UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044926
Receipt number R000051316
Scientific Title Relationship between trunk rotation speed and walking speed in elderly patients after orthopedic surgery who are hospitalized in the convalescent rehabilitation ward
Date of disclosure of the study information 2021/08/01
Last modified on 2021/07/28 22:22:26

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Basic information

Public title

Relationship between trunk rotation speed and walking speed in elderly patients after orthopedic surgery who are hospitalized in the convalescent rehabilitation ward

Acronym

Relationship between trunk rotation speed and walking speed in elderly patients after orthopedic surgery who are hospitalized in the convalescent rehabilitation ward

Scientific Title

Relationship between trunk rotation speed and walking speed in elderly patients after orthopedic surgery who are hospitalized in the convalescent rehabilitation ward

Scientific Title:Acronym

Relationship between trunk rotation speed and walking speed in elderly patients after orthopedic surgery who are hospitalized in the convalescent rehabilitation ward

Region

Japan


Condition

Condition

After orthopedics

Classification by specialty

Orthopedics Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

For elderly people after orthopedic surgery who are hospitalized in the convalescent rehabilitation ward, perform upper and lower trunk rotation exercises that are simply set in the sitting position, and investigate the relationship with walking speed.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

trunk rotational movement speed

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

95 years-old >=

Gender

Male and Female

Key inclusion criteria

1.elderly patients (65 years old and over)
after orthopedic surgery who are admitted
to our hospital, convalescent rehabilitation ward
2.those who can walk while watching over 10m (use of wand is allowed)
3.both shoulder joints that can bend 90or more without pain
4.when the person can directly obtain the written consent

Key exclusion criteria

1.those who do not understand the research content and problem explanation
2.those with MMSE of 20 points or less and suspected dementia
3.postoperative patients with lumbar and thoracic spine after compression fracture of thoracolumbar spine

Target sample size

50


Research contact person

Name of lead principal investigator

1st name TOMOFUMI
Middle name
Last name KAWAMURA

Organization

Osaka Prefecture University

Division name

Graduate School of Comprehensive Rehabilitation

Zip code

583855

Address

3-7-30 Habikino, Habikino City, Osaka Prefecture

TEL

072-950-2111

Email

me701007@edu.osakafu-u.ac.jp


Public contact

Name of contact person

1st name TOMOFUMI
Middle name
Last name KWAMURA

Organization

Hoshigaoka Medical Center

Division name

Rehabilitation department

Zip code

5738511

Address

4-8-1 Hoshigaoka, Hirakata City, Osaka Prefecture

TEL

072-840-2641

Homepage URL


Email

rom.2018.0220@gmail.com


Sponsor or person

Institute

Osaka Prefecture University

Institute

Department

Personal name



Funding Source

Organization

Osaka Prefecture University

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

Hoshigaoka Medical Center

Address

4-8-1 Hoshigaoka, Hirakata City, Osaka Prefecture

Tel

072-840-2641

Email

rom_0502@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



Other administrative information

Date of disclosure of the study information

2021 Year 08 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


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Enrolling by invitation

Date of protocol fixation

2020 Year 10 Month 21 Day

Date of IRB

2020 Year 12 Month 01 Day

Anticipated trial start date

2020 Year 12 Month 17 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Cross-sectional study
The recruitment method is from December 2020 to December 2021. All patients in the convalescent rehabilitation ward of our facility who meet the selection criteria.
The measurement items are walking speed, trunk rotation speed, lower limb muscle strength, pain, functional independence measure, and cognitive function test.


Management information

Registered date

2021 Year 07 Month 21 Day

Last modified on

2021 Year 07 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051316