Effect of Open Kinetic Chain Knee Extension Exercises With Neuromuscular Electrical Stimulation in Patients With Post-ACL Reconstruction Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Superior University
- Enrollment
- 58
- Locations
- 1
- Primary Endpoint
- Lysholm Knee Scoring Scale
Study Overview
Brief Summary
"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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Group 1 (Experimental Group - OKC + NMES)
Intervention: Group 1 (Experimental Group - OKC + NMES) (Combination Product)
Group 2 (Control Group - OKC Only
Intervention: Group 2 (Control Group - OKC Only (Diagnostic Test)
Outcomes
Primary Outcomes
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.
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Muhammad Naveed Babur
Principal Investigator
Superior University