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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000047655
Receipt No. R000054331
Scientific Title Kinematic and psychological mechanisms of the effects of walking with poles on walking speed in postoperative patients with hip fracture
Date of disclosure of the study information 2022/05/10
Last modified on 2022/05/06

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Basic information
Public title Kinematic and psychological mechanisms of the effects of walking with poles on walking speed in postoperative patients with hip fracture
Acronym Kinematic and psychological mechanisms of the effects of walking with poles on walking speed in postoperative patients with hip fracture
Scientific Title Kinematic and psychological mechanisms of the effects of walking with poles on walking speed in postoperative patients with hip fracture
Scientific Title:Acronym Kinematic and psychological mechanisms of the effects of walking with poles on walking speed in postoperative patients with hip fracture
Region
Japan

Condition
Condition Hip fracture
Classification by specialty
Orthopedics Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the kinematic and psychological mechanisms of the effects of walking with poles on walking speed in postoperative patients with hip fracture
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes walking speed
Key secondary outcomes Lower limb muscle activity
Trunk acceleration
Trunk lean angle
Lower limb pain intensity
Fear of falling

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1) Patients diagnosed of hip fracture
(2) Patients undergone surgery for hip fracture
(3) Patients who can walk 10m with a T-cane after surgery
Key exclusion criteria (1) Patients suspected cognitive impairment (mini-mental state examination score < 20 points)
(2) Patients who cannot hold poles with both hands due to physical condition
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Koji
Middle name
Last name Ono
Organization Shigei Hospital
Division name Department of Rehabilitation
Zip code 710-0051
Address 2-30 Saiwaicho, Kurashiki City, Okayama
TEL 086-422-3655
Email koji_onop@yahoo.co.jp

Public contact
Name of contact person
1st name Koji
Middle name
Last name Ono
Organization Shigei Hospital
Division name Department of Rehabilitation
Zip code 710-0051
Address 2-30 Saiwaicho, Kurashiki City, Okayama
TEL 086-422-3655
Homepage URL
Email koji_onop@yahoo.co.jp

Sponsor
Institute Shigei Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor 1)Department of Rehabilitation, Kurashiki Heisei Hospital
2)Faculty of Health and Social Services, Kanagawa University of Human Services
3)Graduate school of Humanities and Social Sciences, Hiroshima University
Name of secondary funder(s) None

IRB Contact (For public release)
Organization Shigei Hospital Ethics Committee
Address 2-30 Saiwaicho, Kurashiki City, Okayama
Tel 086-422-3655
Email koji_onop@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 しげい病院(岡山県)/ Shigei Hospital (Okayama)

Other administrative information
Date of disclosure of the study information
2022 Year 05 Month 10 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 Preinitiation
Date of protocol fixation
2022 Year 04 Month 01 Day
Date of IRB
2021 Year 07 Month 01 Day
Anticipated trial start date
2022 Year 04 Month 01 Day
Last follow-up date
2023 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Method: The walking tasks are unilateral T-cane walking, bilateral T-cane walking and PW. The walking conditions are normal walking and tandem walking. The primary outcome is walking speed, and secondary outcomes are lower limb muscle activity, trunk acceleration, trunk lean angle, lower limb pain intensity, and fear of falling.

Management information
Registered date
2022 Year 05 Month 05 Day
Last modified on
2022 Year 05 Month 06 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054331

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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