NCT06662955

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started Oct 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress71%
Oct 2024Dec 2026

Study Start

First participant enrolled

October 20, 2024

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

October 25, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 29, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 19, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

December 12, 2025

Status Verified

December 1, 2025

Enrollment Period

2 years

First QC Date

October 25, 2024

Last Update Submit

December 11, 2025

Conditions

Keywords

ACLR

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Peak motor unit action potential (mV)

    From enrollment to the end of treatment at 2 weeks

Study Arms (2)

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

ExerciseBEHAVIORAL

Terminal knee extension exercise

Exercise without audible cues
audible cuesBEHAVIORAL

Terminal knee extension exercise with audible cues

Also known as: Exercise with audible cues
Exercise with audible cues

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy, Mahidol University

Salaya, Changwat Nakhon Pathom, 73170, Thailand

RECRUITING

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Komsak Sinsurin, PT, Ph.D., DPT

CONTACT

Sakda Nitkotom, B.Sc.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Paticipants are blinded groups allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst.Prof.Dr.

Study Record Dates

First Submitted

October 25, 2024

First Posted

October 29, 2024

Study Start

October 20, 2024

Primary Completion (Estimated)

October 19, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

December 12, 2025

Record last verified: 2025-12

Locations