepage URL
muruto_ruiner@hotmail.com
Sponsor or person
Institute
Ogura Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
Ogura Hospital
Address
27-22 Kasano-hara-cho, Kanoya City, Kagoshima Prefecture
Tel
0994447171
k0720622@kadai.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
| 2026 | Year | 02 | Month | 26 | 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
| 2026 | Year | 02 | Month | 13 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 25 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 26 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 01 | 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 | 02 | Month | 26 | Day |
Last modified on
| 2026 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069521
