UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050314 |
|---|---|
| Receipt number | R000057218 |
| Scientific Title | Evaluation of the Effectiveness of a T-Strap Shoehorn Type Short Leg Orthosis for the Treatment of Entropion in Patients with Hemiplegia after Stroke |
| Date of disclosure of the study information | 2024/03/31 |
| Last modified on | 2023/02/12 14:36:27 |
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Basic information
Public title
Evaluation of the Effectiveness of a T-Strap Shoehorn Type Short Leg Orthosis for the Treatment of Entropion in Patients with Hemiplegia after Stroke
Acronym
Evaluation of the Effectiveness of Short Leg Orthosis with T-Strap for Hemiplegic Patients with Stroke
Scientific Title
Evaluation of the Effectiveness of a T-Strap Shoehorn Type Short Leg Orthosis for the Treatment of Entropion in Patients with Hemiplegia after Stroke
Scientific Title:Acronym
Evaluation of the Effectiveness of Short Leg Orthosis with T-Strap for Hemiplegic Patients with Stroke
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to verify whether attaching a T-strap to the SHB is effective in correcting the medial foot for stroke hemiplegic patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ankle joint angle of rotation with and without T-strap.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are 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
With Tstrap
Interventions/Control_2
Without Tstrap
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
| 40 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Recovering stroke patients admitted to the target facility who are able to practice gait using an AFO will be included. Recruitment criteria are hemiplegic patients within 6 months of onset.
Key exclusion criteria
The patient shall have difficulty walking with an AFO even with the assistance of a physical therapist, difficulty understanding verbal instructions due to impaired consciousness or aphasia, or shall present with significant knee joint extension limitation or ankle joint dorsiflexion limitation.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | takaaki |
| Middle name | |
| Last name | arai |
Organization
Kowagishi Labolatory Co.,Ltd
Division name
sales department
Zip code
3050845
Address
341-1, Ohshirazuma, Tsukuba-shi, Tsukuba
TEL
0298757627
info@kowagishi.com
Public contact
Name of contact person
| 1st name | takaaki |
| Middle name | |
| Last name | arai |
Organization
Kowagishi Labolatory Co.,Ltd
Division name
sales department
Zip code
3050845
Address
341-1 Ohshirazuma Tsukuba city Tsukuba
TEL
0298757627
Homepage URL
t-a-1102@outlook.jp
Sponsor or person
Institute
Kowagishi Labolatory Co.,Ltd
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
Address
1398 Shimamicho, Kita-ku, Niigata City
Tel
025-257-4455
info@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
| 2024 | Year | 03 | Month | 31 | 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 | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 02 | Month | 12 | Day |
Last modified on
| 2023 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057218
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
