UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Reliability and validity of Modified Nine Hole Peg Test
Title of the study (Brief title)	Reliability and validity of Modified Nine Hole Peg Test
Region	Japan

Condition
Condition	First-ever stroke patients
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of the study is to examine reliability and validity of Modified Nine Hole Peg Test.
Basic objectives2	Others
Basic objectives -Others	A study of reliability and validity
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Modified Nine Hole Peg Test
Key secondary outcomes	Nine Hole Peg Test Cognitive function tests

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	(Healthy sybjects) 1.Healthy adults. 2.Consent to participate in this study. (Patients with stroke) 1.More than 1 month after the onset of first-ever stroke. 2.Able to sit without assistance 3.Able to understand the instruction of the tasks. 4.Consent to participate in this study.
Key exclusion criteria	(Healthy sybjects) 1.Pain that affects the task performance. 2.Neuromusculoskeletal conditions that affect the task performance. 3.Visual deficits. 4.Cognitive deficits. (Patients with stroke) 1.Pain that affects the task performance. 2.Other central nervous system diseases other than stroke. 3.Neuromusculoskeletal conditions that affect the task performance. 4.Visual deficits. 5.Subarachnoid hemorrhage, lesion in the cerebellum, multiple brain lesion.
Target sample size	120

Research contact person
Name of lead principal investigator	Narumi Watanabe
Organization	Tokyo Bay Rehabilitation Hospital
Division name	Division of Occupational therapy
Address	4-1-1 Yatsu,Narashino-shi,Chiba
TEL	047-453-9010
Email	mymn6222@gmail.com

Public contact
Name of contact person	Narumi Watanabe
Organization	Tokyo Bay Rehabilitation Hospital
Division name	Division of Occupational therapy
Address	4-1-1 Yatsu,Narashino-shi,Chiba
TEL	047-453-9010
Homepage URL
Email	mymn6222@gmail.com

Sponsor
Institute	Tokyo Bay Rehabilitation Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Department of Rehabilitation Medicine, Keio University School of Medicine
Name of secondary funｄer(s)

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	東京湾岸リハビリテーション病院 Tokyo Bay Rehabilitation Hospital

Other administrative information
Date of disclosure of the study information	2015 Year 03 Month 24 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 03 Month 15 Day
Anticipated trial start date	2015 Year 03 Month 24 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Test-retest reliability of the Modified Nine Hole Peg Test is examined with intraclass correlation coefficients (1,1). Absolute reliability is examined with Bland Altman analysis and minimal detectable change. Concurrent validity of the Modified Nine Hole Peg Test with the Nine Hole Peg Test is examined with Pearson product-moment correlation coefficients. We examine whether the differences in time required between the Modified Nine Hole Peg Test and the Nine Hole Peg Test are related to the cognitive deficits or not.

Management information
Registered date	2015 Year 03 Month 24 Day
Last modified on	2018 Year 09 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019618