UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050638 |
|---|---|
| Receipt number | R000057685 |
| Scientific Title | Longitudinal evaluation of the association between walking pain and standing postural control and psychological factors in patients after single-lower limb fracture |
| Date of disclosure of the study information | 2023/03/21 |
| Last modified on | 2023/11/12 18:14:46 |
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Basic information
Public title
Longitudinal evaluation of the association between walking pain and standing postural control and psychological factors in patients after single-lower limb fracture
Acronym
Longitudinal evaluation of walking pain in patients after single-lower limb fracture
Scientific Title
Longitudinal evaluation of the association between walking pain and standing postural control and psychological factors in patients after single-lower limb fracture
Scientific Title:Acronym
Longitudinal evaluation of walking pain in patients after single-lower limb fracture
Region
| Japan |
Condition
Condition
patients of single-lower limb fracture
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to elucidate the mechanism of walking pain by evaluating walking pain, postural control, and psychological factors in patients with acute postoperative pain after fracture of the single-lower limb. In addition, we aim to clarify the influence of standing postural control and psychological factors on postoperative pain and prolonged walking pain in the acute phase by longitudinal evaluation.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Normal pain intensity
Pain at start of walking, pain at end of walking, average pain intensity from start to end of walking
Key secondary outcomes
TSK: Tampa Scale for Kinesiophobia-11
PCS: Pain Catastrophizing-6
FES: Falls Efficacy Scale
Posture control: Center of pressure: COP, Average forward and backward position, average left and right position, 95% of the rate limiter area, average movement speed
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
| 60 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients after fracture of single-lower limb within 2 months of injury.
Key exclusion criteria
Patients in the partial weight-bearing phase
Patients who score 23 or less on the Mini Mental State Examination (MMSE)
Patients who have higher brain dysfunction and have difficulty in answering the questionnaire.
Patients who have a history of orthopedic or central nervous system disease and have a difference in physical function between right and left sides of the body.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Soichiro |
| Middle name | |
| Last name | Matsuda |
Organization
Kio University Graduate School
Division name
Health Sciences Research Division
Zip code
635-0832
Address
4chome2ban2go, Umaminaka, Hiroyocho, Kitakasegigun, Nara, Japan
TEL
08056170802
chcocobaby.0802.26@outlook.jp
Public contact
Name of contact person
| 1st name | Soichiro |
| Middle name | |
| Last name | Matsuda |
Organization
Kio University Graduate School
Division name
Health Sciences Research Division
Zip code
635-0832
Address
4chome2ban2go, Umaminaka, Hiroyocho, Kitakasegigun, Nara, Japan
TEL
08056170802
Homepage URL
chcocobaby.0802.26@outlook.jp
Sponsor or person
Institute
Kio university
Institute
Department
Personal name
Funding Source
Organization
Kio university
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
Kio university
Address
4chome2ban2go, Umaminaka, Hiroyocho, Kitakasegigun, Nara, Japan
Tel
0745541601
chocobaby.0802.26@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 | 03 | Month | 21 | 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
5
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
Completed
Date of protocol fixation
| 2023 | Year | 03 | Month | 20 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 20 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 20 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No data.
Management information
Registered date
| 2023 | Year | 03 | Month | 20 | Day |
Last modified on
| 2023 | Year | 11 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057685
| Research Plan | |
|---|---|
| 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 |
