UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000056852
Receipt number R000064940
Scientific Title Development of a Japanese version of the Rivermead Assessment of Somatosensory Performance (RASP) for stroke patients
Date of disclosure of the study information 2025/01/29
Last modified on 2025/08/01 08:36:38

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Basic information

Public title

Development of a Japanese version of the Rivermead Assessment of Somatosensory Performance (RASP) for stroke patients

Acronym

Development of a Japanese version of RASP

Scientific Title

Development of a Japanese version of the Rivermead Assessment of Somatosensory Performance (RASP) for stroke patients

Scientific Title:Acronym

Development of a Japanese version of RASP

Region

Japan


Condition

Condition

Stroke

Classification by specialty

Neurology Rehabilitation medicine Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To develop the reliability and validity of the Japanese version of the Rivermead Assessment of Somatosensory Performance(RASP-J)

Basic objectives2

Others

Basic objectives -Others

To examine the reliability and validity of the Japanese version of the Rivermead Assessment of Somatosensory Performance(RASP-J)

Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

the Japanese version of the Rivermead Assessment of Somatosensory Performance

Key secondary outcomes



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

90 years-old >=

Gender

Male and Female

Key inclusion criteria

the appearance of hemiparesis and somatosensory disturbance after stroke

Key exclusion criteria

(1)clear signs of dementia; (2) aphasia or mental disorders that may lead to failures in the examination; (3) excessive pain in any joint that might limit participation; and (4) serious uncontrolled medical conditions.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Kazumi
Middle name
Last name Hirayama

Organization

Yamagata Prefectural University of Health Sciences

Division name

Graduate School of Health Sciences

Zip code

990-2212

Address

260, Kamiyanagi, Yamagata, Yamagata

TEL

023-686-6611

Email

g.khirayama@yachts.ac.jp


Public contact

Name of contact person

1st name Keisuke
Middle name
Last name Hanada

Organization

Shijonawate Gakuen University

Division name

Faculty of Rehabilitation

Zip code

574-0011

Address

5-11-10, Hojo, Daito, Osaka

TEL

072-863-5043

Homepage URL


Email

k-hanada@un.shijonawate-gakuen.ac.jp


Sponsor or person

Institute

Yamagata Prefectural Univeresity of Health Sciences

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

Yamagata Prefectural University of Health Sciences Ethics Committee

Address

260, Kamiyanagi, Yamagata, Yamagata

Tel

023-686-6611

Email

g.khirayama@yachts.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

2025 Year 01 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

30

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

No longer recruiting

Date of protocol fixation

2020 Year 05 Month 14 Day

Date of IRB

2020 Year 06 Month 05 Day

Anticipated trial start date

2022 Year 10 Month 01 Day

Last follow-up date

2025 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Translation of RASP-J has been completed. Data collection is currently underway.


Management information

Registered date

2025 Year 01 Month 29 Day

Last modified on

2025 Year 08 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064940