UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058877 |
|---|---|
| Receipt number | R000067333 |
| Scientific Title | Does electrical muscle stimulation therapy for the quadriceps muscle after anterior cruciate ligament reconstruction affect neuromuscular activity and muscle strength |
| Date of disclosure of the study information | 2025/08/25 |
| Last modified on | 2025/08/24 14:47:12 |
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Basic information
Public title
Does electrical muscle stimulation therapy for the quadriceps muscle after anterior cruciate ligament reconstruction affect neuromuscular activity and muscle strength
Acronym
The effect of electrical muscle stimulation therapy on muscle activity in the quadriceps femoris after ACL reconstruction
Scientific Title
Does electrical muscle stimulation therapy for the quadriceps muscle after anterior cruciate ligament reconstruction affect neuromuscular activity and muscle strength
Scientific Title:Acronym
The effect of EMS on neuromuscular activity and muscle strength in the quadriceps after ACL reconstruction
Region
| Japan |
Condition
Condition
Anterior cruciate ligament injury
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify whether electrical muscle stimulation therapy applied to the quadriceps muscle after anterior cruciate ligament reconstruction surgery (up to 3 months post-surgery) affects neuromuscular activity and muscle strength.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
neuromuscular activity
Key secondary outcomes
Lower limb muscle strength, Patient-reported outcome measures, Return to sports
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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
Electrical muscle stimulation therapy for the quadriceps and general treatment program after anterior cruciate ligament reconstruction surgery (using our hospital's protocol)
Interventions/Control_2
General treatment program after anterior cruciate ligament reconstruction surgery (using our hospital's protocol)
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
Primary anterior cruciate ligament reconstruction
Using quadriceps tendon as a graft
Those who participated in sports activities prior to injury (Tegner activity level scale more than 7)
Key exclusion criteria
Those with multiple ligament injuries requiring surgery
Those who do not aim to return to sports
Those with a history of lower limb surgery
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takuya |
| Middle name | |
| Last name | Sengoku |
Organization
Kanazawa University
Division name
Department of Rehabilitation
Zip code
920-8641
Address
Takaramachi 13-1, Kanazawa, Ishikawa, Japan
TEL
076-265-2013
moo.49k.ree@gmail.com
Public contact
Name of contact person
| 1st name | Takuya |
| Middle name | |
| Last name | Sengoku |
Organization
Kanazawa University
Division name
Department of Rehabilitation
Zip code
920-8641
Address
Takaramachi 13-1, Kanazawa, Ishikawa, Japan
TEL
076-265-2013
Homepage URL
moo.49k.ree@gmail.com
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
Takaramachi 13-1, Kanazawa, Ishikawa, Japan
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 | 08 | Month | 25 | 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 | 08 | Month | 25 | 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 | 08 | Month | 24 | Day |
Last modified on
| 2025 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067333
