UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059991 |
|---|---|
| Receipt number | R000068585 |
| Scientific Title | Effects of neuromuscular electrical stimulation on quadriceps muscle thickness after anterior cruciate ligament reconstruction using quadriceps tendon: a prospective randomized controlled trial |
| Date of disclosure of the study information | 2025/12/05 |
| Last modified on | 2025/12/05 14:32:11 |
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Basic information
Public title
How electrical muscle stimulation affects quadriceps muscle thickness in patients after anterior cruciate ligament reconstruction using quadriceps tendon?
Acronym
Effect of electrical muscle stimulation on quadriceps muscle thickness in patients after ACL reconstruction using quadriceps tendon
Scientific Title
Effects of neuromuscular electrical stimulation on quadriceps muscle thickness after anterior cruciate ligament reconstruction using quadriceps tendon: a prospective randomized controlled trial
Scientific Title:Acronym
Effect of EMS on quadriceps muscle thickness after ACL reconstruction using QT autograft: a prospective randomized controlled trial
Region
| Japan |
Condition
Condition
Anterior cruciate ligament injury
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In patients who undergo anterior cruciate ligament reconstruction using quadriceps tendon, postoperative recovery of knee extensor strength is often insufficient, potentially delaying safe and early return to sports. The aim of this study is to examine, in a prospective randomized controlled trial, whether electrical muscle stimulation of the quadriceps modifies quadriceps muscle thickness after ACL reconstruction using quadriceps tendon.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in quadriceps muscle thickness according to the presence or absence of electrical muscle stimulation (thickness of the rectus femoris, vastus lateralis, vastus medialis, and vastus intermedius measured by ultrasonography preoperatively and at 3 and 6 months postoperatively, and the change in muscle thickness at each time point compared between the intervention and control groups).
Key secondary outcomes
Lower limb muscle strength
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Standard postoperative physical therapy program after anterior cruciate ligament reconstruction plus electrical muscle stimulation applied to the quadriceps muscle.
Interventions/Control_2
Standard postoperative physical therapy program after anterior cruciate ligament reconstruction.
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
| 29 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
- Patients undergoing primary anterior cruciate ligament reconstruction
- Patients in whom a quadriceps tendon autograft is used for ACL reconstruction
- Patients who participated in sports activities before injury (Tegner Activity Level Scale > 6)
Key exclusion criteria
- Patients with multi-ligament knee injuries
- Patients who do not aim to return to sports
- Patients with a history of lower limb surgery or neuromuscular diseases
Target sample size
52
Research contact person
Name of lead principal investigator
| 1st name | Yushin |
| Middle name | |
| Last name | Mizuno |
Organization
Kanazawa University
Division name
Section of Rehabilitation
Zip code
920-8641
Address
13-1, Takaramachi, Kanazawa, Ishikawa
TEL
076-265-2013
mizuno@med.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Yushin |
| Middle name | |
| Last name | Mizuno |
Organization
Kanazawa University
Division name
Section of Rehabilitation
Zip code
920-8641
Address
13-1, Takaramachi, Kanazawa, Ishikawa
TEL
076-265-2013
Homepage URL
mizuno@med.kanazawa-u.ac.jp
Sponsor or person
Institute
Kanazawa University
Institute
Department
Personal name
Funding Source
Organization
MTG Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kanazawa University
Address
13-1, Takaramachi, Kanazawa Ishikawa
Tel
076-265-2110
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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | Month | 05 | 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
| 2024 | Year | 06 | Month | 10 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 19 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 05 | Day |
Last follow-up date
| 2029 | Year | 03 | 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 | 12 | Month | 05 | Day |
Last modified on
| 2025 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068585
