UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053820 |
|---|---|
| Receipt number | R000061361 |
| Scientific Title | Relationship between changes in gait and ADL･QOL in post-arthroplasty patients |
| Date of disclosure of the study information | 2024/04/01 |
| Last modified on | 2025/09/11 12:19:39 |
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Basic information
Public title
Relationship between changes in gait and ADL･QOL in post-arthroplasty patients
Acronym
Relationship between changes in gait and ADL･QOL in post-arthroplasty patients
Scientific Title
Relationship between changes in gait and ADL･QOL in post-arthroplasty patients
Scientific Title:Acronym
Relationship between changes in gait and ADL･QOL in post-arthroplasty patients
Region
| Japan |
Condition
Condition
hip osteoarthritis, knee osteoarthritis
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to examine the changes in gait in post-arthroplasty patients and its relationsip with activities of daily living and quality of life.
Additionally, we inbestigate factors influencing gait at each time.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The purpose of this study is to examine the changes in gait in post-arthroplasty patients and its relationsip with activities of daily living and quality of life.
Gait, activities of daily living, and quality of life.(pre, 3weeks, 3months and 1year after surgery)
Key secondary outcomes
Lower limb strength(pre, 3weeks, 3months and 1year after surgery)
Lower limb angular velocity(pre, 3weeks, 3months and 1year after surgery)
Lower limb range of motion(pre, 3weeks, 3months and 1year after surgery)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who had total hip arthroplasty or total knee arthroplasty
The ability to walk 30m or more without assistance or with a cane
Key exclusion criteria
A participant was excluded if patients had any medical or neurological problem that would affect their ability to complete this trial, such as severe dementia, stroke, cardiac insufficiency, or acute respiratory failure.
Target sample size
146
Research contact person
Name of lead principal investigator
| 1st name | Minoru |
| Middle name | |
| Last name | Nagata |
Organization
Kobe Rosai Hospital
Division name
Central Rehabilitation Department
Zip code
651-0053
Address
4-1-23 Kagoikedori, Chuo-ku, Kobe City, Hyogo Prefecture, Japan
TEL
078-231-5901
mino-ru223@yahoo.ne.jp
Public contact
Name of contact person
| 1st name | Minoru |
| Middle name | |
| Last name | Nagata |
Organization
Kobe Rosai Hospital
Division name
Central Rehabilitation Department
Zip code
651-0053
Address
4-1-23 Kagoikedori, Chuo-ku, Kobe City, Hyogo Prefecture, Japan
TEL
078-231-5901
Homepage URL
rosai@kobeh.johas.go.jp
Sponsor or person
Institute
Kobe Rosai Hospital
Institute
Department
Personal name
Funding Source
Organization
research funds to promote the hospital functions of Japan Organization of Occupational Health and Safety
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
Kobe Rosai Hospital
Address
4-1-23 Kagoikedori, Chuo-ku, Kobe City, Hyogo Prefecture, Japan
Tel
078-231-5901
rosai@kobeh.johas.go.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
| 2024 | 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
(1) Primary Outcomes
Longitudinal changes in gait patterns assessed at the preoperative baseline, postoperative day 21, 3 months, and 1 year.
Associations between gait patterns and activities of daily living (ADL) as well as health-related quality of life (HRQOL).
Identification of demographic characteristics and lower limb functional parameters that influence gait patterns.
(2) Secondary Outcomes
Comparative analysis of physical function determinants of gait patterns between patients undergoing total hip arthroplasty (THA) and total knee arthroplasty (TKA).
Determination of functional predictors at postoperative day 21 associated with the risk of falls occurring within 1 year after surgery.
Identification of preoperative functional parameters predictive of functional outcomes at 1 year postoperatively in THA and TKA cohorts.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 06 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
cohort study
Patients admitted to the orthopedic department of Kobe Rosai Hospital, diagnosed with hip or knee OA and scheduled for THA and TKA.
Measurement items include demographics, gait, lower extremity muscle strength, lower extremity joint angular velocity, lower extremity joint range of motion, pain, actibities of daily living,and quality of life.
Management information
Registered date
| 2024 | Year | 03 | Month | 11 | Day |
Last modified on
| 2025 | Year | 09 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061361
