UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060403 |
|---|---|
| Receipt number | R000069101 |
| Scientific Title | Effects of Ischemic Numbness Induction and Therapeutic Interventions on Sensory and Muscular Functions and Peripheral Blood Parameters in Healthy Adults |
| Date of disclosure of the study information | 2026/01/19 |
| Last modified on | 2026/01/19 17:51:52 |
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Basic information
Public title
Effects of Ischemic Numbness Induction and Therapeutic Interventions on Sensory and Muscular Functions and Peripheral Blood Parameters in Healthy Adults
Acronym
Effects of Ischemic Numbness Induction and Therapeutic Interventions on Sensory and Muscular Functions and Peripheral Blood Parameters in Healthy Adults
Scientific Title
Effects of Ischemic Numbness Induction and Therapeutic Interventions on Sensory and Muscular Functions and Peripheral Blood Parameters in Healthy Adults
Scientific Title:Acronym
Effects of Ischemic Numbness Induction and Therapeutic Interventions on Sensory and Muscular Functions and Peripheral Blood Parameters in Healthy Adults
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Numbness is a common symptom in both daily life and clinical practice, however, the physiological impact of transient numbness on sensory motor functions and peripheral blood markers in healthy individuals remains poorly understood. In this study, we will safely induce temporary numbness in healthy adults to analyze body responses in detail. Additionally, we will compare the effectiveness of three interventions stretching, light resistance training, and massage on the recovery process. Our objective is to establish a basic dataset that will contribute to more effective rehabilitation methods for managing numbness.
Basic objectives2
Others
Basic objectives -Others
N/A
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sensory function assessment, Muscle strength measurement (Handgrip strength), Blood tests (Capillary self-sampling)
Key secondary outcomes
Numbness intensity (Questionnaire)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Static stretching
Interventions/Control_2
Light intensity resistance training
Interventions/Control_3
Light massage
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
| 23 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adults (aged 18 and older) who understand the study procedures and provide informed consent.
Key exclusion criteria
History of neurological, cardiovascular, or metabolic diseases (e.g., diabetes).
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Toshiharu |
| Middle name | |
| Last name | Yasaka |
Organization
Niigata University of Health and Welfare
Division name
Department of Physical Therapy
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, Niigata-shi, Niigata, JAPAN
TEL
025-250-1645
yasaka@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Toshiharu |
| Middle name | |
| Last name | Yasaka |
Organization
Niigata University of Health and Welfare
Division name
Department of Physical Therapy
Zip code
950-3198
Address
1398 Shimami-cho, Kita-ku, Niigata-shi, Niigata, JAPAN
TEL
025-250-1645
Homepage URL
yasaka@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Niigata University of Health and Welfare
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
Niigata University of Health and Welfare
Address
Niigata University of Health and Welfare
Tel
025-257-4455
rinri@nuhw.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 01 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 02 | Month | 01 | 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
Management information
Registered date
| 2026 | Year | 01 | Month | 19 | Day |
Last modified on
| 2026 | Year | 01 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069101
