UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049129 |
|---|---|
| Receipt number | R000055964 |
| Scientific Title | Corrective effect of shoehorn-type short leg orthosis with T-strap on ankle varus |
| Date of disclosure of the study information | 2023/04/01 |
| Last modified on | 2022/10/05 18:28:17 |
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Basic information
Public title
Corrective effect of shoehorn-type short leg orthosis with T-strap on ankle varus
Acronym
Corrective effect of shoehorn-type short leg orthosis with T-strap on ankle varus
Scientific Title
Corrective effect of shoehorn-type short leg orthosis with T-strap on ankle varus
Scientific Title:Acronym
Corrective effect of shoehorn-type short leg orthosis with T-strap on ankle varus
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A shoehorn-type AFO with a T-strap was manufactured for stroke patients, and its effect on correcting ankle varus during walking was confirmed.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
joint angle
electromyogram
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Uses shoehorn type AFO with T-strap
Interventions/Control_2
Uses shoehorn type AFO
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Stroke patients presenting with hemiplegia
Key exclusion criteria
Subjects who have difficulty walking under the proximal supervision of a physical therapist, subjects who have difficulty understanding verbal instructions due to disturbance of consciousness or aphasia, and subjects who exhibit significant knee extension limitation or ankle dorsiflexion limitation.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Minoru |
| Middle name | |
| Last name | Murayama |
Organization
Niigata University of Health and Welfare
Division name
Faculty of Rehabilitation
Zip code
950-3198
Address
1398 Shimamicho, Kita Ward, Niigata City
TEL
0252574725
minoru-murayama@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Minoru |
| Middle name | |
| Last name | Murayama |
Organization
Niigata University of Health and Welfare
Division name
Faculty of Rehabilitation
Zip code
950-3198
Address
1398 Shimamicho, Kita Ward, Niigata City
TEL
0252574725
Homepage URL
minoru-murayama@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Niigata University of Health and Welfare
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
Niigata University of Health and Welfare Ethics Committee
Address
1398 Shimamicho, Kita Ward, Niigata City
Tel
0252574725
minoru-murayama@nuhw.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
| 2023 | Year | 04 | Month | 01 | 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 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | 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
| 2022 | Year | 10 | Month | 05 | Day |
Last modified on
| 2022 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055964
