UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062713 |
|---|---|
| Receipt number | R000071776 |
| Scientific Title | Gait changes in patients with hip osteoarthritis evaluated using an accelerometer |
| Date of disclosure of the study information | 2026/08/31 |
| Last modified on | 2026/08/27 18:18:56 |
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Basic information
Public title
Gait changes in patients with hip osteoarthritis evaluated using an accelerometer
Acronym
Gait changes in patients with hip osteoarthritis
Scientific Title
Gait changes in patients with hip osteoarthritis evaluated using an accelerometer
Scientific Title:Acronym
Gait changes in patients with hip osteoarthritis
Region
| Japan |
Condition
Condition
hip osteoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
By attaching an accelerometer to the trunk during a walking test, it is possible to capture changes in trunk posture and gait parameters associated with continued walking. The purpose of this study is to evaluate the characteristics of gait in patients with hip osteoarthritis by comparing them with healthy, ambulatory individuals.
Basic objectives2
Others
Basic objectives -Others
The presence or absence of changes in gait is evaluated by analyzing acceleration data.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Gait data obtained from subjects equipped with accelerometers are used to evaluate step length, walking speed, step count, walking duration, gait rhythm, and postural sway.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Subjects wearing accelerometers perform three Timed Up and Go (TUG) tests and one 6-minute walk test. This intervention is conducted only once.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Hip Osteoarthritis (OA) Group
Patients meeting all of the following criteria:
1)Outpatients attending the Department of Orthopedic Surgery at Iwate Medical University Hospital or Morioka City Hospital.
2)Patients with hip osteoarthritis who have no active cardiovascular or respiratory diseases requiring treatment.
3)Patients with hip osteoarthritis who provided written informed consent after receiving a thorough explanation of this study.
4)Aged 18 years or older.
Control Group (Individuals without hip disease or gait impairment)
Individuals meeting all of the following criteria:
1)Outpatients attending the Department of Orthopedic Surgery at Iwate Medical University Hospital or Morioka City Hospital who do not have hip disease.
2)Individuals without gait impairment and without active cardiovascular or respiratory diseases requiring treatment.
3)Individuals who provided written informed consent after receiving a thorough explanation of this study.
4)Aged 18 years or older.
Key exclusion criteria
Hip Osteoarthritis (OA) Group
1)Patients who are unable to walk.
2)Patients with symptomatic spinal deformities associated with conditions such as parkinsonism or myasthenia gravis.
3)Patients deemed inappropriate for participation in this study by the investigators.
Control Group (Individuals without hip disease or gait impairment)
1)Individuals with symptomatic spinal deformities associated with conditions such as parkinsonism or myasthenia gravis.
2)Individuals deemed inappropriate for participation in this study by the investigators.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Shinji |
| Middle name | |
| Last name | Tokunaga |
Organization
Iwate Medical University
Division name
Department of Orthopedic Surgery
Zip code
028-3695
Address
2-1-1 Idaidori, Yahaba-cho, Shiwa-gun, Iwate Prefecture
TEL
019-613-7111
tamushin.321@gmail.com
Public contact
Name of contact person
| 1st name | Shinji |
| Middle name | |
| Last name | Tokunaga |
Organization
Iwate Medical University
Division name
Department of Orthopedic Surgery
Zip code
028-3695
Address
2-1-1 Idaidori, Yahaba-cho, Shiwa-gun, Iwate Prefecture
TEL
019-613-7111
Homepage URL
tamushin.321@gmail.com
Sponsor or person
Institute
Iwate Medical University
Institute
Department
Personal name
Funding Source
Organization
N/A
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
Department of Orthopedic Surgery, Iwate Medical University
Address
2-1-1 Idaidori, Yahaba-cho, Shiwa-gun, Iwate Prefecture
Tel
019-613-7111
tamushin.321@gmail.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
| 2026 | Year | 08 | Month | 31 | Day |
Related information
URL releasing protocol
https://www.ima.iwate-med.ac.jp/jima.html
Publication of results
Unpublished
Result
URL related to results and publications
https://www.ima.iwate-med.ac.jp/jima.html
Number of participants that the trial has enrolled
79
Results
The timed-up-and-go test time and acceleration during 180-degree turns were compared across groups. Timed-up-and-go test time increased significantly, and the HOOS score decreased with hip osteoarthritis progression. Acceleration data during turning, particularly the mean squared deviation and root mean square values, showed distinct gait patterns at each stage, suggesting cautious turning movements in early and severe hip osteoarthritis, and compensatory movements in moderate hip osteoarthritis.
Results date posted
| 2026 | Year | 08 | Month | 27 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2026 | Year | 11 | Month | 01 | Day |
Baseline Characteristics
Hip Osteoarthritis Group
Patients with hip osteoarthritis undergoing outpatient care in the Department of Orthopedic Surgery at Iwate Medical University Hospital or Morioka City Hospital.
Control Group
Healthy individuals with no prior history of hip disease.
Participant flow
Hip Osteoarthritis Group
Patients with hip osteoarthritis undergoing outpatient care were invited to participate in the study. After receiving an explanation of the study procedures and providing written informed consent, they underwent testing.
Control Group (Healthy Controls)
Staff members at Morioka City Hospital were invited to participate in the study. After receiving an explanation of the study procedures and providing written informed consent, they underwent testing.
Adverse events
N/A
Outcome measures
TUG test time, Number of steps, Hip Disability and Osteoarthritis Outcome Score(HOOS), composite vector scalar(CVS), summed average waveform of CVS(SAWCVS), moving average waveform of the CVS(MAWCVS), averaged squared difference, root mean square(RMS)
Plan to share IPD
Identifiable personal details, such as IDs and names, are removed and replaced with non-identifying reference numbers to ensure that individuals cannot be directly identified before the data are used.
IPD sharing Plan description
Identifiable personal details, such as IDs and names, will be removed and replaced with non-identifying reference numbers to ensure that individuals cannot be directly identified prior to data usage. Furthermore, when publishing the findings of this study, no information that could identify the subjects will be included.
Research data from which personal information has been removed will be responsibly stored and managed during the study period inside a locked cabinet. Following the completion of the study, the data will be preserved in a locked shelf in the department office for five years. The retention period shall be five years from the date the completion of the study is reported. After the expiration of the retention period, electronic data will be completely erased from recording media, and paper documents will be destroyed using a shredder. Participating collaborative institutions will similarly strive to protect personal information and will appoint a personal information manager to ensure appropriate management.
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 10 | Month | 31 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 16 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2024 | 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
| 2026 | Year | 08 | Month | 27 | Day |
Last modified on
| 2026 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071776
