UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025310 |
|---|---|
| Receipt number | 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 17:44:11 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
kasuo_saitoh@yahoo.co.jp
Sponsor or person
Institute
Fuchinobe General Hospital
Institute
Department
Personal name
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
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
Value
https://center6.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 |
