UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049146 |
|---|---|
| Receipt number | R000055983 |
| Scientific Title | Effect of shoe heel stiffness in patients with hemophilic ankle arthropathy. |
| Date of disclosure of the study information | 2022/12/19 |
| Last modified on | 2024/04/19 13:49:58 |
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Basic information
Public title
Effect of shoe heel stiffness in patientswith hemophilic ankle arthropathy.
Acronym
Effect of shoe heel stiffness in patients with hemophilic ankle arthropathy.
Scientific Title
Effect of shoe heel stiffness in patients with hemophilic ankle arthropathy.
Scientific Title:Acronym
Effect of shoe heel stiffness in patients with hemophilic ankle arthropathy.
Region
| Japan |
Condition
Condition
hemophilia
Classification by specialty
| Hematology and clinical oncology | Infectious disease | Orthopedics |
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Walking using 3 types of shoes with different hardness of piled up shoes (heels) and 2 types of sole braces with different hardness. We will use NRS and VAS to examine how it is affected.
Basic objectives2
Others
Basic objectives -Others
It has been reported that the SACH foot has a function to compensate for plantar flexion, so if the cushioning property works properly, compensation for the plantar flexion movement of the ankle joint from heel contact to sole contact will occur. Conceivable. By measuring the time factor from heel contact to sole contact, we examine the influence of the softness of the heel of the shoe on gait.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1.Shock absorption of shoes 2. Pain during walking 3.Ease of walking
Key secondary outcomes
1.Time from heel contact to foot contact
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male
Key inclusion criteria
1.Among drug-induced HIV-infected hemophiliacs, those diagnosed with hemophilic ankle disease
2.Individuals who can walk independently (with or without walking aids)
3.Those whose shoe size is 26.5 cm
4.Subjects who have consented to participate in the research
Key exclusion criteria
1.Subjects with painful skin problems around the foot and ankle joints
2.Persons judged by the principal investigator to be inappropriate for research participation
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Junko |
| Middle name | |
| Last name | Fujitani |
Organization
National Center for Global Health and Medicine
Division name
department of rehabilitation medicine
Zip code
162-8655
Address
1-21-1 toyama shinzyuku-ku,Tokyo
TEL
03-3202-7181
jufujita@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | Kazuko |
| Middle name | |
| Last name | Kikuchi |
Organization
National Center for Global Health and Medicine
Division name
department of rehabilitation medicine
Zip code
162-8655
Address
1-21-1 toyama shinzyuku-ku,Tokyo
TEL
03-3202-7181
Homepage URL
kkikuchi@hosp.ncgm.go.jp
Sponsor or person
Institute
National Center for Global Health and Medicine.
Department of rehabilitation medicine.
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center for Global Health and Medicine.
Address
1-21-1, toyama, shinjuku-ku, Tokyo
Tel
0332027181
rinrijm@hosp.ncgm.go.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
国立国際医療研究センター（東京都）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 12 | Month | 19 | 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
12
Results
Under analysis
Results date posted
| 2024 | Year | 04 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
hemophilia patients with HIV infection due to treatment with non-heat-treated blood
product
Participant flow
After obtaining informed consent, the primary and secondary endpoints will be measured.
Adverse events
none
Outcome measures
1.Shoe shock absorption
2.Pain during walking
3.Ease of walking
4.Time from heel contact to sole contact
Plan to share IPD
under consideration
IPD sharing Plan description
under consideration
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2022 | Year | 12 | Month | 19 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 19 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 19 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
Other
Other related information
Single center study
Management information
Registered date
| 2022 | Year | 10 | Month | 07 | Day |
Last modified on
| 2024 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055983
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