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Recruitment status Completed
Unique ID issued by UMIN UMIN000014662
Receipt No. R000017055
Scientific Title The impact of placing Rocktape over the anterior lower limbs on improving runner gait kinematics in a fatigued state
Date of disclosure of the study information 2014/07/27
Last modified on 2014/07/27

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Basic information
Public title The impact of placing Rocktape over the anterior lower limbs on improving runner gait kinematics in a fatigued state
Acronym Rocktape impact on fatigue
Scientific Title The impact of placing Rocktape over the anterior lower limbs on improving runner gait kinematics in a fatigued state
Scientific Title:Acronym Rocktape impact on fatigue
Region
North America

Condition
Condition Runner fatigue
Classification by specialty
Medicine in general Orthopedics Rehabilitation medicine
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 1)Determine how Rocktape placed over the anterior thighs impacts runner gait in a fatigued state.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Measure step length, stride length, approximate entropy, and other gait-related variables.
Key secondary outcomes na

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 Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Rocktape placed over the anterior thighs.
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
45 years-old >=
Gender Male and Female
Key inclusion criteria 1) they reported no contraindication to running or cycling, 2) between the ages of 18-45, 3) answer "no" to all exercise contraindication sections on a Physical Activity Readiness Questionnaire (PAR-Q), 4)they provided their informed written consent.
Key exclusion criteria 1) any surgery in the past year, 2) any broken bones in the past year, 3) reported neurologic conditions, 4) reported cardiopulmonary conditions, 5)pregnancy, 6)rheumatoid arthritis, 7)Down's syndrome, 8)known anemia, 9)kidney pathology, 10)daily pain rated greater than a 3 on a 1-10 numeric rating scale.
Target sample size 42

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 http://www.txchiro.edu/
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 Rocktape company
Organization
Division
Category of Funding Organization Non profit foundation
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 27 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: After the fatigue protocol, the no-tape group demonstrated a significant decrease in step length (p=0.041) and stride length (p=0.043).  The kinesiology tape group did not demonstrate a significant decline in these gait parameters.  
Conclusions: Preliminarily, placing kinesiology tape over the anterior lower limbs may have some ability to preserve runner step length and stride length in a fatigued state.
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 01 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 06 Month 01 Day
Last follow-up date
2013 Year 08 Month 01 Day
Date of closure to data entry
2013 Year 08 Month 01 Day
Date trial data considered complete
2013 Year 09 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=R000017055


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