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

NCT ID: NCT06997679

Last Updated: 2025-05-30

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-25
• Study Completion Date: 2026-02-01

Brief 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 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).

Conditions

Anterior Cruciate Ligament Injuries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Patients receiving CPM

Group Type: EXPERIMENTAL

Patients receiving CPM

Intervention Type: 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

Group Type: ACTIVE_COMPARATOR

Patients receiving intermittent compression

Intervention Type: 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.

Interventions

Patients receiving CPM

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

Intervention Type: DIAGNOSTIC_TEST

Patients receiving intermittent compression

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.

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Superior University

OTHER

Sponsor Role: lead

Responsible Party

Muhammad Naveed Babur

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shalamar Hospital

Lahore, , Pakistan

Countries

Pakistan

Other Identifiers

MSRSW/Batch-Fall23/825

Identifier Type: -

Identifier Source: org_study_id