UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025859 |
|---|---|
| Receipt number | R000029733 |
| Scientific Title | The association between toe function and foot morphology, and biomechanics of the knee during walking |
| Date of disclosure of the study information | 2017/02/01 |
| Last modified on | 2022/08/01 10:16:28 |
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Basic information
Public title
The association between toe function and foot morphology, and biomechanics of the knee during walking
Acronym
The association between toe function and foot morphology, and biomechanics of the knee during walking
Scientific Title
The association between toe function and foot morphology, and biomechanics of the knee during walking
Scientific Title:Acronym
The association between toe function and foot morphology, and biomechanics of the knee during walking
Region
| Japan |
Condition
Condition
Osterarthritis of the knee
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the association between toe grip strength and foot morphology, and biomechanics of the knee during walking
Basic objectives2
Others
Basic objectives -Others
Biomechanical study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Accerelation of the knee during walking
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
self training about strengthening exercise of the toe flexor muscle
Interventions/Control_2
control
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Community-dwelling people
patients with OA of the knee
Key exclusion criteria
people with neurological deficit of the lower extremity
people with history of the surgery or severe injury in their lower extremity
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Uritani |
Organization
Kio University
Division name
Department of Physical Therapy, Faculty of Health Science
Zip code
6350832
Address
4-2-2 Umaminaka Koryocho Kitakatsuragigun Nara
TEL
0745541601
d.uritani@kio.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Nakayama |
Organization
Kio University
Division name
Department of general affairs
Zip code
6350832
Address
4-2-2 Umaminaka Koryocho Kitakatsuragigun Nara
TEL
0745541601
Homepage URL
h.nakayama@kio.ac.jp
Sponsor or person
Institute
Kio University
Institute
Department
Personal name
Funding Source
Organization
Kio University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kio University
Address
4-2-2 Umaminaka Koryocho Kitakatsuragigun Nara
Tel
0745541601
soumu@kio.ac.jp
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
| 2017 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
https://bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-022-05624-y
Publication of results
Published
Result
URL related to results and publications
https://bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-022-05624-y
Number of participants that the trial has enrolled
36
Results
Walking Staheli Arch Index (SAI) and first peak medial tibiofemoral contact force (CF) in control participants (r = -0.505, p = 0.039). SAI was also significantly positively correlated with first peak medial tibiofemoral CF in patients with knee OA (r = 0.482, p = 0.042). This study indicates that people with knee OA and flatfoot have excessive first medial tibiofemoral CF during walking.
Results date posted
| 2022 | Year | 08 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
For Knee OA group, Age > 45 years and radiographic changes with Kellgren-Lawrence (KL) grade of 2 or higher in the medial tibiofemoral compartment.
For control group, the inclusion criteria were as follows: age > 45 years, walking independently without any ambulatory assistive device, and no pain in the knee joint, and we excluded those with any previous surgical treatment for the lower limbs or trunk or known neuromuscular or musculoskeletal pathologies.
Participant flow
Outpatients with Knee OA diagnosed by their treating physician in orthopedics at a Hospital and healthy adults from participants in a health promotion project conducted by a town, Nara, Japan, and from the staff members of the Hospital.
Adverse events
None
Outcome measures
tibiofemoral contact force
Foot Posture Index
Staheli Arch Index
hallux valgus angle
calcaneus inverted angle relative to the floor as a static rearfoot posture
navicular height
toe grip strength
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 14 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 26 | Day |
Last modified on
| 2022 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029733
