UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016901
Receipt number 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 19:07:38

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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 or person

Institute

Tokyo Bay Rehabilitation Hospital

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

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

Value
https://center6.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