UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047655 |
|---|---|
| Receipt number | 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 | 2025/03/04 22:32:39 |
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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
Healthy
Classification by specialty
| Orthopedics | Rehabilitation medicine | Adult |
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
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
koji_onop@yahoo.co.jp
Sponsor or person
Institute
Shigei Hospital
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
1)Department of Physical Therapy, School of Health Science and Social Welfare, Kibi International University
2)Department of Rehabilitation, Kurashiki Heisei Hospital
3)Division of Physical Therapy, School of Rehabilitation, Faculty of Health and Social Services, Kanagawa University of Human Services
4)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
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
Completed
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
| 2024 | Year | 12 | Month | 31 | 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
| 2025 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054331
