UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058775 |
|---|---|
| Receipt number | R000067183 |
| Scientific Title | A longitudinal follow-up and intervention effect study of the association between kinematic data and fear of movement of knee flexion in the loaded position in post-TKA patients. |
| Date of disclosure of the study information | 2025/08/13 |
| Last modified on | 2025/08/12 22:28:47 |
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Basic information
Public title
A study to track the relationship between knee bending motion and fear of movement in patients after total knee replacement surgery, and to investigate the rehabilitative effects on fear of movement.
Acronym
Investigation of the relationship between the characteristics of movement and fear of movement in postoperative patients with total knee arthroplasty and research to determine the effects of rehabilitation.
Scientific Title
A longitudinal follow-up and intervention effect study of the association between kinematic data and fear of movement of knee flexion in the loaded position in post-TKA patients.
Scientific Title:Acronym
A longitudinal follow-up and intervention effect study of the association between kinematic data and fear of movement of knee flexion in the loaded position in post-TKA patients.
Region
| Japan |
Condition
Condition
Osteoarthritis of the knee (after total knee arthroplasty)
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to clarify the relationship between kinematic data and movement fear in weight-bearing knee flexion movements in patients who have undergone total knee arthroplasty (TKA), with the goal of obtaining scientific knowledge that will contribute to the establishment of clinical intervention guidelines. Furthermore, rehabilitation interventions will be implemented for patients with movement fear, and the effects of these interventions on movement fear and kinematic indicators will also be verified.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Correlation coefficients between kinematic data (maximum angle, maximum angular velocity, turnaround time, and start delay) and fear of movement (FearVAS and TSK-11) at 1, 3, and 6 months postoperatively. Baseline is 1 month postoperatively; changes in FearVAS, TSK-11, and PainVAS will be assessed at 3 and 6 months postoperatively.
Key secondary outcomes
Changes in FearVAS (during task execution), PainVAS (during task execution), Pain Catastrophizing Scale (PCS) score, maximum flexion angle, maximum flexion angular velocity, maximum extension angular velocity, and start delay of knee flexion movement under load ,Changes in knee joint extensor muscle strength (kgf/kg) Changes in knee joint extension muscle strength (kgf/kg), changes in range of motion of the flexion of the knee joint for transverse motion, changes in the Timed Up and Go test, changes in the 10-meter walk test, and changes in KOOS pain and ADL scores.
,hanges in adverse events (exacerbation of pain, falls, etc.) in the intervention study
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Pain neuroscience education plus graded exposure in addition to usual postoperative rehabilitation.
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
| 40 | years-old | < |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who have undergone total knee arthroplasty (TKA) with the same implant model performed by the same surgeon at Toshiyama-kai Kiba Hospital.
Key exclusion criteria
1. Patients with difficulty understanding tasks due to severe cognitive decline, 2. Patients with a history of central nervous system disease, 3. Patients with a history of surgery on other parts of the body within the past 3 months, 4. Patients with other lower limb diseases (hip osteoarthritis, rheumatism, etc.), 5. Patients with chronic pain from before surgery.
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Kawasaki |
Organization
Juzankai Medical Corporation, Kiba Hospital
Division name
Rehabilitation Center
Zip code
578-0941
Address
4-2-8 Iwatacho, Higashiosaka city, Osaka, Japan
TEL
080-615-0291
kawasakiyuuki1123@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Kawasaki |
Organization
Juzankai Medical Corporation, Kiba Hospital
Division name
Rehabilitation Center
Zip code
578-0941
Address
4-2-8 Iwatacho, Higashiosaka city, Osaka, Japan
TEL
080-6156-0291
Homepage URL
kawasakiyuuki1123@yahoo.co.jp
Sponsor or person
Institute
Other
Institute
Department
Personal name
YukiKawasaki
Funding Source
Organization
Other
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juzankai Medical Corporation, Kiba Hospital
Address
4-2-8 Iwatacho, Higashiosaka city, Osaka, Japan
Tel
080-6156-0291
kawasakiyuuki1123@yahoo.co.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
喜馬病院（大阪）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 08 | Month | 13 | 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
| 2025 | Year | 05 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 15 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 15 | Day |
Last follow-up date
| 2028 | 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 | 08 | Month | 12 | Day |
Last modified on
| 2025 | Year | 08 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067183
