UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057186 |
|---|---|
| Receipt number | R000065353 |
| Scientific Title | Survey of impressions of patients and therapists about a new forearm support type walker with fall prevention function and a walker with standing assistance function |
| Date of disclosure of the study information | 2025/03/03 |
| Last modified on | 2025/07/22 19:04:43 |
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Basic information
Public title
Survey of impressions of patients and therapists about a new forearm support type walker with fall prevention function and a walker with standing assistance function
Acronym
Survey of impressions of patients and therapists about new walkers
Scientific Title
Survey of impressions of patients and therapists about a new forearm support type walker with fall prevention function and a walker with standing assistance function
Scientific Title:Acronym
Survey of impressions of patients and therapists about a walker with fall prevention function and a walker with standing assistance function
Region
| Japan |
Condition
Condition
Inpatients undergoing rehabilitation treatment and their therapists
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the impressions of patients and therapists regarding a forearm support walker with fall prevention function currently under development and a walker with standing assistance function
Basic objectives2
Others
Basic objectives -Others
Ease of walking and assistance
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Impressions of patients and therapists about the walker
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Two weeks of walking training using a forearm support walker with fall prevention function or a walker with standing assistance function
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) People who retain the ability to understand how to use a forearm support walker with fall prevention function and a walker with standing assistance function
2) People who require supervision and assistance when using a conventional forearm support type walker
3) People whose height and weight do not exceed those recommended for use with a forearm support walker with fall prevention function and a walker with standing assistance function
Key exclusion criteria
1) In case consent to participate in the study cannot be obtained from both the patient and the therapist in charge.
2) In case a doctor determines that it is inappropriate to conduct the study due to the patient's health condition, etc.
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Noriaki |
| Middle name | |
| Last name | Hattori |
Organization
Toyama University Hospital
Division name
Department of Rehabilitation
Zip code
930-0194
Address
2630 Sugitani, Toyama-shi, Toyama, Japan
TEL
076-434-2315
rehab@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Miyaji |
Organization
Toyama University Hospital
Division name
Department of Rehabilitation
Zip code
930-0194
Address
2630 Sugitani, Toyama-shi, Toyama, Japan
TEL
076-434-2315
Homepage URL
rehab@med.u-toyama.ac.jp
Sponsor or person
Institute
University of Toyama
Institute
Department
Personal name
Funding Source
Organization
self-procurement
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kumagai Gumi Co.,Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Toyama
Address
2630 Sugitani, Toyama-shi, Toyama, Japan
Tel
076-415-8857
kenrinri@adm.u-toyama.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
| 2025 | Year | 03 | Month | 03 | 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
6
Results
No plans to disclose the results publicly.
Results date posted
| 2025 | Year | 07 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The patients were five males and one female, with one in the 40s-60s age group and five in the 60s-80s age group.
The therapists were six males and zero females, with five in the 20s-40s age group and one in the 40s-60s age group. One of the therapists had lower back pain.
Participant flow
Six pairs of participants were assigned to receive two pairs of a forearm support walkers with fall prevention function and one pair of a walker with standing assistance function.
All participants were able to undergo rehabilitation treatment for the specified period and were able to complete questionnaires.
Adverse events
There were no adverse events.
Outcome measures
No plans to announce
Plan to share IPD
The anonymized survey results and videos will be shared with Kumagaya Gumi, the joint implementing organization.
IPD sharing Plan description
The anonymized survey results and videos of the walking session will be shared at the end of the monitor survey.
Toyama University's online storage will be used for sharing.
The shared survey results and videos will be used for future product development, and the survey results may be verbally presented as case examples during sales activities.
Progress
Recruitment status
Completed
Date of protocol fixation
| 2025 | Year | 01 | Month | 09 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 14 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 21 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 28 | Day |
Date of closure to data entry
| 2025 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2025 | Year | 07 | Month | 03 | Day |
Date analysis concluded
| 2025 | Year | 07 | Month | 13 | Day |
Other
Other related information
Management information
Registered date
| 2025 | Year | 03 | Month | 02 | Day |
Last modified on
| 2025 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065353
