- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06662955
Exercise With Audible Cues on Motor Unit Behavior in Athletes With Anterior Cruciate Ligament Reconstruction (ACLR)
December 11, 2025 updated by: Komsak Sinsurin, Mahidol University
Terminal Knee Extension Exercise Synchronize With Audible Cues on Motor Unit Behavior of Vastus Medialis Muscle in Athletes With Anterior Cruciate Ligament Reconstruction
The closed kinetic chain (CKC) of terminal knee extension exercise (TKE) is designed to activate VM activity for knee injury training.
This CKC exercise is effective for highest recruiting muscle activity, especially safe for post-operative knee surgery.
The study of ACL reconstruction rehabilitation guideline suggests that exercises can be applied within the early phase of rehabilitation to prevent knee laxity and less knee pain compared to open chain exercise.
Therefore, it is interesting to investigate the effects of TKE exercise synchronized with metronome pace on change of VM motor unit behavior in post operative ACL reconstruction.
This study focuses on the immediate effect of 1-seesion TKE and expects that adding metronome during TKE will enhance neuromuscular control of VM and may change motor unit behavior.
Study Overview
Status
Recruiting
Intervention / Treatment
Detailed Description
This study investigates the effect of exercise with sensory integration technique on neuromuscular control in athletes with anterior cruciate ligament reconstruction.
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Komsak Sinsurin, PT, Ph.D., DPT
- Phone Number: 6855547313
- Email: komsak.sin@mahidol.edu
Study Contact Backup
- Name: Sakda Nitkotom, B.Sc.
- Phone Number: 0869853212
- Email: Sakda.nit@hotmail.com
Study Locations
-
-
Changwat Nakhon Pathom
-
Salaya, Changwat Nakhon Pathom, Thailand, 73170
- Recruiting
- Faculty of Physical Therapy, Mahidol University
-
Contact:
- Wanida Sawangnat, M.Sc.
- Phone Number: 20220 +66 24415450
- Email: wanida.swa@mahidol.ac.th
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Male or female participants who receive primary ACL reconstruction within 2 weeks with or without meniscus repair
- No or mild resting pain (Numeric rating scale ≤ 3)
- Reconstruction procedures using autograft including hamstrings or bone-patella bone grafts
- Age range 18-35 years (33).
- BMI of 18.5-25 kg/m² (34).
- Tegner activity scale ≥ level 4
Exclusion Criteria:
- Non-weight bearing within 2 weeks after the operation (prescription from surgeon)
- Hearing problem, such as being unable to hear the metronome sound or being unable to synchronize exercises with the metronome correctly
- Limitations in knee extension range caused by joint stiffness evaluated by using passive knee range of motion
- Unable to perform active and passive ≥ 30º knee flexion on the operative side
- History of serious injury or operation of lower back and lower extremities such as fracture
- Lower back or lower extremities pain within 6 months before the study
- On the pain killer medication
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Exercise without audible cues
Terminal knee extension exercise without audible cues
|
Terminal knee extension exercise
|
|
Experimental: Exercise with audible cues
Terminal knee extension exercise with audible cues
|
Terminal knee extension exercise with audible cues
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Average motor unit firing rate (pulse per second, pps)
Time Frame: From enrollment to the end of treatment at 2 weeks
|
Motor unit behavior of vastus medialis muscle: Average motor unit firing rate (pulse per second, pps)
|
From enrollment to the end of treatment at 2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Peak motor unit action potential (mV)
Time Frame: From enrollment to the end of treatment at 2 weeks
|
Motor unit behavior of vastus medialis muscle: Peak motor unit action potential (mV)
|
From enrollment to the end of treatment at 2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 20, 2024
Primary Completion (Estimated)
October 19, 2026
Study Completion (Estimated)
December 30, 2026
Study Registration Dates
First Submitted
October 25, 2024
First Submitted That Met QC Criteria
October 26, 2024
First Posted (Actual)
October 29, 2024
Study Record Updates
Last Update Posted (Actual)
December 12, 2025
Last Update Submitted That Met QC Criteria
December 11, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MU-CIRB 2024/242.3009
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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