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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||
Condition | First-ever stroke patients | |
Classification by specialty |
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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 | |
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Interventions/Control_9 | |
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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. |
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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. |
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Target sample size | 120 |
Research contact person | |||||||
Name of lead principal investigator |
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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 | ||||||
mymn6222@gmail.com |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 | |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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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 |
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Last modified on |
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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 |