Anterior Cruciate Ligament InjuriesNCT06913543
Effect of Open Kinetic CKE Exercises With NES in Patients With Post-ACL Reconstruction Surgery
A study testing Group 1 (Experimental Group - OKC + NMES) in people with Anterior Cruciate Ligament Injuries, run by Superior University at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Anterior Cruciate Ligament Injuries
- What is being tested?
- Group 1 (Experimental Group - OKC + NMES)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Mar 2025to 20 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
MOVEBETTER 14-A Koh-e-Noor Road, Basement Salt N Pepper
Faisalābad, Punjab Province
About this study
Official title: 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.
Read the 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.
- Conditions
- Anterior Cruciate Ligament Injuries
- Being tested
- Group 1 (Experimental Group - OKC + NMES), Group 2 (Control Group - OKC Only
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 OnlyDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Experimental Group - OKC + NMES) | Experimental | Not described Receives: Combination Product: Group 1 (Experimental Group - OKC + NMES) |
| Group 2 (Control Group - OKC Only | Active comparator | Not described Receives: Diagnostic Test: Group 2 (Control Group - OKC Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start20 Mar 2025
- Primary completion20 Jun 2025 (estimated)
- Study completion20 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament InjuriesStudies of the same condition, open and under way.
- More trials run by Superior UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06913543
- Sponsor's protocol ID
- MSRSW/Batch-Fall23/806
- Status last verified
- Mar 2025
- First submitted
- 29 Mar 2025
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Open Kinetic Chain Knee Extension Exercises With Neuromuscular Electrical Stimulation in Patients With Post-ACL Reconstruction Surgery
- ClinicalTrials.gov ID
- NCT06913543
- Acronym / sponsor ID
- MSRSW/Batch-Fall23/806
- Conditions
- Anterior Cruciate Ligament Injuries
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 20 Mar 2025 (actual)
- Primary completion
- 20 Jun 2025 (estimated)
- Study completion
- 20 Feb 2026 (estimated)
- First posted
- 6 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Experimental Group - OKC + NMES) | Experimental | Combination Product: Group 1 (Experimental Group - OKC + NMES) |
| Group 2 (Control Group - OKC Only | Active comparator | Diagnostic Test: Group 2 (Control Group - OKC Only |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Combination product | Group 1 (Experimental Group - OKC + NMES) |
| Group 2 (Control Group - OKC OnlyOpen 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. | Diagnostic test | Group 2 (Control Group - OKC Only |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group 1 (Experimental Group - OKC + NMES) in people with Anterior Cruciate Ligament Injuries, run by Superior University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lysholm Knee Scoring Scale (time frame: 12 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.