UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044992 |
|---|---|
| Receipt number | R000051380 |
| Scientific Title | Effect of custom-made cane on gait for hemiplegic stroke patients |
| Date of disclosure of the study information | 2021/10/20 |
| Last modified on | 2023/07/25 15:05:18 |
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Basic information
Public title
Effect of custom-made cane on gait for hemiplegic stroke patients
Acronym
Effect of custom-made cane on gait for hemiplegic stroke patients
Scientific Title
Effect of custom-made cane on gait for hemiplegic stroke patients
Scientific Title:Acronym
Effect of custom-made cane on gait for hemiplegic stroke patients
Region
| Japan |
Condition
Condition
hemiplegic stroke patients
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effectiveness of custom-made cane for hemiplegic stroke patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
10m gait speed
Key secondary outcomes
Results of three-dimensional gait analysis, Timed up & Go Test, six-minutes walking test(distance, Physical Cost Index, Visual Analog Scale), Usability evaluation(System Usability Scale, Quebec User Evaluation of Satisfaction with assistive Technology), QOL evaluation(EuroQOL 5demensions 5levels)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Patients who are initially evaluated with a conventional cane and then with a custom-made cane.
Interventions/Control_2
Patients who are initially evaluated with a custom-made cane and then with a conventional cane.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Hemiplegic stroke patients with a Functional Ambulation Categories score of 4 or higher (able to walk independently on level ground) using a single point cane or multiple point cane.
Key exclusion criteria
1) Severe cognitive dysfunction
2) Bilateral motor dysfunction
3) Cerebellar brain damage only
4) Difficulty in maintaining a static standing position without assistive device
5) Medical history of conditions that may affect walking
6) Severe visual or hearing dysfunction
7) Using crutch
8) Need to limit exercise load due to severe medical conditions (Myocardial infarction, Heart failure, COPD, etc)
9) Body weight more than 100kg
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Junpei |
| Middle name | |
| Last name | Ishikawa |
Organization
Welloop Inc.
Division name
Department of accounting
Zip code
498-0026
Address
43 Nishimaesinden, Uguiura-cho, Yatomi, Aichi 498-0026, JAPAN
TEL
0567-55-8253
ishikawa@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 of New Cane
Zip code
498-0026
Address
43 Nishimaesinden, Uguiura-cho, Yatomi, Aichi 498-0026, JAPAN
TEL
0567-55-8253
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
Japanese Society of Physical Therapy
Address
10-11-7, Sendagaya, Minato, Tokyo 106-0032, JAPAN
Tel
03-6804-1626
ethics@japanpt.or.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
| 2021 | Year | 10 | Month | 20 | 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
Terminated
Date of protocol fixation
| 2021 | Year | 07 | Month | 29 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 19 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 20 | Day |
Last follow-up date
| 2026 | Year | 12 | 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
| 2021 | Year | 07 | Month | 29 | Day |
Last modified on
| 2023 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051380
