UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014666 |
|---|---|
| Receipt number | R000017060 |
| Scientific Title | Spine Buddy supportive pad impact on single-leg static balance and jogging gait of individuals wearing a military backpack. |
| Date of disclosure of the study information | 2014/07/28 |
| Last modified on | 2014/07/27 22:02:47 |
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Basic information
Public title
Spine Buddy supportive pad impact on single-leg static balance
and jogging gait of individuals wearing a military backpack.
Acronym
Supportive pad impact on military backpack use
Scientific Title
Spine Buddy supportive pad impact on single-leg static balance
and jogging gait of individuals wearing a military backpack.
Scientific Title:Acronym
Supportive pad impact on military backpack use
Region
| North America |
Condition
Condition
ergonomics
Classification by specialty
| Medicine in general | Orthopedics | Rehabilitation medicine |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1)Determine if wearing the Spine Buddy pad underneath a military backpack impacts running gait. 2)Determine if wearing the Spine Buddy pad impacts balance.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measure step length, stride length, approximate entropy, active range of motion changes, static balance, and other gait-related variables.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Randomized
Randomization unit
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Spine Buddy pad placed underneath a military backpack.
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
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
between the ages of 18-50 years old, answering no to all exercise contraindication sections on a Physical Activity Readiness-Questionnaire (PAR-Q), they did not engage in strenuous exercise the day of the study, and they provided their informed written consent.
Key exclusion criteria
diagnosis of any lumbar, sacral, hip, or lower limb pathology that would prevent them from jogging, severe neurological conditions which would impact gait, history of alcohol abuse, any health condition that would impair their ability to jog up to 5 mph, visual impairment that would render jogging on a treadmill dangerous for them, hypertonia, use of a cane or similar assistive device, taking medications that alter motor function, botulinum injection in their lower limb muscles within the past six months, presence of severe pain in their lower limbs that they would rate greater than a 3 on a 0 to 10 Numeric Rating Scale, vertigo or history of falls within the past 60 days, or any prior bone or muscle-related surgeries.
Target sample size
40
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
Research
Zip code
Address
5912 Spencer Highway, Pasadena, TX 77505
TEL
281-998-5704
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
281-998-5704
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 | 07 | Month | 28 | 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
| 2013 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 07 | Month | 27 | Day |
Last modified on
| 2014 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017060
