Anterior Cruciate Ligament InjuriesNCT06997679
Effects of Continuous Passive Movements vs Intermittent Compression in Patients With Post ACL Reconstruction Surgery
A study testing Patients receiving CPM and Patients receiving intermittent compression in people with Anterior Cruciate Ligament Injuries, run by Superior University at 1 site in Pakistan.
Trial summary
ACL Reconstruction Surgery remains a prevalent and debilitating condition, despite invasive and non-invasive approaches aimed at reducing pain and improving function. This study investigates the additional benefits of Continuous Passive Motion (device based exercise) and Intermittent Compression Therapy (device based… Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Anterior Cruciate Ligament Injuries
- What is being tested?
- Patients receiving CPM and Patients receiving intermittent compression
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 25 Feb 2025to 1 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed by Orthopedic Surgeon and patients who have undergone ACL reconstruction surgery
- Patients who have undergone arthroscopic ACL reconstruction surgery
- Both male and female
- Patients who are within 4th week post-operatively
- Aged between 20-50
Who cannot join
- Concomitant injuries such as meniscal tears or ligament sprains
- Patients who have undergone previous knee surgery, including ACL reconstruction
- Neurological Condition
- Cardiovascular disease
- Patients with allergies or sensitivities to the materials used in the CPM or IC devices
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Continuous Passive Movements Versus Intermittent Compression in Patients With Post ACL Reconstruction Surgery
ACL Reconstruction Surgery remains a prevalent and debilitating condition, despite invasive and non-invasive approaches aimed at reducing pain and improving function. This study investigates the additional benefits of Continuous Passive Motion (device based exercise) and Intermittent Compression Therapy (device based program) in individuals with Post ACL Reconstruction Surgery.
Read the detailed description
The researcher employs a randomized controlled trial methodology. Participants are enrolled into two groups: one receiving Continuous Passive Motion (CPM), and the other receiving Intermittent Compression Therapy(IC).
- Conditions
- Anterior Cruciate Ligament Injuries
- Being tested
- Patients receiving CPM, Patients receiving intermittent compression
- 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.
Patients receiving CPMDiagnostic test
Group A was treated with Continuous Passive Motion for 30-45 minutes for 2 sessions per day for 8 weeks. CPM can be initiated in the immediate post-operative period, typically within 24-48 hours after surgery. Range of motion will be 0-90 degrees of flexion, with a gradual increase in range over time. Speed is 1-2 cycles per minute. Therapist will Monitor patients for pain and discomfort during CPM, and adjust the protocol as needed. Therapist will Monitor patients range of motion and adjust the CPM protocol to ensure optimal progress. Therapist will monitor patients' knee functions and adjusts the CMP protocol to ensure optimal progress
Patients receiving intermittent compressionCombination product
Group B was treated with Intermittent Compression Therapy for 30-45 minutes for 2 sessions (morning and evening) per day for 8 weeks. Therapist stand beside the patient .IC therapy initiated in the immediate post-operative period, typically within 24-48 hours after surgery .Pressure of device between 30-40 mmHg and Cycle time is 10-30 seconds inflation, 10-30 seconds deflation. Therapist will Monitor patients for pain and discomfort during IC therapy, and adjust the protocol as needed. Therapist will Monitor patients' swelling and edema, and adjust the IC therapy protocol to ensure optimal progress. Therapist will Monitor patients' knees functions and adjust the IC therapy protocol to ensure optimal progress.
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving CPM | Experimental | Not described Receives: Diagnostic Test: Patients receiving CPM |
| Patients receiving intermittent compression | Active comparator | Not described Receives: Combination Product: Patients receiving intermittent compression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog scale VAS
The 10-point numeric scale ranges from '0' representing "no pain" to '10' representing "pain as bad as you can imagine" or "worst pain imaginable".
Measured: 12 Months
Knee injury and osteoarthritis outcome score KOOS
The questionnaire has been designed to evaluate Assess the symptoms, function, and quality of life of patients with knee injuries (ACL) or osteoarthritis. There are 5 sections with 42 questions. Each section total score is 100. Each question score between 0-4.Score of 8-10 points is considered clinically significant. Symptoms includes 7 questions which between 0-100. Severe symptoms (0-30), Moderate symptoms (31-60), Mild symptoms (61-100)
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 posted30 May 2025
- Study start25 Feb 2025
- Primary completion1 Jul 2025 (estimated)
- Study completion1 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
- 50 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
- NCT06997679
- Sponsor's protocol ID
- MSRSW/Batch-Fall23/825
- Status last verified
- May 2025
- First submitted
- 21 May 2025
- Last updated
- 30 May 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 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Continuous Passive Movements Versus Intermittent Compression in Patients With Post ACL Reconstruction Surgery
- ClinicalTrials.gov ID
- NCT06997679
- Acronym / sponsor ID
- MSRSW/Batch-Fall23/825
- Conditions
- Anterior Cruciate Ligament Injuries
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 25 Feb 2025 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 30 May 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.
