UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055653 |
|---|---|
| Receipt number | R000063604 |
| Scientific Title | Comparative Analysis of Ground Reaction Forces and Spatiotemporal Gait Parameters in Older Adults with Sway-Back Posture and Chronic Low Back Pain: A Cross-Sectional Study |
| Date of disclosure of the study information | 2024/09/27 |
| Last modified on | 2024/09/27 20:36:54 |
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Basic information
Public title
Comparative Analysis of Ground Reaction Forces and Spatiotemporal Gait Parameters in Older Adults with Sway-Back Posture and Chronic Low Back Pain: A Cross-Sectional Study
Acronym
Comparative Analysis of Ground Reaction Forces and Spatiotemporal Gait Parameters in Older Adults with Sway-Back Posture and Chronic Low Back Pain: A Cross-Sectional Study
Scientific Title
Comparative Analysis of Ground Reaction Forces and Spatiotemporal Gait Parameters in Older Adults with Sway-Back Posture and Chronic Low Back Pain: A Cross-Sectional Study
Scientific Title:Acronym
Comparative Analysis of Ground Reaction Forces and Spatiotemporal Gait Parameters in Older Adults with Sway-Back Posture and Chronic Low Back Pain: A Cross-Sectional Study
Region
| Asia(except Japan) |
Condition
Condition
CROSS SECTIONAL STUDY
Classification by specialty
| Medicine in general | Geriatrics | Rehabilitation medicine |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparative Analysis of Ground Reaction Forces and Spatiotemporal Gait Parameters in Older Adults with Sway-Back Posture and Chronic Low Back Pain: A Cross-Sectional Study
Basic objectives2
Others
Basic objectives -Others
Comparative Analysis of Ground Reaction Forces and Spatiotemporal Gait Parameters in Older Adults with Sway-Back Posture and Chronic Low Back Pain: A Cross-Sectional Study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
GRFs, including anteroposterior, vertical, and mediolateral forces, and spatiotemporal parameters such as stride time, cadence, stride length, gait speed, and stance
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Medicine | Other |
Interventions/Control_1
NO TREATMENT
Interventions/Control_2
NO INTERVENTION
Interventions/Control_3
NO INTERVENTION
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
| 60 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
CLBP; exhibited a sway-back posture
Key exclusion criteria
radicular pain below the knee; known spinal pathology other than osteoarthritis (e.g., recent trauma, vertebral compression fractures;ankylosing spondylitis, metastatic carcinoma); a history of lumbar surgery; severely limited mobility
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | AMIR |
| Middle name | |
| Last name | LETAFATKAR |
Organization
KHARAZMI university
Division name
KHARAZMI university
Zip code
34512001
Address
Karaj
TEL
34512001
kharazmi@yahoo.com
Public contact
Name of contact person
| 1st name | amir |
| Middle name | |
| Last name | letafatkar |
Organization
KHARAZMI university
Division name
KHARAZMI university
Zip code
34512001
Address
karaj
TEL
34512001
Homepage URL
amirletafatkar.ce.khu@gmail.com
Sponsor or person
Institute
KHARAZMI university
Institute
Department
Personal name
Funding Source
Organization
no funding
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
shiraz medical university
Address
shiraz
Tel
0
mohammad.karimi.rehabilitation@gmail.com
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
| 2024 | Year | 09 | Month | 27 | 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
36
Results
-
Results date posted
| 2024 | Year | 09 | Month | 27 | Day |
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
Terminated
Date of protocol fixation
| 2019 | Year | 05 | Month | 03 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 11 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 06 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 09 | Month | 27 | Day |
Last modified on
| 2024 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063604
