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KEA vs Towel for Early Quad Activation Post Anterior Cruciate Ligament Reconstruction

ConditionsACL SurgeryQuadriceps Strength
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorJouf University

About this trial

The goal of this clinical trial is to learn if a novel Knee Extensors Activation (KEA) device can improve quadriceps muscle activation in adults after anterior cruciate ligament (ACL) reconstruction surgery. The study focuses on adults aged 18-45 years undergoing primary unilateral ACL reconstruction, a population commonly affected by this injury.

The main questions it aims to answer are:

Does using the KEA device lead to greater quadriceps muscle activation (measured via EMG) by postoperative Day 5 compared to standard care using a rolled towel?

Does the KEA device improve early knee function, reduce pain, and decrease fear of movement compared to the towel method?

Researchers will compare participants using the KEA device versus a control group using the conventional rolled towel during early postoperative rehabilitation to see if the KEA device provides better outcomes.

Participants will:

Begin quadriceps strengthening exercises on the first day after ACL surgery.

Be randomly assigned to use either the KEA device or a rolled towel for isometric quadriceps exercises.

Perform 3 sets of 10 repetitions of knee extension exercises, twice daily for 5 consecutive days.

Undergo assessment of quadriceps EMG activation and complete questionnaires (KOOS, IKDC, TSK, and VAS) on Day 5.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged 18 to 45 years

Undergoing primary unilateral anterior cruciate ligament (ACL) reconstruction (any graft type, any surgical technique)

Able and willing to participate in postoperative rehabilitation

Able to provide written informed consent

Disqualifiers

Bilateral knee surgeries (e.g., simultaneous ACL reconstruction on both knees)

Significant neuromuscular disorders that may affect rehabilitation or EMG readings

Cognitive impairment that would interfere with understanding or performing exercises

History of major lower limb surgery within the past year (excluding the current ACL surgery)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Knee Extensors Activation (KEA) Device

    Device

    A portable, non-electric device consisting of an inflatable cushion, pressure gauge, and digital counter. It provides objective feedback during isometric quadriceps exercises after ACL reconstruction. The device encourages full contraction by only counting repetitions that exceed a preset pressure threshold and return to baseline.

  • Conventional Towel-Based Exercise

    Other intervention

    Standard rehabilitation method using a rolled towel under the knee during quadriceps setting exercises. Patients perform isometric contractions without feedback or objective measurement. Repetitions are manually counted by the physiotherapist.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: KEA Device GroupExperimental treatment 1 intervention
Group B: Towel GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Quadriceps muscle activation (EMG amplitude)

Surface electromyography (EMG) amplitude of the rectus femoris, vastus medialis, and vastus lateralis during maximal voluntary isometric contraction. The outcome will be expressed as the root-mean-square (RMS) amplitude from the best of three trials. Higher values indicate greater muscle activation.

Time frame
Postoperative Day 5

Secondary outcomes

1

Pain intensity at rest and during exercise (VAS)

Pain will be measured using a 10 cm Visual Analogue Scale (VAS), scored from 0 (no pain) to 10 (worst possible pain). Two values will be recorded: average resting pain and peak pain during quadriceps exercises.

Time frame
Postoperative Day 5
2

Knee function (KOOS)

The Knee injury and Osteoarthritis Outcome Score (KOOS) will assess pain, symptoms, activities of daily living (ADL), sport/recreation, and quality of life. Each subscale is scored from 0 (worst) to 100 (best).

Time frame
Postoperative Day 5
3

Fear of movement (Tampa Scale of Kinesiophobia - TSK)

The TSK questionnaire assesses fear of movement or re-injury using 17 items scored from 1 to 4, with higher scores indicating greater kinesiophobia.

Time frame
Postoperative Day 5
4

Global knee function (IKDC Subjective Knee Form)

The International Knee Documentation Committee (IKDC) Subjective Knee Form is a patient-reported outcome measure that evaluates symptoms, function, and ability to participate in sports activities. Scores range from 0 to 100, with higher scores indicating better knee function.

Time frame
Postoperative Day 5

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jouf University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: