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

NCT ID: NCT06913543

Last Updated: 2025-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-20

Study Completion Date

2026-02-20

Brief Summary

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"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

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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.

Conditions

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Anterior Cruciate Ligament Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Group 1 (Experimental Group - OKC + NMES)

Group Type EXPERIMENTAL

Group 1 (Experimental Group - OKC + NMES)

Intervention Type 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

Group Type ACTIVE_COMPARATOR

Group 2 (Control Group - OKC Only

Intervention Type 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.

Interventions

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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.

Intervention Type COMBINATION_PRODUCT

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Superior University

OTHER

Sponsor Role lead

Responsible Party

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Muhammad Naveed Babur

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Faisalābad, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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MSRSW/Batch-Fall23/806

Identifier Type: -

Identifier Source: org_study_id

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