UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058077 |
|---|---|
| Receipt number | R000066375 |
| Scientific Title | Temporal Changes in Dynamic Load Factors During One-Hand Support Walking with Parallel Bars and T-Cane Walking in Patients with Proximal Femoral Fractures |
| Date of disclosure of the study information | 2025/06/04 |
| Last modified on | 2025/06/04 10:08:37 |
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Basic information
Public title
Temporal Changes in Dynamic Load Factors During One-Hand Support Walking with Parallel Bars and T-Cane Walking in Patients with Proximal Femoral Fractures
Acronym
Temporal Changes in Dynamic Load Factors During One-Hand Support Walking with Parallel Bars and T-Cane Walking in Patients with Proximal Femoral Fractures
Scientific Title
Temporal Changes in Dynamic Load Factors During One-Hand Support Walking with Parallel Bars and T-Cane Walking in Patients with Proximal Femoral Fractures
Scientific Title:Acronym
Temporal Changes in Dynamic Load Factors During One-Hand Support Walking with Parallel Bars and T-Cane Walking in Patients with Proximal Femoral Fractures
Region
| Japan |
Condition
Condition
proximal femoral fracture
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we focus not only on the magnitude of static weight-bearing, but also on dynamic parameters during the transition from one-handed parallel bar walking to T-cane walking. Specifically, we analyze the temporal changes in maximum dynamic weight-bearing, loading rate (LR) - an indicator of shock absorption capacity during loading - and loading impulse, which represents the total force applied during the time the foot is in contact with the ground.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Dynamic loading parameters
Maximum dynamic weight-bearing: the peak force applied to the ground during walking
Loading rate (LR): an indicator of the body's ability to absorb impact during initial contact
Loading impulse: the total force applied over the time the foot is in contact with the ground
Key secondary outcomes
Temporal parameters
Gait speed
Time to reach maximum load
Stance time (left/right)
Swing time (left/right)
Double support time (left/right)
Spatial parameters
Stride length (left/right)
Step width
Step length (left/right)
Weight-bearing parameter
Static maximum weight-bearing on the affected side
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
| 70 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients hospitalized at Tums Sakura Hospital Edogawa after surgery for proximal femoral fracture
2. Patients able to perform one-handed parallel bar walking under supervision or higher level
3. Patients aged 70 years or older
4. Patients with an HDS-R score of 20 or higher who can understand the explanation and provide informed consent
5. Patients without apparent gait disturbances caused by neurological or musculoskeletal disorders based on medical history
6. Patients who have provided consent for participation in measurement
Key exclusion criteria
1. Patients with cognitive decline or other conditions that prevent understanding of instructions (HDS-R score of 19 or lower)
2. Patients for whom the procedure is not feasible due to medical restrictions (e.g., bed rest or non-weight-bearing orders)
3. Patients who are already able to walk with a cane or independently under supervision at the time of admission
4. Patients who used a cane or had lower walking ability before the injury
5. Patients with apparent gait disturbances caused by neurological or musculoskeletal disorders based on medical history
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | sumiko |
| Middle name | |
| Last name | yamamoto |
Organization
International University of Health and Welfare Graduate School
Division name
Department of assistive technological science
Zip code
107-8402
Address
4-1-26 Akasaka, Minato-ku, Tokyo
TEL
03-5574-3874
sumiko-y@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | koshiro |
| Middle name | |
| Last name | mizushina |
Organization
International University of Health and Welfare Graduate School
Division name
Department of assistive technological science
Zip code
107-8402
Address
4-1-26 Akasaka, Minato-ku, Tokyo
TEL
09064935046
Homepage URL
24s1174@g.iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare Graduate School
Institute
Department
Personal name
Funding Source
Organization
International University of Health and Welfare Graduate School
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
International University of Health and Welfare Graduate School
Address
4-1-26 Akasaka, Minato-ku, Tokyo
Tel
03-5574-3874
akasaka-nyushi@iuhw.ac.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
| 2025 | Year | 06 | Month | 04 | 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
| 2025 | Year | 06 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 06 | Month | 04 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This observational study aims to clarify the relationship between dynamic weight-bearing parameters (maximum weight-bearing, loading rate, and impulse) and the acquisition of T-cane walking in postoperative patients with proximal femoral fractures. Measurements will be conducted once a week for 10 strides at a comfortable walking speed. Weight-bearing patterns during one-handed parallel bar walking and T-cane walking will be analyzed. Ten patients admitted to a convalescent rehabilitation ward will be included. Routine rehabilitation will continue as usual, and no additional interventions will be introduced for research purposes. The study aims to identify key weight-bearing characteristics that contribute to improved walking independence.
Management information
Registered date
| 2025 | Year | 06 | Month | 04 | Day |
Last modified on
| 2025 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066375
