UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056001 |
|---|---|
| Receipt number | R000063999 |
| Scientific Title | Effect of nuerodynamics on tibial nerve stiffness and dynamic balance -a randomized controlled trial- |
| Date of disclosure of the study information | 2024/10/31 |
| Last modified on | 2025/03/21 15:23:17 |
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Basic information
Public title
Effect of nuerodynamics on tibial nerve stiffness and dynamic balance -a randomized controlled trial-
Acronym
Effect of nuerodynamics on tibial nerve stiffness and dynamic balance -a randomized controlled trial-
Scientific Title
Effect of nuerodynamics on tibial nerve stiffness and dynamic balance -a randomized controlled trial-
Scientific Title:Acronym
Effect of nuerodynamics on tibial nerve stiffness and dynamic balance -a randomized controlled trial-
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the effects of Neural Mobilisation on tibial nerve stiffness and dynamic balance.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Tibial nerve stiffness, Dynamic balance (Y-balance)
Key secondary outcomes
Ankle dorsiflexion ranges of motion with Unloading and loading, straight leg raise angle, modified straight leg raise angle, Gastrocnemius muscle stiffness
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Maneuver |
Interventions/Control_1
Neurodynamics(6 sets of 10 repetitions)
Interventions/Control_2
Static Stretch(4 sets of 30 seconds)
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
| 18 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Modified straight leg raise angle less than 60 degree
Positive Modified Straight Leg Raise Test
Key exclusion criteria
Participants with a history of lower back or lower limb surgery
Target sample size
42
Research contact person
Name of lead principal investigator
| 1st name | Kengo |
| Middle name | |
| Last name | Kawanishi |
Organization
Morinomiya University of Medical Sciences
Division name
Inclusive Medical Science Research Institute
Zip code
559-8611
Address
1-26-16 Nankoukita Suminoe ward, Osaka city, Osaka prefecture
TEL
0666166911
kengo_kawanishi@morinomiya-u.ac.jp
Public contact
Name of contact person
| 1st name | Kengo |
| Middle name | |
| Last name | Kawanishi |
Organization
Morinomiya University of Medical Sciences
Division name
Inclusive Medical Science Research Institute
Zip code
559-8611
Address
1-26-16 Nankoukita Suminoe ward, Osaka city, Osaka prefecture
TEL
0666166911
Homepage URL
kengo_kawanishi@morinomiya-u.ac.jp
Sponsor or person
Institute
Morinomiya University of Medical Sciences
Institute
Department
Personal name
Kengo Kawanishi
Funding Source
Organization
Morinomiya University of Medical Sciences
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
Morinomiya University of Medical Sciences
Address
1-26-16 Nankoukita Suminoe ward, Osaka city, Osaka prefecture
Tel
0666166911
kengo_kawanishi@morinomiya-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
森ノ宮医療大学
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | Month | 31 | 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
| 2024 | Year | 10 | Month | 31 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 27 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 31 | Day |
Last follow-up date
| 2025 | Year | 11 | Month | 01 | 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 | 10 | Month | 31 | Day |
Last modified on
| 2025 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063999
