UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021751
Receipt number R000024986
Scientific Title Immediate effects of leg press exercises with tibial internal rotation on symptoms and function of individuals with medial knee osteoarthritis: A randomized controlled trial
Date of disclosure of the study information 2016/04/02
Last modified on 2016/04/25 18:07:15

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Basic information

Public title

Immediate effects of leg press exercises with tibial internal rotation on symptoms and function of individuals with medial knee osteoarthritis: A randomized controlled trial

Acronym

Immediate effects of leg press exercises with tibial internal rotation on symptoms and function of individuals with medial knee osteoarthritis: A randomized controlled trial

Scientific Title

Immediate effects of leg press exercises with tibial internal rotation on symptoms and function of individuals with medial knee osteoarthritis: A randomized controlled trial

Scientific Title:Acronym

Immediate effects of leg press exercises with tibial internal rotation on symptoms and function of individuals with medial knee osteoarthritis: A randomized controlled trial

Region

Japan


Condition

Condition

Knee osteoarthritis

Classification by specialty

Orthopedics Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To determine the effectiveness of a leg-press exercises with tibial internal rotation on improving pain and function

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

10 m walk test
The 10m walk test measuresd it after 20 minutes of intervention.

Key secondary outcomes

timed up-and-go test, knee flexion angle while squatting, knee pain during walking and squatting, difficulty during walking and squatting


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -investigator(s) and assessor(s) are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Leg-press activity with tibial internal-rotation (single session)

Interventions/Control_2

Leg-press activity with tibial neutral-rotation (single session)

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

50 years-old <=

Age-upper limit

80 years-old >=

Gender

Male and Female

Key inclusion criteria

(1) age between 50 and 80 years, (2) knee OA with a Kellgren and Lawrence (K/L) grade <4, and (3) knee extension deficit <10 degree

Key exclusion criteria

(1) bilateral knee OA, (2) acute symptoms, (3) rheumatoid arthritis, or (4) previous surgery involving either lower extremity

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazuyoshi Gamada

Organization

Hiroshima International University

Division name

Graduate School of Medical Technology and Health Welfare Sciences Major in Medical Engineering and Technology

Zip code


Address

555-36 Kurosegakuendai, Higashihiroshima-shi, Hiroshima

TEL

0823-70-4550

Email

kazgamada@ortho-pt.com


Public contact

Name of contact person

1st name
Middle name
Last name Kenji Hanada

Organization

Hiroshima International University

Division name

Graduate School of Medical Technology and Health Welfare Sciences Major in Medical Engineering and T

Zip code


Address

555-36 Kurosegakuendai, Higashihiroshima-shi, Hiroshima

TEL

0823-70-4550

Homepage URL


Email

guess_kenji@yahoo.co.jp


Sponsor or person

Institute

Hiroshima International University

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Fukuoka Rehabilitation Hospital

Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

福岡リハビリテーション病院(福岡)


Other administrative information

Date of disclosure of the study information

2016 Year 04 Month 02 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

Completed

Date of protocol fixation

2010 Year 06 Month 09 Day

Date of IRB


Anticipated trial start date

2010 Year 07 Month 09 Day

Last follow-up date

2010 Year 08 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2010 Year 10 Month 31 Day


Other

Other related information



Management information

Registered date

2016 Year 04 Month 02 Day

Last modified on

2016 Year 04 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024986


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name