UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047599 |
|---|---|
| Receipt number | R000054278 |
| Scientific Title | Analysis of the use of a cane while walking in hemiplegic stroke patients |
| Date of disclosure of the study information | 2022/04/27 |
| Last modified on | 2023/04/28 16:54:44 |
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Basic information
Public title
Analysis of the use of a cane while walking in hemiplegic stroke patients
Acronym
Analysis of the use of a cane while walking in hemiplegic stroke patients
Scientific Title
Analysis of the use of a cane while walking in hemiplegic stroke patients
Scientific Title:Acronym
Analysis of the use of a cane while walking in hemiplegic stroke patients
Region
| Japan |
Condition
Condition
Stroke patients
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To perform an analysis of the use of a cane while walking in stroke paraplegic patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Analysis of the mechanical stress applied to the cane while walking
Key secondary outcomes
Results of 3-dimensional gait analysis
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Force applied to the cane and gait analysis when overground walking with a cane
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Hemiplegic stroke patients using a cane
Key exclusion criteria
Severe cognitive dysfunction
Bilateral disorder
Severe internal medicine or musculoskeletal disease
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Ryu |
| Middle name | |
| Last name | Kokuwa |
Organization
Welloop Inc.
Division name
Project for development new cane
Zip code
4980026
Address
43 Nishimaeshinden, Uguiuracho, Yatomi, Aichi, Japan
TEL
0567558253
kokuwa@welloop.co.jp
Public contact
Name of contact person
| 1st name | Ryu |
| Middle name | |
| Last name | Kokuwa |
Organization
Welloop Inc.
Division name
Project for development new cane
Zip code
4980026
Address
43 Nishimaeshinden, Uguiuracho, Yatomi, Aichi, Japan
TEL
0567558253
Homepage URL
kokuwa@welloop.co.jp
Sponsor or person
Institute
Welloop Inc.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Welloop Inc.
Address
43 Nishimaeshinden, Uguiuracho, Yatomi, Aichi, Japan
Tel
0567558253
tomoko@welloop.co.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
| 2022 | Year | 04 | Month | 27 | 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
24
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 04 | Month | 14 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 15 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 27 | 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 | 04 | Month | 27 | Day |
Last modified on
| 2023 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054278