ACL Reconstruction Surgery remains a prevalent and debilitating condition, despite invasive and non-invasive approaches aimed at reducing pain and improving function. This study investigates the additional benefits of Continuous Passive Motion (device based exercise) and Intermittent Compression Therapy (device based program) in individuals with Post ACL Reconstruction Surgery.
Detailed description
The researcher employs a randomized controlled trial methodology. Participants are enrolled into two groups: one receiving Continuous Passive Motion (CPM), and the other receiving Intermittent Compression Therapy(IC).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients receiving CPM | Experimental | Diagnostic Test: Patients receiving CPM |
| Patients receiving intermittent compression | Active comparator | Combination Product: Patients receiving intermittent compression |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Diagnosed by Orthopedic Surgeon and patients who have undergone ACL reconstruction surgery
- Patients who have undergone arthroscopic ACL reconstruction surgery
- Both male and female
- Patients who are within 4th week post-operatively
- Aged between 20-50
Key exclusion criteria (5 listed)
- Concomitant injuries such as meniscal tears or ligament sprains
- Patients who have undergone previous knee surgery, including ACL reconstruction
- Neurological Condition
- Cardiovascular disease
- Patients with allergies or sensitivities to the materials used in the CPM or IC devices
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 |
|---|---|---|
| Patients receiving CPMGroup A was treated with Continuous Passive Motion for 30-45 minutes for 2 sessions per day for 8 weeks. CPM can be initiated in the immediate post-operative period, typically within 24-48 hours after surgery. Range of motion will be 0-90 degrees of flexion, with a gradual increase in range over time. Speed is 1-2 cycles per minute. Therapist will Monitor patients for pain and discomfort during CPM, and adjust the protocol as needed. Therapist will Monitor patients range of motion and adjust the CPM protocol to ensure optimal progress. Therapist will monitor patients' knee functions and adjusts the CMP protocol to ensure optimal progress | Diagnostic test | Patients receiving CPM |
| Patients receiving intermittent compressionGroup B was treated with Intermittent Compression Therapy for 30-45 minutes for 2 sessions (morning and evening) per day for 8 weeks. Therapist stand beside the patient .IC therapy initiated in the immediate post-operative period, typically within 24-48 hours after surgery .Pressure of device between 30-40 mmHg and Cycle time is 10-30 seconds inflation, 10-30 seconds deflation. Therapist will Monitor patients for pain and discomfort during IC therapy, and adjust the protocol as needed. Therapist will Monitor patients' swelling and edema, and adjust the IC therapy protocol to ensure optimal progress. Therapist will Monitor patients' knees functions and adjust the IC therapy protocol to ensure optimal progress. | Combination product | Patients receiving intermittent compression |
Primary outcome
Visual analog scale VAS
Time frame: 12 Months
The 10-point numeric scale ranges from '0' representing "no pain" to '10' representing "pain as bad as you can imagine" or "worst pain imaginable".
Knee injury and osteoarthritis outcome score KOOS
Time frame: 12 Months
The questionnaire has been designed to evaluate Assess the symptoms, function, and quality of life of patients with knee injuries (ACL) or osteoarthritis. There are 5 sections with 42 questions. Each section total score is 100. Each question score between 0-4.Score of 8-10 points is considered clinically significant. Symptoms includes 7 questions which between 0-100. Severe symptoms (0-30), Moderate symptoms (31-60), Mild symptoms (61-100)
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 30 May 2025.
- Individual participant dataSharing planned: No
Related trials for Anterior Cruciate Ligament Injuries
Not yet recruiting
Clinical and Biological Outcomes of BioBrace-Augmented ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
Not yet recruiting
Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Postoperative Recovery Quality in Patients Undergoing Anterior Cruciate Ligament Reconstruction
Anterior Cruciate Ligament Injuries, Recovery Quality
Not yet recruitingPhase 3
Extended Post-Operative Oral Tranexamic Acid Dosing After ACL Reconstruction
Anterior Cruciate Ligament Injuries, Anterior Cruciate Ligament Rupture
RecruitingObservational study
BioBrace® Augmentation in Anterior Cruciate Ligament Reconstruction Procedures
ACL Tears
RecruitingObservational study
Evaluation of the Correlation Between Bone Tunnel Projection Placement and Clinical Outcomes in Anterior Cruciate Ligament Reconstruction Surgery
Anterior Cruciate Ligament Injury, Tunneling Technique
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 Patients receiving CPM and Patients receiving intermittent compression 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 5 inclusion and 5 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 30 May 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?
Visual analog scale VAS (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 30 May 2025.