UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000055040 |
|---|---|
| Receipt number | R000062716 |
| Scientific Title | Hip long-axis distraction mobilization test in healthy adults |
| Date of disclosure of the study information | 2024/07/24 |
| Last modified on | 2024/07/22 12:06:53 |
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Basic information
Public title
Hip long-axis distraction mobilization test in healthy adults
Acronym
Hip joint distraction test
Scientific Title
Hip long-axis distraction mobilization test in healthy adults
Scientific Title:Acronym
Hip joint distraction test
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to clarify the effects of the hip long-axis dissection mobilization with different force magnitudes on passive joint stiffness and Range of Motion in healthy individuals.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjects will be measured pre-intervention, intervention, and post-intervention on the same day. Hip flexion passive torque and hip extension passive torque will be measured before and after intervention.
Key secondary outcomes
Subjects will have hip flexion range of motion and hip extension range of motion measured before and after the intervention.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Hip traction is applied caudally along the long axis of the femur with the limb in the loose packed position with hip flexion 30 degree, abduction 30 degree, and mild external rotation.
Hip traction is applied for 15 seconds, held for 30 seconds, and followed by a 15 second rest period. This technique is repeated 10 times for a total of 10 minutes.
Interventions/Control_2
The magnitude of hip traction force shall be three groups: 25 N for the Low-force group, 50 N for the Medium-force group, and 70 N for the High-force group.
Interventions/Control_3
three groups
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
| 20 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy adult males (undergraduate and graduate students, physical therapists) who have been informed of the purpose and methods of the study and who have given written consent.
Key exclusion criteria
Exclusion criteria are musculoskeletal diseases of the hip, lower back, pelvis, and knee joints or a history of such diseases, and a positive hip instability test. A positive result is defined as the appearance of pain after performing the test.
Target sample size
42
Research contact person
Name of lead principal investigator
| 1st name | Yuichi |
| Middle name | |
| Last name | Takata |
Organization
Hokkaido Bunkyo University
Division name
Graduate School of Rehabilitation Sciences
Zip code
061-1449
Address
5-196-1 Koganechuo, Eniwa, Hokkaido 061-1449, Japan
TEL
0123340109
takata@do-bunkyodai.ac.jp
Public contact
Name of contact person
| 1st name | Kazushi |
| Middle name | |
| Last name | Kimura |
Organization
Hokkaido Bunkyo University
Division name
Graduate School of Rehabilitation Sciences
Zip code
0611449
Address
5-196-1 Koganechuo, Eniwa, Hokkaido 061-1449, Japan
TEL
0123340219
Homepage URL
k-kimura@do-bunkyodai.ac.jp
Sponsor or person
Institute
Hokkaido Bunkyo University
Institute
Department
Personal name
Yuichi Takata
Funding Source
Organization
Hokkaido Bunkyo University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokkaido Bunkyo University
Address
5-196-1 Koganechuo, Eniwa, Hokkaido 061-1449, Japan
Tel
0123340109
takata@do-bunkyodai.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
| 2024 | Year | 07 | Month | 24 | 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
42
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 11 | Month | 05 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 27 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 14 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 15 | 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 | 07 | Month | 22 | Day |
Last modified on
| 2024 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000062716
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| Registered date | File name |
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