UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045451 |
|---|---|
| Receipt number | R000051891 |
| Scientific Title | Does the use of an electric foot support reduce the burden of wheelchair foot support assistance? |
| Date of disclosure of the study information | 2021/09/24 |
| Last modified on | 2024/06/12 13:57:24 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Does the use of an electric foot support reduce the burden of wheelchair foot support assistance?
Acronym
Does the use of an electric foot support reduce the burden of wheelchair foot support assistance?
Scientific Title
Does the use of an electric foot support reduce the burden of wheelchair foot support assistance?
Scientific Title:Acronym
Does the use of an electric foot support reduce the burden of wheelchair foot support assistance?
Region
| Japan |
Condition
Condition
lumbago
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to determine how much the use of an electric foot support reduces the burden of raising and lowering the lower leg when assisting a wheelchair compared to the use of a conventional foot support.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
VAS on the sense of burden to be performed after the implementation of each condition
Key secondary outcomes
(1) Time required for each condition, (2) Results of movement analysis when performing assistive actions, (3) Other subjective opinions
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
| Device,equipment |
Interventions/Control_1
Participants will perform two types of foot support assistance, one using an electric elevating foot support and the other using a conventional foot support.
This is done once a week, and each session take 15 minutes.
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
| 25 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Third-year and fourth-year students of the department in the academic year 2021
Those who are able to obtain written consent to participate in the research of their own free will.
Key exclusion criteria
Students other than the third and fourth year students of this department in 2021.
Those who are expected to have difficulty in lifting and lowering the lower limbs of the participants, and those who are expected to have a negative impact on their health due to the heavy burden.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Gembu |
| Middle name | |
| Last name | Deguchi |
Organization
International University of Health and Welfare
Division name
Department of Occupational Therapy, Faculty of Health Science in Odawara
Zip code
250-8588
Address
1-2-25, Shiroyama, Odawara city, Kanagawa
TEL
0465-21-6500
g-deguchi@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Gembu |
| Middle name | |
| Last name | Deguchi |
Organization
International University of Health and Welfare
Division name
Department of Occupational Therapy, Faculty of Health Science in Odawara
Zip code
250-8588
Address
1-2-25, Shiroyama, Odawara city, Kanagawa
TEL
0465-21-6500
Homepage URL
g-deguchi@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
International University of Health and Welfare
Address
1-2-25, Shiroyama, Odawara city, Kanagawa
Tel
0465-21-0361
g-deguchi@iuhw.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 | 09 | Month | 24 | Day |
Related information
URL releasing protocol
https://www.jstage.jst.go.jp/article/resja/37/4/37_197/_article/-char/ja
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/resja/37/4/37_197/_article/-char/ja
Number of participants that the trial has enrolled
20
Results
In this study, we assessed the difference between the caregiver's subjective experience of caregiver burden when using a manual foot support and when using an electric elevating foot support. The results confirmed that the electric elevating foot support reduced the caregiver burden compared to the manual foot support, based on subjective results, including time results.
Results date posted
| 2024 | Year | 06 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 11 | Month | 01 | Day |
Baseline Characteristics
The subjects were 20 male and female university students, aged 20 to 23, who were majoring in occupational therapy and had learned how to assist people in wheelchairs.
Participant flow
Recruitment among universities conducting research
Adverse events
No particular problems
Outcome measures
Subjective fatigue, time required, free comment
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 09 | Month | 10 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 02 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 13 | Day |
Last follow-up date
| 2021 | Year | 11 | Month | 12 | Day |
Date of closure to data entry
| 2021 | Year | 12 | Month | 15 | Day |
Date trial data considered complete
| 2021 | Year | 12 | Month | 15 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 25 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 09 | Month | 10 | Day |
Last modified on
| 2024 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051891
