UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055358 |
|---|---|
| Receipt number | R000063263 |
| Scientific Title | Neuromuscular activity of the quadriceps muscle in patients undergoing anterior cruciate ligament reconstruction |
| Date of disclosure of the study information | 2024/08/28 |
| Last modified on | 2024/08/28 19:46:48 |
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Basic information
Public title
Neuromuscular activity of the quadriceps muscle in patients undergoing anterior cruciate ligament reconstruction
Acronym
Comparison of neuromuscular activity in the quadriceps muscle by graf tendon used in anterior cruciate ligament reconstruction
Scientific Title
Neuromuscular activity of the quadriceps muscle in patients undergoing anterior cruciate ligament reconstruction
Scientific Title:Acronym
Comparison of neuromuscular activity in the quadriceps muscle using the QT and HT methods
Region
| Japan |
Condition
Condition
Anterior cruciate ligament injry
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the neuromuscular activity of the quadriceps muscle in patients after anterior cruciate ligament reconstruction using the quadriceps tendon.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Neuromuscular activity (motor units, firing frequency, firing threshold, etc.)
Key secondary outcomes
Knee extensor strength
Return to Sports Rate
Subjective Questionnaire
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
| 12 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients after primary anterior cruciate ligament reconstruction
2. Patients who have been playing sports since before the injury
3. Patients who have given consent to participate in the study
Key exclusion criteria
1. A history of previous lower extremity surgery
2. Those whose pain has interfered with muscle strength measurements after 3 months postoperatively
3. Surgery on knee ligaments other than the anterior cruciate ligament is required
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Sengoku |
| Middle name | |
| Last name | Takuya |
Organization
Kanazawa university
Division name
Department of Rehabilitation
Zip code
920-8641
Address
Takaramachi 13-1, Kanazawa, Ishikawa, Japan
TEL
0762652013
moo.49k.ree@gmail.com
Public contact
Name of contact person
| 1st name | Sengoku |
| Middle name | |
| Last name | Takuya |
Organization
Kanazawa university
Division name
Department of Rehabilitation
Zip code
920-8641
Address
Takaramachi 13-1, Kanazawa, Ishikawa, Japan
TEL
0762652013
Homepage URL
moo.49k.ree@gmail.com
Sponsor or person
Institute
Kanazawa University
Institute
Department
Personal name
Funding Source
Organization
MEXT(Japan)
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kanazawa University
Address
Takaramachi 13-1, Kanazawa, Ishikawa, Japan
Tel
0762652110
rinri@adm.kanazawa-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
金沢大学附属病院（石川県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 08 | Month | 28 | 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
50
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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 04 | Month | 06 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 15 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 04 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To evaluate the postoperative course of a general treatment program after anterior cruciate ligament reconstruction in terms of neuromuscular activity at 4 and 7 months postoperatively.
The above results will be compared with the graf tendons used (quadriceps and hamstring tendons).
Management information
Registered date
| 2024 | Year | 08 | Month | 28 | Day |
Last modified on
| 2024 | Year | 08 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063263
