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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025310
Receipt No. R000029108
Scientific Title Strength required for opening plastic bottles in individuals with distal radius fracture
Date of disclosure of the study information 2016/12/17
Last modified on 2016/12/17

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Basic information
Public title Strength required for opening plastic bottles in individuals with distal radius fracture
Acronym Strength required for opening plastic bottles
Scientific Title Strength required for opening plastic bottles in individuals with distal radius fracture
Scientific Title:Acronym Strength required for opening plastic bottles
Region
Japan

Condition
Condition Distal radius fractur
Classification by specialty
Orthopedics Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In this study targeting radius distal fractures patients, we examined cut off values the muscle strength.
Basic objectives2 Others
Basic objectives -Others We examined cut off values the muscle strength.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Receiver operating characteristic curve (ROC curve) sensitivity,specificity,area under the vurve(AUO)
Key secondary outcomes Grip strength, Pinch strength, trquue value

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Includion criteria were distal radius fracture (dominant hand right side) and conservative treatment.
Key exclusion criteria Exclusion criteria included open lesions,operative treatment.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuo Saito
Organization Fuchinobe General Hospital
Division name The department of Rehabilitation Center
Zip code
Address 3-2-8 Fuchinobe, Chuo-ku, Sagamihara, Kanagawa
TEL 042-754-2222
Email kasuo_saitoh@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuo Saito
Organization Fuchinobe General Hospital
Division name The department of Rehabilitation Center
Zip code
Address 3-2-8 Fuchinobe, Chuo-ku, Sagamihara, Kanagawa
TEL 042-754-2222
Homepage URL
Email kasuo_saitoh@yahoo.co.jp

Sponsor
Institute Fuchinobe General Hospital
Institute
Department

Funding Source
Organization Fuchinobe General Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information
2016 Year 12 Month 17 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
The muscle strength required to estimate the torque necessary for opening a plastic bottle was grip strength and pinch strength of the right hand. Grip strength of the right hand (OR 1.50; 1.26-1.91, p=0.001), pinch strength of the right hand (OR 1.12; 0.88-1.29, p=0.001), and torque value (OR 1.74; 1.04-2.91, p=0.001) were identified using logistic regression as predictive factors for the opening of a plastic bottle. 
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
2012 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 11 Month 01 Day
Last follow-up date
2015 Year 11 Month 30 Day
Date of closure to data entry
2015 Year 11 Month 30 Day
Date trial data considered complete
2015 Year 11 Month 30 Day
Date analysis concluded
2016 Year 01 Month 28 Day

Other
Other related information The ROC curve revealed the cutoff values for predicting this possibility in grip strength of the right hand (20.5 kg; sensitivity 86.6; specificity 94.4; AUC 96.4; p=0.001), pinch strength of the right hand (4.5 kg; sensitivity 91.1; specificity 94.4; AUC 96.3; p=0.001), and torque value (95 N-cm; sensitivity 96.4; specificity 83.3; AUC 98.7; p=0.001).

Management information
Registered date
2016 Year 12 Month 17 Day
Last modified on
2016 Year 12 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029108

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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