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Active, Not Recruiting

NCT Number: NCT06997679

Effects of Continuous Passive Movements vs 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Wounds and Injuries

Age range

20 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shalamar Hospital

Lahore, Pakistan

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Patients receiving CPM

Diagnostic 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 compression

Combination 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.

Primary outcomes

  1. 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".

  2. 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)

Sponsors and collaborators

Lead sponsor

Superior University

Other

Registry information

Official study title

Effects of Continuous Passive Movements Versus Intermittent Compression in Patients With Post ACL Reconstruction Surgery

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
May 30, 2025
Registry last updated
May 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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