UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062578 |
|---|---|
| Receipt number | R000071463 |
| Scientific Title | Test-retest reliability of NIRS-based laterality indices and type classification in convalescent stroke (Phase 0) |
| Date of disclosure of the study information | 2026/08/14 |
| Last modified on | 2026/08/14 13:57:36 |
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Basic information
Public title
A study on the reproducibility of NIRS-based classification indices for stroke upper-limb rehabilitation
Acronym
NIRS-RELY (Phase 0)
Scientific Title
Test-retest reliability of NIRS-based laterality indices and type classification in convalescent stroke (Phase 0)
Scientific Title:Acronym
NIRS-RELY (Phase 0)
Region
| Japan |
Condition
Condition
Stroke (hemorrhagic or ischemic), convalescent phase, upper-limb hemiparesis
Classification by specialty
| Neurology | Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To quantify the test-retest reliability of the continuous laterality indices (Wrist D_raw, Tap Diff) and the derived type labels (Type A/B/C) of an NIRS-based classifier using same-day repeated measurements that exclude true change (rTMS effect and spontaneous recovery), and to judge, by a pre-specified decision rule, whether it is usable for individual-level treatment allocation.
Basic objectives2
Others
Basic objectives -Others
Evaluation of measurement properties (test-retest reliability)
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Test-retest reliability of the continuous indices Wrist D_raw and Tap Diff, expressed as ICC(2,1) with 95%CI; together with SEM_abs, MDC95, and agreement of the type labels (Cohen/Fleiss kappa).
Key secondary outcomes
(1) Reduction of margin = 1.96 x SEM / sqrt(k) with k-averaging (k=1,2,3). (2) Bland-Altman bias and 95% limits of agreement. (3) Within-subject SD, SEM and ICC stratified by severity and task type (tap/grip).
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
Inpatients with stroke (hemorrhagic/ischemic) in a convalescent rehabilitation ward
FMA-UE <= 47 (moderate-to-severe upper-limb paresis)
Meets the functional floor for the NIRS task (can stably perform the affected-hand task for 3 blocks / 180 s on verbal or imitation instruction)
Approximately 14-180 days after onset
Aged 20 years or older
Written informed consent (or by proxy as needed)
Key exclusion criteria
FMA-UE >= 48 (very mild)
Cannot meet the functional floor (severe disturbance of consciousness, severe receptive aphasia, or severe cognitive impairment preventing stable task performance)
Marked involuntary movement precluding stable task performance
Scheduled rTMS or other cortical-excitability-modifying intervention on the day of measurement (the measurement period refers to three consecutive measurements within the same session on a single day; planned rTMS after the measurement day is not an exclusion criterion)
Scalp/skull condition unsuitable for probe attachment
Non-consent
Target sample size
31
Research contact person
Name of lead principal investigator
| 1st name | Takuma |
| Middle name | |
| Last name | Nakamura |
Organization
Kyoto Ohara Memorial Hospital
Division name
Department of Neurology
Zip code
601-1245
Address
334-1 Ohara Todera-cho, Sakyo-ku, Kyoto 601-1245, Japan
TEL
075-744-3121(9992)
nakamuratakuma@kyotoohara-gr.jp
Public contact
Name of contact person
| 1st name | Takuma |
| Middle name | |
| Last name | Nakamura |
Organization
Kyoto Ohara Memorial Hospital
Division name
Department of Neurology
Zip code
601-1245
Address
334-1 Ohara Todera-cho, Sakyo-ku, Kyoto
TEL
075-744-3121
Homepage URL
nakamuratakuma@kyotoohara-gr.jp
Sponsor or person
Institute
Kyoto Ohara Memorial Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
None
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee, Kyoto Ohara Memorial Hospital
Address
334-1 Ohara Todera-cho, Sakyo-ku, Kyoto
Tel
075-744-3121
kobayashinobuyuki@kyotoohara-gr.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
京都大原記念病院（京都府）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 14 | 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 | 08 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 08 | Month | 30 | Day |
Last follow-up date
| 2029 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2029 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2029 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2030 | Year | 01 | Month | 31 | Day |
Other
Other related information
This is a measurement-property (test-retest reliability) study that gates a future treatment-allocation trial. Because repetitions share the same day and montage, the estimated reliability is an upper bound not including donning or between-day variability; real-world reliability may be lower. Reporting follows GRRAS.
The institution formally determined that ethics committee review was not required for this study (non-invasive, non-interventional, and within the scope of routine clinical care; determination date: 19 June 2026). Written informed consent is obtained from participants, and an opt-out procedure is provided when written consent is not feasible.
Management information
Registered date
| 2026 | Year | 08 | Month | 14 | Day |
Last modified on
| 2026 | Year | 08 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071463
