UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014662 |
|---|---|
| Receipt number | 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 13:29:47 |
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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
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
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
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/
jward@txchiro.edu
Sponsor or person
Institute
Texas Chiropractic College
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017055
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
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