Therapeutic ExerciseACLRNCT06662955
Exercise With Audible Cues on Motor Unit Behavior in Athletes With Anterior Cruciate Ligament Reconstruction
A study testing audible cues and Exercise in people with Therapeutic Exercise and Physical Therapy Techniques, run by Mahidol University at 1 site in Thailand.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Therapeutic Exercise, Physical Therapy Techniques, Neuromuscular Function
- What is being tested?
- audible cues and Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteThailand
- Study dates
- 20 Oct 2024to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site, 1 recruiting
- Recruiting
Faculty of Physical Therapy, Mahidol University
Salaya, Changwat Nakhon Pathom, 73170
Wanida Sawangnat, M.Sc., +66 24415450 ext. 20220, wanida.swa@mahidol.ac.th
About this study
Official title: 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.
Read the detailed description
This study investigates the effect of exercise with sensory integration technique on neuromuscular control in athletes with anterior cruciate ligament reconstruction.
- Being tested
- audible cues, Exercise
- Keywords
- ACLR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
audible cuesBehavioural
Also called Exercise with audible cues
Terminal knee extension exercise with audible cues
ExerciseBehavioural
Terminal knee extension exercise
| Study group | Role | What they receive |
|---|---|---|
| Exercise without audible cues | Active comparator | Terminal knee extension exercise without audible cues Receives: Behavioral: Exercise |
| Exercise with audible cues | Experimental | Terminal knee extension exercise with audible cues Receives: Behavioral: audible cues |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average motor unit firing rate (pulse per second, pps)
Motor unit behavior of vastus medialis muscle: Average motor unit firing rate (pulse per second, pps)
Measured: From enrollment to the end of treatment at 2 weeks
Secondary outcomes (1)
Peak motor unit action potential (mV)
Motor unit behavior of vastus medialis muscle: Peak motor unit action potential (mV)
Measured: From enrollment to the end of treatment at 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start20 Oct 2024
- Primary completion19 Oct 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Therapeutic ExerciseStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Komsak Sinsurin, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06662955
- Sponsor's protocol ID
- MU-CIRB 2024/242.3009
- Acronym
- ACLR
- Status last verified
- Dec 2025
- First submitted
- 25 Oct 2024
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Nitkotom S, Lertwanich P, Kiratisin P, Suntornon P, Sonsukong A, Rangsiyanon P, Tosapornsupaluck A, Vachalathiti R, Areerak K, Piamthipmanas T, Chaijenkij K, Sinsurin K. Auditory-cued terminal knee extension enhances vastus medialis motor unit function in the early phase following ACL reconstruction: a randomized controlled trial. Knee Surg Relat Res. 2026 Aug 14;38(1):42. doi: 10.1186/s43019-026-00343-3.
PubMed 42601629
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Terminal Knee Extension Exercise Synchronize With Audible Cues on Motor Unit Behavior of Vastus Medialis Muscle in Athletes With Anterior Cruciate Ligament Reconstruction
- ClinicalTrials.gov ID
- NCT06662955
- Acronym / sponsor ID
- ACLR / MU-CIRB 2024/242.3009
- Keywords
- ACLR
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 20 Oct 2024 (actual)
- Primary completion
- 19 Oct 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 29 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study investigates the effect of exercise with sensory integration technique on neuromuscular control in athletes with anterior cruciate ligament reconstruction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise without audible cues | Active comparator | Behavioral: ExerciseTerminal knee extension exercise without audible cues |
| Exercise with audible cues | Experimental | Behavioral: audible cuesTerminal knee extension exercise with audible cues |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| audible cuesAlso: Exercise with audible cuesTerminal knee extension exercise with audible cues | Behavioural | Exercise with audible cues |
| ExerciseTerminal knee extension exercise | Behavioural | Exercise without audible cues |
Primary outcome
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)
1 secondary outcome
Peak motor unit action potential (mV)
Time frame: From enrollment to the end of treatment at 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Derived from this study: PubMed 42601629Nitkotom S, Lertwanich P, Kiratisin P, Suntornon P, Sonsukong A, Rangsiyanon P, Tosapornsupaluck A, Vachalathiti R, Areerak K, Piamthipmanas T, Chaijenkij K, Sinsurin K. Auditory-cued terminal knee extension enhances vastus medialis motor unit function in the early phase following ACL reconstruction: a randomized controlled trial. Knee Surg Relat Res. 2026 Aug 14;38(1):42. doi: 10.1186/s43019-026-00343-3.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing audible cues and Exercise in people with Therapeutic Exercise and Physical Therapy Techniques, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Komsak Sinsurin, PT, Ph.D., DPT (6855547313, komsak.sin@mahidol.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average motor unit firing rate (pulse per second, pps) (time frame: From enrollment to the end of treatment at 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06662955, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.