UMIN-ICDS Clinical Trial

Public title

A Study of the Relationship between Multiple Factors and Prognosis of Ability to Perform Activities of Daily Living in Patients with Proximal Femur Fracture

Acronym

A Study of the Relationship between Multiple Factors and Prognosis of Ability to Perform Activities of Daily Living in Patients with Proximal Femur Fracture

Scientific Title

A Study of the Relationship between Multiple Factors and Prognosis of Ability to Perform Activities of Daily Living in Patients with Proximal Femur Fracture

Scientific Title:Acronym

A Study of the Relationship between Multiple Factors and Prognosis of Ability to Perform Activities of Daily Living in Patients with Proximal Femur Fracture

Region

Japan

Condition

Proximal Femur Fracture

Classification by specialty

Geriatrics	Orthopedics	Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Falls are the most common non-bone-related risk factor in patients with proximal femur fractures. Risk factors for falls include mental and motor dysfunction due to cranial nerve disease, musculoskeletal disease, and medications. In conventional physical therapy, the risk of falls has been assessed based on questionnaires and evaluation of physical function and motor skills. However, in the elderly, the aforementioned physical and biological dysfunctions are intricately intertwined, making prediction and prevention by a single assessment difficult. Therefore, the purpose of this study is to establish an objective and reliable fall prediction tool based on the assessment of biological functions, focusing on nerve conduction velocity. The results obtained will enable us to ensure the safety of patients during hospitalization, shorten the length of hospital stay, and guarantee the health of the elderly.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Presence or absence of fall events during hospitalization

Key secondary outcomes

Age, gender, diagnosis, medical history, length of hospitalization, destination, independence of daily living score, Functional Independence Measure score, blood and biochemical data, and medications data

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients admitted to the recovery phase rehabilitation ward of Tsurugi Public Hospital on or after April 1, 2020 and discharged by March 31, 2022

Key exclusion criteria

Death and Discharge, Acute Additions

Target sample size

90

Name of lead principal investigator

1st name	Akira
Middle name
Last name	Kimura

Organization

Gunma Paz University Graduate School

Division name

Medical Science

Zip code

370-0006

Address

1-7-1 Toiyacho, Takasaki City, Gunma Prefecture

TEL

027-365-3366

Email

kimuaki@nifty.com

Name of contact person

1st name	Eisuke
Middle name
Last name	Takeshima

Organization

Hokuriku University

Division name

Faculty of Medical and Health Sciences, Department of Physical Therapy

Zip code

920-1180

Address

1-1 Taiyougaoka, Kanazawa City, Ishikawa Prefecture

TEL

076-229-1161

Homepage URL

Email

e-takeshima@hokuriku-u.ac.jp

Institute

Gunma Paz University Graduate School

Institute

Department

Personal name

Organization

Gunma Paz University Graduate School

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Gunma Paz University Graduate School

Address

1-7-1 Toiyacho, Takasaki City, Gunma Prefecture

Tel

027-365-3366

Email

kimuaki@nifty.com

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2024

Year

04

Month

23

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

96

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

Recruitment status

No longer recruiting

Date of protocol fixation

2023

Year

04

Month

06

Day

Date of IRB

2023

Year

04

Month

25

Day

Anticipated trial start date

2023

Year

04

Month

26

Day

Last follow-up date

2025

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Study design: Backward-looking observational study, analytical study
Study subjects: Subjects for the retrospective observational study will be patients who sustained a proximal femur fracture and were admitted to the recovery rehabilitation ward of Tsurugi Public Hospital on or after April 1, 2020, and discharged by March 31, 2022. In addition, for the cross-sectional study, patients with proximal femur fracture who were admitted to the Recovery and Rehabilitation Unit of the hospital between the approval of the ethics application and December 2023 will be included. The number of subjects for the retrospective observational study was 96.
DATA CONTENT: The backward-looking observational study will collect data currently measured in the medical record. Data to be collected will include age, gender, diagnosis, medical history, length of hospitalization (pre-admission period and admission period), destination, independence of daily living score (on admission and on discharge), functional independence assessment method score (on admission and on discharge), blood and biochemical data (on admission), and medications taken (on admission and during hospitalization).
Data collection method: The above data of the subjects will be collected from within their electronic medical records.
Method of analysis: The subjects will be divided into groups based on their history of fracture, history of previous medical history, multiple drug use, presence or absence of oral steroids, and good or bad blood biochemistry data, etc. The comparison of two groups will be statistically analyzed using t-test and Man-Whitney, the comparison of three or more groups will be analyzed using analysis of variance and kruskal-wallis, and the association will be analyzed using simple regression and multiple regression analysis. The association is statistically analyzed by using single regression or multiple regression analysis.

Registered date

2024

Year

04

Month

23

Day

Last modified on

2024

Year

04

Month

23

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061923