NCT06997679

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 25, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 30, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

May 30, 2025

Status Verified

May 1, 2025

Enrollment Period

4 months

First QC Date

May 21, 2025

Last Update Submit

May 21, 2025

Conditions

Anterior Cruciate Ligament Injuries

Outcome Measures

Primary Outcomes (2)

  • 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".

    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)

    12 Months

Study Arms (2)

Patients receiving CPM

EXPERIMENTAL
Diagnostic Test: Patients receiving CPM

Patients receiving intermittent compression

ACTIVE COMPARATOR
Combination Product: Patients receiving intermittent compression

Interventions

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 CPM
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.

Patients receiving intermittent compression

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shalamar Hospital

Lahore, Pakistan

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 21, 2025

First Posted

May 30, 2025

Study Start

February 25, 2025

Primary Completion

July 1, 2025

Study Completion

February 1, 2026

Last Updated

May 30, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)