UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059921 |
|---|---|
| Receipt number | R000068070 |
| Scientific Title | Relationship Between Stretch Reflex Measured Using a Pronation Supination Training Device and Spasticity and Upper Limb Function in Stroke Patients |
| Date of disclosure of the study information | 2025/11/29 |
| Last modified on | 2025/11/29 00:02:55 |
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Basic information
Public title
A Study Investigating the Relationship Between Upper Limb Function in Stroke Patients and Spasticity and Stretch Reflexes
Acronym
A Study Investigating the Relationship Between Upper Limb Function, Spasticity, and Stretch Reflexes
Scientific Title
Relationship Between Stretch Reflex Measured Using a Pronation Supination Training Device and Spasticity and Upper Limb Function in Stroke Patients
Scientific Title:Acronym
Relationship Between Stretch Reflex Measured Using a Forearm Pronation Supination Training Device and Upper Limb Function and Spasticity in Stroke Patients
Region
| Japan |
Condition
Condition
central nervous disiease
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
o clarify the relationship between the amplitude of the stretch reflex in the pronator teres muscle and clinically assessed spasticity.
Basic objectives2
Others
Basic objectives -Others
Relationship
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amplitude of the stretch reflex in the pronator teres muscle
Key secondary outcomes
FuglMeyer Assessment Upper Extremity
Box and Block Test
Modified Ashworth Scale
Superficial sensation
Deep sensation
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment | Other |
Interventions/Control_1
Measurement using the forearm pronation-supination device
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Stroke patients aged 18 years or older
Key exclusion criteria
Individuals with higher brain dysfunction or cognitive impairment who have difficulty following test instructions
Individuals with pain in the paretic upper limb
Individuals who have difficulty maintaining a sitting position
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Koya |
| Middle name | |
| Last name | Fujimoto |
Organization
kajiki onsen hpsiptal
Division name
Rehabilitation Center
Zip code
8995241
Address
4714 Kida, Kajiki-cho, Aira City, Kagoshima Prefecture
TEL
0995620001
koya.0416.fjmt@gmail.com
Public contact
Name of contact person
| 1st name | Koya |
| Middle name | |
| Last name | Fujimoto |
Organization
kajiki onsen hospital
Division name
Rehabilitation room
Zip code
8905241
Address
4714 Kida, Kajiki-cho, Aira City, Kagoshima Prefecture
TEL
0995620001
Homepage URL
koya.0416.fjmt@gmail.com
Sponsor or person
Institute
kajiki onsen hospital
Institute
Department
Personal name
Funding Source
Organization
kajikionsen hosptal
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
Kajiki onsen hosptal
Address
4714 Kida, Kajiki-cho, Aira City, Kagoshima Prefecture
Tel
0995620001
koya.0416.fjmt@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
| 2025 | Year | 11 | Month | 29 | 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
| 2021 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 25 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2026 | 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
| 2025 | Year | 11 | Month | 29 | Day |
Last modified on
| 2025 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068070
