UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015063 |
|---|---|
| Receipt number | R000017526 |
| Scientific Title | Anterior-to-posterior protective capabilities of the Spine Buddy; jockey vest support pad |
| Date of disclosure of the study information | 2014/09/05 |
| Last modified on | 2014/09/05 00:59:30 |
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Basic information
Public title
Anterior-to-posterior protective capabilities of the Spine Buddy; jockey vest support pad
Acronym
Protective jockey vest equipment
Scientific Title
Anterior-to-posterior protective capabilities of the Spine Buddy; jockey vest support pad
Scientific Title:Acronym
Protective jockey vest equipment
Region
| North America |
Condition
Condition
Torso soft tissue injuries
Classification by specialty
| Medicine in general | Chest surgery | Orthopedics |
| Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1)Determine the force attenuating properties of adding an extra support pad to a jockey vest
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Determine how much force an added support pad can decrease compared to a jockey vest alone
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| 45 | years-old | >= |
Gender
Male
Key inclusion criteria
1) the participant was male, 2) the participant had a Body Mass Index (BMI) under 30, 3) between the ages of 18-45 years old, 4) they provided their informed written consent
Key exclusion criteria
1)diagnosis of any cardiovascular, respiratory, neurological, or muscular disorder, 2) presence of pain in their torso or any musculoskeletal injury affecting their torso that they would rate greater than a 3, on a 0 to 10 Numeric Rating Scale (NRS)
Target sample size
14
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | John Ward, DC, MA, MS |
Organization
Texas Chiropractic College
Division name
R
Zip code
Address
5912 Spencer Highway, Pasadena, TX 77505
TEL
2819985704
jward@txchiro.edu
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | John Ward |
Organization
Texas Chiropractic College
Division name
Research
Zip code
Address
5912 Spencer Highway, Pasadena, TX 77505
TEL
2819985704
Homepage URL
jward@txchiro.edu
Sponsor or person
Institute
Texas Chiropractic College
Institute
Department
Personal name
Funding Source
Organization
Spine Buddy company
Organization
Division
Category of Funding Organization
Profit organization
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
| 2014 | Year | 09 | Month | 05 | 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: For the simulated experiment the additional support pad reduced peak force 44.1% more than with the jockey vest alone. In the human experiment the additional support pad reduced peak force 7.3% more than the jockey vest alone (p=0.380).
Conclusion: Preliminarily, the results of this study demonstrate that the addition of the extra support pad to a jockey vest can add to the protective capabilities of the vest in an anterior-to-posterior direction.
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
| 2014 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 08 | Month | 01 | Day |
Other
Other related information
Force was attenuated with the addition of the extra support pad to a standard jockey vest.
Management information
Registered date
| 2014 | Year | 09 | Month | 05 | Day |
Last modified on
| 2014 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017526
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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