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NCT Number: NCT06913543

Effect of Open Kinetic CKE Exercises With NES in Patients With Post-ACL Reconstruction Surgery

"Anterior cruciate ligament (ACL) reconstruction is a commonly performed surgical procedure for restoring knee stability in patients following ACL injuries. Despite surgical success, postoperative rehabilitation remains crucial for improving functional outcomes, addressing quadriceps strength deficits, and reducing recovery time.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Wounds and Injuries

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MOVEBETTER 14-A Koh-e-Noor Road, Basement Salt N Pepper

Faisalābad, Punjab Province, Pakistan

About this study

This study investigates the combined impact of open kinetic chain (OKC) knee extension exercises and neuromuscular electrical stimulation (NMES) on the functional recovery of post-ACL reconstruction patients. This randomized clinical trial involves 58 patients, divided into two groups: an experimental group receiving OKC knee extension exercises combined with NMES and a control group receiving OKC exercises alone. Functional outcomes, range of motion (ROM), and patient-reported outcomes (PROs) are assessed using validated tools.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Both genders aged 18-45 years
  • Subjects who have undergone unilateral primary ACL reconstruction surgery
  • Subjects who are exactly 4 weeks post-surgery at the start of the study
  • Subjects who received a hamstring tendon autograft or patellar tendon graft for ACL reconstruction
  • Subjects cleared by a physician to begin open kinetic chain exercises in their rehabilitation program
  • Subjects who are generally healthy with no significant comorbidities that could interfere with rehabilitation
  • Willingness to provide informed consent and commit to the entire duration of the study

Exclusion criteria

  • Presence of additional knee injuries (e.g., meniscal tears, collateral ligament injuries) that might affect rehabilitation
  • History of prior ACL injury or reconstruction on the same knee
  • Patients who underwent reconstruction of other ligaments along with the ACL
  • Presence of conditions (e.g., rheumatoid arthritis, osteoarthritis, uncontrolled diabetes) that could influence recovery
  • Any significant injury or surgery to the opposite knee within the last six months
  • Factors that indicate a high risk of non-compliance with the rehabilitation protocol, such as poor availability, or lack of commitment to follow the exercise regimen
  • Conditions affecting neuromuscular control that could interfere with exercise performance or rehabilitation response

Treatment and study plan

Group 1 (Experimental Group - OKC + NMES)

Combination Product

OKC Knee Extension Exercises:

Seated Knee Extensions:

Resistance bands or machine, 10-15 reps, 2-3 sets.

Straight Leg Raises:

With or without ankle weights, 12-15 reps, 2-3 sets.

Quadriceps Isometric Holds:

Held for 5-10 seconds, 10 reps, 2-3 sets.

Neuromuscular Electrical Stimulation (NMES):

Electrode Placement:

Over the motor points of the quadriceps.

Frequency:

35-50 Hz.

Pulse Duration:

200 microseconds.

Intensity:

Adjusted for strong yet tolerable contractions.

On-Off Cycle:

10 seconds on, 20 seconds off.

Group 2 (Control Group - OKC Only

Diagnostic Test

Open Kinetic Chain Knee Extension Exercises without NMES. Method & Details: The same OKC exercises as the experimental group but without NMES. All exercises are supervised by trained physiotherapists.

Primary outcomes

  1. Lysholm Knee Scoring Scale

    Time frame: 12 Months

    Measures knee function with a maximum score of 100.

    Scoring Interpretation:

    95-100 points: Excellent function. 84-94 points: Good function. 65-83 points: Fair function. <65 points: Poor function.

  2. Universal Goniometer

    Time frame: 12 Months

    Measures ROM (Flexion & Extension).

    Interpretation:

    Knee flexion and extension are assessed against standard angles. Higher reliability and validity in measuring knee movement.

Sponsors and collaborators

Lead sponsor

Superior University

Other

Registry information

Official study title

Effect of Open Kinetic Chain Knee Extension Exercises With Neuromuscular Electrical Stimulation in Patients With Post-ACL Reconstruction Surgery

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Apr 6, 2025
Registry last updated
Apr 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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