UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000048564
Receipt number R000055338
Scientific Title Investigation of knee gliding motion on cartilage degeneration: Cohort study
Date of disclosure of the study information 2022/08/03
Last modified on 2023/12/26 16:58:08

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Basic information

Public title

Investigation of knee gliding motion on cartilage degeneration: Cohort study

Acronym

Investigation of knee gliding motion on cartilage degeneration

Scientific Title

Investigation of knee gliding motion on cartilage degeneration: Cohort study

Scientific Title:Acronym

Investigation of knee gliding motion on cartilage degeneration

Region

Japan


Condition

Condition

older people

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine longitudinally the relationship between pattern of intra-joint motion in knee during gait and the cartilage degeneration.

Basic objectives2

Others

Basic objectives -Others

To examine longitudinally the relationship between pattern of intra-joint motion in knee during gait and the cartilage degeneration.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

cartilage thickness

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


Not applicable

Gender

Male and Female

Key inclusion criteria

Community-dwelling elderly
Independent ADL

Key exclusion criteria

history of knee surgery
Musculoskeletal disease
Impaired cognitive function

Target sample size

120


Research contact person

Name of lead principal investigator

1st name Shinya
Middle name
Last name Ogaya

Organization

Saitama Prefectural University

Division name

Division of Physical Therapy, School of Health and Social Services

Zip code

343-8540

Address

820 Sannomiya, Koshigaya-shi, Saitama

TEL

048-971-0500

Email

ogaya-shinya@spu.ac.jp


Public contact

Name of contact person

1st name Shinya
Middle name
Last name Ogaya

Organization

Saitama Prefectural University

Division name

Division of Physical Therapy, School of Health and Social Services

Zip code

343-8540

Address

820 Sannomiya, Koshigaya-shi, Saitama

TEL

048-971-0500

Homepage URL


Email

ogaya-shinya@spu.ac.jp


Sponsor or person

Institute

Saitama Prefectural University

Institute

Department

Personal name



Funding Source

Organization

Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Saitama Prefectural University Research ethics committee

Address

820 Sannomiya, Koshigaya-shi, Saitama

Tel

048-971-0500

Email

ogaya-shinya@spu.ac.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

2022 Year 08 Month 03 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

2022 Year 08 Month 28 Day

Date of IRB

2022 Year 07 Month 04 Day

Anticipated trial start date

2022 Year 08 Month 29 Day

Last follow-up date

2024 Year 09 Month 05 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

We observe knee cartilage thickness, osteophytes, edema, pain, stiffness, tenderness, crepitus, and palpating warmth.


Management information

Registered date

2022 Year 08 Month 03 Day

Last modified on

2023 Year 12 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055338


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name