UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016936 |
|---|---|
| Receipt number | R000019662 |
| Scientific Title | Crural index influence on parameters of female running gait. |
| Date of disclosure of the study information | 2015/03/28 |
| Last modified on | 2015/03/27 13:14:52 |
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Basic information
Public title
Crural index influence on parameters of female running gait.
Acronym
Lower limb length and female running gait
Scientific Title
Crural index influence on parameters of female running gait.
Scientific Title:Acronym
Lower limb length and female running gait
Region
| North America |
Condition
Condition
gait
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of the study was to determine if the crural index impacted female running gait attributes in a predictable way.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Analysis of functional range of motion of lower limb joints, step length, and stride length.
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
| 17 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Female
Key inclusion criteria
1) Body Mass Index (BMI) under 30
2) female 17-40 years of age
3) provide written informed consent
4) report no contraindication to running
5) answer "no" to all sections on the Physical
Activity Readiness Questionnaire (PAR-Q)
6) capable of running 7 mph for a few minutes
7) participant must report regular (2x wk)
running in the previous 2 months
Key exclusion criteria
1) any surgery in the past year
2) any broken bones in the past year
3) reported neurologic conditions (multiple
sclerosis, myasthenia gravis, etc.)
4) reported cardiopulmonary conditions (asthma,
congestive heart failure, emphysema, etc.)
5) pregnancy
6) rheumatoid arthritis
7) Down's syndrome
8) known anemia
9) kidney pathology
10) daily pain rated greater than 3 on 1-10 a Numeric Rating Scale (NRS)
11) lower limb pathologies (Morton's neuroma,plantar fascitis, shin splints, etc.)
Target sample size
20
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
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
Texas Chiropractic College
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
| 2015 | Year | 03 | 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
The results demonstrated that there was not statistically significant differences for functional hip range of motion (p=0.960), knee range of motion (p=0.943), ankle range of motion (p=0.419), stance phase in seconds (p=0.481), step length (p=0.804), or stride length (p=0.965) between the two groups analyzed.
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
Date of closure to data entry
Date trial data considered complete
| 2014 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 09 | Month | 01 | Day |
Other
Other related information
Preliminarily, the results from this study demonstrate that crural index has no impact on lower limb joint functional range of motion, step length, stride length, or similar gait parameters for female participants running at a static sub-maximal velocity.
Management information
Registered date
| 2015 | Year | 03 | Month | 27 | Day |
Last modified on
| 2015 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019662
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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