UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056817 |
|---|---|
| Receipt number | R000064938 |
| Scientific Title | effectiveness of occupational therapy practice based on the process analysis of daily activity for dementia in patients with hip fractures a nonrandomized comparative study |
| Date of disclosure of the study information | 2025/04/01 |
| Last modified on | 2025/01/25 19:07:31 |
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Basic information
Public title
effectiveness of occupational therapy practice based on the process analysis of daily activity for dementia in patients with hip fractures a nonrandomized comparative study
Acronym
effectiveness of occupational therapy practice based on the process analysis of daily activity for dementia in patients with hip fractures a nonrandomized comparative study
Scientific Title
effectiveness of occupational therapy practice based on the process analysis of daily activity for dementia in patients with hip fractures a nonrandomized comparative study
Scientific Title:Acronym
effectiveness of occupational therapy practice based on the process analysis of daily activity for dementia in patients with hip fractures a nonrandomized comparative study
Region
| Japan |
Condition
Condition
hip fractures
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effectiveness of Occupational Therapy Practice Based on the Process Analysis of Daily Activity for Dementia for Patients with Hip Fracture
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Information on the subjects is collected from their medical records, including gender, age, diagnosis, level of care, Mini-Mental State Examination, and grip strength. The main indices are FIM and FIM-motor items (FIM-m), FIM-cognitive items (FIM-c), and Tokyo Metropolitan Institute of Gerontology Index of Competence (TMIG-IC) as indices of ADLs and IADLs. The MOS8-Item Short-Form Health Survey (SF-8) was used to measure quality of life. The General Self-Efficacy Scale (GSES) was used to measure mental/psychological status. To capture subjective changes in daily living activities, we measure satisfaction and performance of the PADA-D on a scale of 1 to 10.
Key secondary outcomes
In addition to the PADA-D scores, secondary measures included the 30-second chair stand test (CS-30) as a measure of lower limb muscle strength, the Numerical Rating Scale (NRS) as a measure of pain, the Pain Catastrophizing Scale (PCS) as a measure of pain, and the Hospital Anxiety a Depression Scale (HADS) as a measure of anxiety and depression.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
The intervention lasted 6 weeks, with PADAD-based interventions performed approximately 6 times per week.
Interventions/Control_2
Usually occupational therapy group.
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
Inclusion criteria were persons 65 years of age or older with a diagnosis of hip fracture who were admitted to Hospital A, which has subacute and convalescent wards.
Key exclusion criteria
Exclusion criteria were as follows: patients with decision-making difficulties, patients with a significant physical disability other than hip fracture, patients with delirium, and patients with cerebrovascular disease.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kei |
| Middle name | |
| Last name | Takahashi |
Organization
Tokyo Metropolitan Rehabilitation Hospital
Division name
Rehabilitation Center
Zip code
131-0034
Address
2-14-1 Tsutsumidori, Sumida-ku, Tokyo
TEL
03-3616-8600
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 Center
Zip code
131-0034
Address
2-14-1 Tsutsumidori, Sumida-ku, Tokyo
TEL
03-3616-8600
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
03-3616-8600
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
| 2025 | Year | 04 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 01 | Month | 25 | Day |
Last modified on
| 2025 | Year | 01 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064938
