UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043079 |
|---|---|
| Receipt number | R000049179 |
| Scientific Title | Effects of ankle malalignment on gait characteristics and locomotor mechanisms |
| Date of disclosure of the study information | 2021/01/21 |
| Last modified on | 2021/01/21 17:00:53 |
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Basic information
Public title
Investigation of the effects on gait and locomotion of people with unstable ankles
Acronym
Effects of the ankle on gait and locomotion
Scientific Title
Effects of ankle malalignment on gait characteristics and locomotor mechanisms
Scientific Title:Acronym
Effects on gait and locomotion in ankle malalignment
Region
| Japan |
Condition
Condition
Ankle joint misalignment
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Since those with chronic back pain, knee pain, and hip pain tended to have problems with ankle alignment in general, we used a gait survey to verify the degree of influence on the human body when ankle alignment is problematic, and to confirm the effectiveness of adjusting ankle alignment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The effective area at the time of ground contact during walking in the truss mechanism and windlass mechanism, ankle joint dorsiflexion, walking speed, and stride length during a 5 m walk of a person with ankle malalignment are measured and evaluated before and after ankle alignment adjustment, respectively. The evaluation and measurement days will be conducted during one day each. The period until the end of the test shall be one month.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Maneuver |
Interventions/Control_1
Patients with ankle malalignment were asked to walk 5 m without adjustment, and after walking, they were asked to make heel contact, and ankle joint dorsiflexion, stride length, and 5 m walking time were measured.
Interventions/Control_2
Those with ankle malalignment were asked to walk 5 m after the alignment was adjusted, and to measure ankle dorsiflexion, stride length, and 5 m walking time after walking with heel contact.
Interventions/Control_3
To measure the effective range of the truss mechanism and windlass mechanism on the printed area by applying ink to the sole of a person with ankle joint malalignment and anterior lateral deviation of the talus (oversupination), and to compare the results with those of a person with normal gait (0 degree forefoot foot angle).
Interventions/Control_4
To measure the effective range of the truss mechanism and windlass mechanism on the printed area by applying ink to the sole of a person with ankle joint malalignment and anterior lateral deviation of the talus (overpronation), and to compare the results with those of a person with normal gait (0 degree forefoot foot angle).
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 15 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Persons with ankle joint malalignment
Key exclusion criteria
Gender, height and weight differences, and other underlying diseases will not be taken into account, and the focus will be on ankle malalignment. We will ethically exclude cases where there is a compliance problem, where the purpose of the study is explained to the subjects and they fully understand the study, but there are subjects who do not understand the study, or who are judged to be unsuitable for the study due to their physical condition.
Target sample size
59
Research contact person
Name of lead principal investigator
| 1st name | Noriomi |
| Middle name | |
| Last name | Tsunoda |
Organization
TrueTreatGroup Inc.
Division name
True Treat GINZA
Zip code
104-0061
Address
3-11-19 Ginza,Chu-ou ku,Tokyo,Japan
TEL
0362643372
aoisekkotsuin@hotmail.co.jp
Public contact
Name of contact person
| 1st name | Noriomi |
| Middle name | |
| Last name | Tsunoda |
Organization
TrueTreatGroup Inc.
Division name
Representative Director
Zip code
104-0061
Address
3-11-19 Ginza,Chu-ou ku,Tokyo,Japan
TEL
0362643372
Homepage URL
aoisekkotsuin@hotmail.co.jp
Sponsor or person
Institute
True Treat Group INC.
Institute
Department
Personal name
Funding Source
Organization
N/A
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
N/A
Address
N/A
Tel
N/A
N/A
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
TrueTreatGINZA(東京都)
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 01 | Month | 21 | 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
59
Results
Alignment normal (0 forefoot angle) (in square centimeters)
Forefoot 48 hindfoot 40.4
Anterior lateral deviation of talus (forefoot abduction external rotation 10)
Forefoot 39.9, hindfoot 43.2
Anterior lateral rotation deviation of talus (forefoot adduction internal rotation 5)
Forefoot 50.1 hindfoot 36.9
Ankle misalignment
(Before adjustment)
Stride length 44.8cm, dorsiflexion 8.08, walking time 4.81
(After adjustment)
Stride length 49.7 cm, dorsiflexion 11.64, walking time 4.23
Results date posted
| 2021 | Year | 01 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Windlass and truss mechanism survey
9 males, height 169-181cm, weight 60-100
Age 31-55
Insufficient Alignment Gait Survey
40 subjects of 25 males and 25 females each
Average height 163.46 cm, Average weight 62.38 kg
Average age 49.98 years
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 04 | Month | 19 | Day |
Date of IRB
| 1977 | Year | 01 | Month | 01 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 19 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 01 | Month | 21 | Day |
Last modified on
| 2021 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049179
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