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Recruitment status Completed
Unique ID issued by UMIN UMIN000014666
Receipt No. 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

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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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Email 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
Email jward@txchiro.edu

Sponsor
Institute Texas Chiropractic College
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017060


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