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

NCT07040384 | Not Yet Recruiting

• 1 other identifier: Jouf University
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Anterior cruciate ligament; quadriceps activation; biofeedback; rehabilitation; electromyography; knee; randomized controlled trial

Outcome Measures

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.

  Postoperative Day 5

Secondary Outcomes (4)

• Pain intensity at rest and during exercise (VAS)

  Postoperative Day 5

• Knee function (KOOS)

  Postoperative Day 5

• Fear of movement (Tampa Scale of Kinesiophobia - TSK)

  Postoperative Day 5

• Global knee function (IKDC Subjective Knee Form)

  Postoperative Day 5

Study Arms (2)

KEA Device Group

EXPERIMENTAL

Participants in this arm will perform quadriceps setting exercises using the Knee Extensors Activation (KEA) device. The device includes an inflatable cushion, pressure gauge, and digital repetition counter. Beginning on postoperative Day 1, participants will complete two supervised sessions daily for five days. Each session includes 3 sets of 10 isometric contractions of the quadriceps, with each contraction held for 5 seconds. The KEA device provides real-time visual feedback, encouraging full-effort contractions. A repetition is only counted when the pressure exceeds a preset threshold and returns to baseline, ensuring correct performance. All sessions are supervised by a physiotherapist.

Device: Knee Extensors Activation (KEA) Device

Towel Group

ACTIVE COMPARATOR

Participants in this arm will perform the same quadriceps setting exercises using a conventional rolled towel placed under the knee. This represents the current standard of care. Beginning on postoperative Day 1, participants will complete two supervised sessions daily for five days. Each session consists of 3 sets of 10 isometric quadriceps contractions with 5-second holds. The physiotherapist provides verbal cues and manually counts repetitions. There is no objective feedback or automated monitoring of contraction effort or repetition quality. All other rehabilitation care is consistent between groups.

Other: Conventional Towel-Based Exercise

Interventions

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.

Also known as: KEA Device Group

KEA Device Group

Conventional Towel-Based Exercise OTHER

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.

Towel Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Able to comply with study procedures and complete the 5-day inpatient exercise program

You may not qualify if:

• 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)
• Concomitant injuries requiring extensive repair (e.g., complex ligament reconstructions beyond minor meniscal or collateral work)
• Any medical condition or postoperative complication that would prevent safe participation in the exercise program

Sponsors & Collaborators

• Jouf University: lead

Study Officials

• Abdulmajeed Alfayyadh

  Jouf University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abdulmajeed Alfayyadh

CONTACT

+966500568065; abalfayyadh@ju.edu.sa

Sulaiman Alanezi

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 18, 2025
• First Posted: June 27, 2025
• Study Start: August 25, 2025
• Primary Completion (Estimated): August 25, 2026
• Study Completion (Estimated): December 10, 2026
• Last Updated: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: August 25, 2025 to December 1, 2026