UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053233 |
|---|---|
| Receipt number | R000060751 |
| Scientific Title | process analysis of daily activity for dementia in proximal femur fracture patients -A pre-post comparison study- |
| Date of disclosure of the study information | 2023/12/26 |
| Last modified on | 2024/03/29 16:35:49 |
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Basic information
Public title
Occupational therapy practice based on the process analysis of daily activity for dementia in proximal femur fracture patients -A pre-post comparison study-
Acronym
A pre-post comparison study
Scientific Title
process analysis of daily activity for dementia in proximal femur fracture patients -A pre-post comparison study-
Scientific Title:Acronym
A pre-post comparison study
Region
| Japan |
Condition
Condition
Proximal femur fracture patients
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to examine the reliability and validity of the Activities of Daily Living Process Analysis Chart for patients with proximal femur fractures and to examine the possible effects of occupational therapy intervention based on the Activities of Daily Living Process Analysis Chart using a within-group before/after comparison study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcomes were FIM, TMIG-IC, SF-8, GSES, and PADA-D performance and satisfaction.
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
Treatment
Type of intervention
| Other |
Interventions/Control_1
Using PADA-D to identify ADL items for intervention targets and approach them in a task-oriented manner
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
| 65 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients were defined as those 65 years of age or older with a diagnosis of proximal femur fracture.
Key exclusion criteria
Those who had difficulty making their own decisions, those whose ADLs were affected primarily by a significant physical disability other than a proximal femur fracture, those with concomitant delirium, and those with cerebrovascular disease were considered for exclusion.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kei |
| Middle name | |
| Last name | Takahashi |
Organization
Tokyo Metropolitan Rehabilitation Hospital
Division name
Rehabilitation Department Occupational Therapy Department
Zip code
131-0034
Address
2 14 1 Tsutsumidori, Sumida-ku, Tokyo
TEL
0336168600
tmr.ot.takahashi@outlook.jp
Public contact
Name of contact person
| 1st name | Kei |
| Middle name | |
| Last name | Takahashi |
Organization
Tokyo Metropolitan Rehabilitation Hospital
Division name
Rehabilitation Department Occupational Therapy Department
Zip code
131-0034
Address
2 14 1 Tsutsumidori, Sumida-ku, Tokyo
TEL
0336168600
Homepage URL
tmr.ot.takahashi@outlook.jp
Sponsor or person
Institute
Tokyo Metropolitan Rehabilitation Hospital
Institute
Department
Personal name
Funding Source
Organization
Tokyo Metropolitan Rehabilitation Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Metropolitan Rehabilitation Hospital
Address
2 14 1 Tsutsumidori, Sumida-ku, Tokyo
Tel
0336168600
tmr.ot.takahashi@outlook.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
| 2023 | Year | 12 | Month | 26 | 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
17
Results
On average, 29 occupational therapy sessions resulted in significant improvements in FIM, FIM-m, FIM-c, GSES and PADA-D satisfaction and performance. The SF-8 also showed significant improvements in general health and mental health. The TMIG-IC also showed a significant improvement, but the effect size was moderate. Table 7 shows the changes in the secondary indices. With the exception of the HADS (anxiety), the other indices showed significant improvements.
Results date posted
| 2024 | Year | 03 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with proximal femur fractures
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 03 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 12 | Month | 26 | Day |
Last modified on
| 2024 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060751
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
