UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051376 |
|---|---|
| Receipt number | R000058174 |
| Scientific Title | Development of clinical prediction model (CPM) for core outcome in older adults with hip fractures |
| Date of disclosure of the study information | 2023/06/20 |
| Last modified on | 2023/06/19 13:14:28 |
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Basic information
Public title
Development of a prognostic model to predict core outcome in older adults with hip fractures
Acronym
Development of a prognostic model to predict core outcome in older adults with hip fractures
Scientific Title
Development of clinical prediction model (CPM) for core outcome in older adults with hip fractures
Scientific Title:Acronym
Development of clinical prediction model (CPM) for core outcome in older adults with hip fractures
Region
| Japan |
Condition
Condition
Hip fracture
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to develop a prognostic model to predict the core outcomes of patients with femoral neck/trochanteric fractures: walking, activities of daily living, pain, and quality of life.
Basic objectives2
Others
Basic objectives -Others
To develop a Clinical Prediction Model for core outcomes for older adults with hip fractures hospitalized in a convalescent rehabilitation ward.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Four core outcomes
1.Walking independence 2.Activities of daily living (ADL) 3.Pain 4.Quality of life (QOL)
Key secondary outcomes
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
| 65 | years-old | <= |
Age-upper limit
| 95 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1)hip fracture
(2)admitted to a convalescent rehabilitation ward and performed physical therapy
Key exclusion criteria
(1)difficulty walking before the injury of the hip fracture
(2)difficulty understanding instructions
(3)physician or physical therapist determines to be unsafe or difficult to evaluate
(4)able to walk independently at the time of admission to a convalescent rehabilitation ward
(5)pathological fractures caused by cancer or other diseases
(6)acetabular or polyarticular fractures
(7)for some reason did not receive standard physical therapy
(8)(Pain, quality of life outcomes only) Mini-Mental State Examination score 19 or lower
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Ohyama |
Organization
Hidaka Rehabilitation Hospital
Division name
Department of Rehabilitation
Zip code
370-2104
Address
2204 Maniwa Yoshii-machi, Takasaki, Gunma
TEL
027-388-2005
yuukiooyama@gmail.com
Public contact
Name of contact person
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Miyata |
Organization
Ibaraki Prefectural University of Health Science
Division name
Department of Physical Therapy
Zip code
300-0394
Address
4669-2, Ami-Machi, Inashiki-gun, Ibaraki
TEL
029-888-4000
Homepage URL
miyatak@ipu.ac.jp
Sponsor or person
Institute
Hidaka Rehabilitation Hospital
Institute
Department
Personal name
Funding Source
Organization
Ibaraki Prefectural University of Health Science
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
Hidaka Rehabilitation Hospital
Address
2204 Maniwa Yoshii-machi, Takasaki, Gunma
Tel
027-388-2005
reha-rhc@hidaka-kai.com
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 | 06 | Month | 20 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 03 | Month | 28 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 18 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 21 | 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
Study design: Prospective cohort study
Recruitment methods: Patients admitted to the convalescent rehabilitation ward on or after June 1, 2023, who meet the selection and exclusion criteria.
Outcomes: Walking independence (FAC: Functional Ambulation Categories), Activities of Daily Living (BI: Barthel Index), Pain (VRS: Verbal Rating Scale, NRS: Numeric Rating Scale), Quality of Life (EQ-5D: EuroQol 5-Dimension)
Predictors:
Patient characteristic information: (1) age, (2) sex, (3) Body Mass Index, (4) pre-fracture mobility, (5) fracture type, (6) number of medications, (7) Duration from injury to surgery, (8) history of fracture, (9) complications, (10) Mini Nutritional Assessment Short-Form (MNA-SF), (11) length of hospital stay (investigated after discharge)
Performance test: (1) Berg Balance Scale (BBS), (2) Mini-Mental State Examination (MMSE), (3) 30 sec chair stand test (CS -30), (4) Verbal Rating Scale (VRS), (5) Numeric Rating Scale (NRS), (6) Knee extension strength (MMT: manual muscle testing), (7) Short Forms of Pain Catastrophizing Scale (SF-PCS), (8) Short Forms of Pain Self-Efficacy Questionnaire (SF-PSEQ), (9) Comfortable walking speed, (10) Maximum walking speed, (11) Timed up & go test (TUG), (12) The Short Falls Efficacy Scale-International (Short FES-I)
Content of Physical Therapy: All subjects receive standard physical therapy for 40-60 minutes per day. The program is similar at each hospital. Examples include range-of-motion for the lower extremities, muscle strengthening, basic movement, standing balance, walking, and activities of living for discharge.
Management information
Registered date
| 2023 | Year | 06 | Month | 19 | Day |
Last modified on
| 2023 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058174
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