UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053730 |
|---|---|
| Receipt number | R000061314 |
| Scientific Title | Effect of the use of lower limb orthoses on the psychological condition of patients admitted to a rehabilitation hospital. |
| Date of disclosure of the study information | 2024/02/28 |
| Last modified on | 2024/02/28 15:02:14 |
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Basic information
Public title
Effect of the use of lower limb orthoses on the psychological condition of patients admitted to a rehabilitation hospital.
Acronym
Effect of the use of lower limb orthoses on the psychological condition of patients admitted to a rehabilitation hospital.
Scientific Title
Effect of the use of lower limb orthoses on the psychological condition of patients admitted to a rehabilitation hospital.
Scientific Title:Acronym
Effect of the use of lower limb orthoses on the psychological condition of patients admitted to a rehabilitation hospital.
Region
| Japan |
Condition
Condition
patients with stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of lower limb orthoses on the psychological condition of patients with stroke who have had orthoses made, and the psychological changes in the use of lower limb orthoses after discharge from the hospital.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Score of Psychological Impact of Assistive Devices Scale
Key secondary outcomes
Score of Quebec User Evaluation of Satisfaction with assistive Technology
Score of Life space assessment
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Patients with cerebrovascular disease admitted to the Rehabilitation Unit on or after April 1, 2020, who had a lower limb orthosis made at the Brace Clinic
Key exclusion criteria
Patients discharged to a place other than their home
Other persons deemed unsuitable by the principal investigator
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Yabuki |
Organization
Mejiro University
Division name
Department of Physical Therapy
Zip code
339-8501
Address
320, Ukiya, Iwatsuki-ku, Saitama city, Saitama, Japan
TEL
048-797-2152
yabukij@ami.ipu.ac.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Yabuki |
Organization
Mejiro University
Division name
Department of Physical Therapy
Zip code
339-8501
Address
320, Ukiya, Iwatsuki-ku, Saitama city, Saitama, Japan
TEL
048-797-2152
Homepage URL
yabukij@ami.ipu.ac.jp
Sponsor or person
Institute
Mejiro University
Institute
Department
Personal name
Jun Yabuki
Funding Source
Organization
by myself
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Mejiro University
Address
320, Ukiya, Iwatsuki-ku, Saitama city, Saitama, Japan
Tel
048-797-2152
yabukij@mejiro.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
| 2024 | Year | 02 | Month | 28 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 06 | Month | 09 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 09 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 10 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Questionnaires will be administered at admission and two months after discharge.
Management information
Registered date
| 2024 | Year | 02 | Month | 28 | Day |
Last modified on
| 2024 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061314
