UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054090 |
|---|---|
| Receipt number | R000057914 |
| Scientific Title | Relationship between tibialis anterior muscle and erector spinae muscles in healthy individuals: a randomized controlled trial |
| Date of disclosure of the study information | 2024/08/31 |
| Last modified on | 2024/04/08 16:09:34 |
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Basic information
Public title
Relationship between tibialis anterior muscle and erector spinae muscles in healthy individuals: a randomized controlled trial
Acronym
Relationship between tibialis anterior muscle and erector spinae muscles in healthy individuals: a randomized controlled trial
Scientific Title
Relationship between tibialis anterior muscle and erector spinae muscles in healthy individuals: a randomized controlled trial
Scientific Title:Acronym
Relationship between tibialis anterior muscle and erector spinae muscles in healthy individuals: a randomized controlled trial
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Orthopedics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the extent of functional connection between tibialis anterior and erector spinae muscles.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Target muscle will be B/L Erector spinae.
Muscle functions
Range of Motion for trunk flexion
EMG activity during the maximum voluntary isometric contraction
Maximum torque of trunk extension
Key secondary outcomes
Target muscle will be B/L Erector spinae.
Muscle properties- Tone, stiffness and elasticity
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
The maximum voluntary isometric contraction of erector spinae muscle will be sustained till the output is decrease to 50% of the maximum muscle contraction of the dominant side, using a muscle force measurement device
Interventions/Control_2
The maximum voluntary isometric contraction of Hamstrings muscle will be sustained till the output is decrease to 50% of the maximum muscle contraction of the dominant side, using a muscle force measurement device
Interventions/Control_3
The maximum voluntary isometric contraction of Tibialis anterior muscle will be sustained till the output is decrease to 50% of the maximum muscle contraction of the dominant side, using a muscle force measurement device
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 and Female
Key inclusion criteria
Healthy individuals
Key exclusion criteria
History of Musculo-skeletal injuries/ neurological disorders in the lumbar region and lower extremities
Severe back pain
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Nidhya |
| Middle name | |
| Last name | Krishnamoorthy |
Organization
Tokyo Metropolitan University
Division name
Department of physical therapy, Graduate school of Human Health Sciences
Zip code
116-0012
Address
7 Chome-2-10 Higashiogu, Arakawa City, Tokyo
TEL
03-3819-1211
krishnamoorthy-nidhya@ed.tmu.ac.jp
Public contact
Name of contact person
| 1st name | Hideyuki |
| Middle name | |
| Last name | Usa |
Organization
Tokyo Metropolitan University
Division name
Department of physical therapy, Graduate school of Human Health Sciences
Zip code
116-0012
Address
7 Chome-2-10 Higashiogu, Arakawa City, Tokyo
TEL
03-3819-1211
Homepage URL
usa@tmu.ac.jp
Sponsor or person
Institute
Tokyo Metropolitan University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Metropolitan Government
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee, Tokyo Metropolitan University Arakawa Campus
Address
7 Chome-2-10 Higashiogu, Arakawa City, Tokyo
Tel
03-3819-1211
a-rinri@jmj.tmu.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 | 08 | 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
45
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
| 2022 | Year | 10 | Month | 06 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 26 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 08 | Day |
Last follow-up date
| 2023 | Year | 12 | 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 | 04 | Month | 08 | Day |
Last modified on
| 2024 | Year | 04 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057914
