UMIN-CTR Clinical Trial

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
Institute	Osaka Prefecture University
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051316