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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016901
Receipt No. R000019618
Scientific Title Reliability and validity of Modified Nine Hole Peg Test
Date of disclosure of the study information 2015/03/24
Last modified on 2018/09/27

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Basic information
Public title Reliability and validity of Modified Nine Hole Peg Test
Acronym Reliability and validity of Modified Nine Hole Peg Test
Scientific Title Reliability and validity of Modified Nine Hole Peg Test
Scientific Title:Acronym 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
1st name
Middle name
Last name Narumi Watanabe
Organization Tokyo Bay Rehabilitation Hospital
Division name Division of Occupational therapy
Zip code
Address 4-1-1 Yatsu,Narashino-shi,Chiba
TEL 047-453-9010
Email mymn6222@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Narumi Watanabe
Organization Tokyo Bay Rehabilitation Hospital
Division name Division of Occupational therapy
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 Completed
Date of protocol fixation
2015 Year 03 Month 15 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000019618

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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