UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043424 |
|---|---|
| Receipt number | R000049312 |
| Scientific Title | Verification of the effect on satisfaction of load training device with sound feedback |
| Date of disclosure of the study information | 2021/02/24 |
| Last modified on | 2022/01/19 16:07:26 |
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Basic information
Public title
Verification of the effect on satisfaction of load training device with sound feedback
Acronym
Verification of the effect on satisfaction of load training device with sound feedback
Scientific Title
Verification of the effect on satisfaction of load training device with sound feedback
Scientific Title:Acronym
Verification of the effect on satisfaction of load training device with sound feedback
Region
| Japan |
Condition
Condition
legs fracture
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Use load training equipment for patients in the partial load phase after legs fracture to verify the superiority of the equipment in terms of satisfaction.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Satisfaction score(SUS Score)
Measured after 3 days of use
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Device,equipment |
Interventions/Control_1
Use of load training equipment by a physiotherapist for 20 minutes a day for 3 days
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with legs fractures during partial load period.
Patients with reduced walking ability.
Patients in the recovery phase rehabilitation ward of Matsuyama Rehabilitation Hospital.
Patients who can give written consent.
Key exclusion criteria
Patients whose function may be reduced by using the developed equipment.
Patients with reduced cognitive function.(MMSE<=23)
Undernourished patients.(ALB <= 3.0 [g/dl])
Those who cannot wear commercially available shoes due to illness
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Yoshikawa |
Organization
National Institute of Technology, Niihama College
Division name
Department of Mechanical Engineering
Zip code
792-8580
Address
Yagumotyo 7-1, Niihama City, Ehime Pref., Japan
TEL
0897-37-7701
yosikawa@mec.niihama-nct.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Yoshikawa |
Organization
National Institute of Technology, Niihama College
Division name
Department of Mechanical Engineering
Zip code
792-8580
Address
Yagumotyo 7-1, Niihama City, Ehime Pref., Japan
TEL
0897-37-7701
Homepage URL
yosikawa@mec.niihama-nct.ac.jp
Sponsor or person
Institute
National Institute of Technology, Niihama College
Institute
Department
Personal name
Funding Source
Organization
TOSA ELECTRONICS IND.CO.,LTD
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Matsuyama Rehabilitation Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Bioethics Committee of shikokutiku KOSEN
Address
Tyokushityo 355,Takamatsu City, Kagawa Pref.
Tel
087-869-3818
kenkyu@t.kagawa-nct.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
| 2021 | Year | 02 | Month | 24 | 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
9
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
Completed
Date of protocol fixation
| 2020 | Year | 02 | Month | 14 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 08 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 01 | Month | 02 | Day |
Date trial data considered complete
| 2022 | Year | 01 | Month | 02 | Day |
Date analysis concluded
| 2022 | Year | 01 | Month | 11 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 02 | Month | 24 | Day |
Last modified on
| 2022 | Year | 01 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049312
