Exercise With Audible Cues on Motor Unit Behavior in Athl... | NCT06662955

Studies
Exercise With Audible Cues on Motor Unit Behavior in Athletes With Anterior Cruciate Ligament Reconstruction

NCT06662955

Sponsor

Mahidol University

Status

Recruiting

Last Update Posted

Dec 12, 2025Actual

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Therapeutic Exercise
Physical Therapy Techniques
Neuromuscular Function

Interventions

audible cues
Exercise

Countries

Thailand

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 20, 2024Actual

Primary Completion Date

Oct 19, 2026Estimated

Completion Date

Dec 30, 2026Estimated

First Submitted Date

Oct 25, 2024

First Submission Date that Met QC Criteria

Oct 26, 2024

First Posted Date

Oct 29, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 11, 2025

Last Update Posted Date

Dec 12, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Exercise without audible cues	Active Comparator	Terminal knee extension exercise without audible cues	Behavioral: Exercise
Exercise with audible cues	Experimental	Terminal knee extension exercise with audible cues	Behavioral: audible cues

Interventions

Name	Type	Description	Arm Group Labels	Other Names
audible cues	Behavioral	Terminal knee extension exercise with audible cues	Exercise with audible cues

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)	From enrollment to the end of treatment at 2 weeks

Secondary Outcomes

Measure	Description	Time Frame
Peak motor unit action potential (mV)	Motor unit behavior of vastus medialis muscle: Peak motor unit action potential (mV)	From enrollment to the end of treatment at 2 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Komsak Sinsurin, PT, Ph.D., DPT	Contact	6855547313		komsak.sin@mahidol.edu
Sakda Nitkotom, B.Sc.	Contact	0869853212		Sakda.nit@hotmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Physical Therapy, Mahidol University	Recruiting	Salaya	Changwat Nakhon Pathom	73170	Thailand

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015444	Exercise

Ancestor Terms

ID	Term
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided