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

NCT07040384 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-06-27

No results posted yet for this study

Summary

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.

Conditions

  • ACL Surgery
  • Quadriceps Strength

Interventions

DEVICE

Knee Extensors Activation (KEA) 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.

OTHER

Conventional Towel-Based Exercise

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.

Sponsors & Collaborators

  • Jouf University

    lead OTHER

Principal Investigators

  • Abdulmajeed Alfayyadh · Jouf University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-25
Primary Completion
2026-08-25
Completion
2026-12-10

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07040384 on ClinicalTrials.gov