UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058805 |
|---|---|
| Receipt number | R000067246 |
| Scientific Title | Exploring Research for Elucidating Gait Control in Patients with Hip Joint Disorders |
| Date of disclosure of the study information | 2025/08/20 |
| Last modified on | 2025/08/15 06:12:07 |
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Basic information
Public title
Research on the gait patterns of individuals with hip disorders
Acronym
Gait of people with hip joint disorders
Scientific Title
Exploring Research for Elucidating Gait Control in Patients with Hip Joint Disorders
Scientific Title:Acronym
Gait Control in Patients with Hip Joint Disorders
Region
| Japan |
Condition
Condition
Patients with hip joint disorders, primarily focusing on proximal femoral fractures
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Postoperative gait recovery rates are low in patients with proximal femur fractures. Since gait inherently depends on the coordinated function of all lower limb muscles, there is a need to shift rehabilitation from focusing on functional improvement around the injury site to focusing on muscle coordination across the entire lower limb. Previous observational studies have reported that individuals who achieve independent walking after postoperative rehabilitation exhibit a specific muscle coordination pattern. This study aims to investigate the effect of introducing rubber tube support and electrical stimulation therapy as interventions to promote this muscle coordination pattern
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
co-activation synergies, equilibrium-point trajectory, stiffness ellipse, equilibrium-point manipulability
Key secondary outcomes
gait independence, gait speed, balance, muscle strength, range of motion
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Elastic band-based external tendon support
Interventions/Control_2
electrical stimulation
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
Patients who have undergone hip joint surgery
Patients who have achieved cane ambulation
Patients who have given their informed consent
Key exclusion criteria
Patients with cognitive impairment who can't understand the task
Patients unable to walk 10 meters with a cane
Patients with other diseases that impair walking
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Hirai |
Organization
The University of Osaka
Division name
Graduate School of Engineering Science
Zip code
560-8531
Address
1-3 Machikaneyamacho, Toyonaka, Osaka, Japan
TEL
06-6850-6111
hirai.hiroaki.es@osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Keisuke |
| Middle name | |
| Last name | Furukawa |
Organization
The University of Osaka
Division name
Graduate School of Engineering Science
Zip code
560-8531
Address
1-3 Machikaneyamacho, Toyonaka, Osaka, Japan
TEL
080-6158-0668
Homepage URL
furukawa.keisuke@hmc.me.es.osaka-u.ac.jp
Sponsor or person
Institute
The University of Osaka
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
Hoshigaoka Medical Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka University Research Ethics Review Committee
Address
2-2 Yamadaoka, Suita-shi, Osaka-fu, Japan
Tel
06-6210-8290
rinri@hp-crc.med.osaka-u.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
星ヶ丘医療センター（大阪府）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 08 | Month | 20 | 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
| 2023 | Year | 10 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 10 | Month | 19 | Day |
Last follow-up date
| 2028 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 08 | Month | 15 | Day |
Last modified on
| 2025 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067246
