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

Effect of Open Kinetic Chain Knee Extension Exercises With Neuromuscular Electrical Stimulation 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.

Study Overview

• Status: Active, not recruiting
• Conditions: Anterior Cruciate Ligament Injuries
• Intervention / Treatment: Combination product: Group 1 (Experimental Group - OKC + NMES); Diagnostic test: Group 2 (Control Group - OKC Only

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Faisalābad, Punjab, Pakistan
      • MOVEBETTER 14-A Koh-e-Noor Road, Basement Salt N Pepper

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1 (Experimental Group - OKC + NMES)	Combination product: Group 1 (Experimental Group - OKC + NMES); 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.
Active Comparator: Group 2 (Control Group - OKC Only	Diagnostic test: Group 2 (Control Group - OKC Only; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lysholm Knee Scoring Scale	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.	12 Months
Universal Goniometer	Measures ROM (Flexion & Extension). Interpretation: Knee flexion and extension are assessed against standard angles. Higher reliability and validity in measuring knee movement.	12 Months

Collaborators and Investigators

• Sponsor: Superior University

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2025
• Primary Completion (Estimated): June 20, 2025
• Study Completion (Estimated): February 20, 2026

Study Registration Dates

• First Submitted: March 29, 2025
• First Submitted That Met QC Criteria: March 29, 2025
• First Posted (Actual): April 6, 2025

Study Record Updates

• Last Update Posted (Actual): April 6, 2025
• Last Update Submitted That Met QC Criteria: March 29, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries; Anterior Cruciate Ligament Injuries
• Other Study ID Numbers: MSRSW/Batch-Fall23/806

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No