Comparative Study Between Two Physiotherapy Protocols Conventional X Accelerated in Individuals Undergoing Reconstruction of the Anterior Cruciate Ligament.

The accelerated rehabilitation and early return does not seem to be harmful, but still needs further research to define the rehabilitation time is what shows Kruse and collaborators (2012) in their study of systematic review. The surgical treatment of anterior cruciate ligament injury is the gold standard in the treatment of these injuries in young and active, the postoperative rehabilitation is extensive and full return to sport occurs only after 6 months postoperatively. Based on this gap, the investigators seek to draw properly through our study methods and more complex techniques, that comparing two rehabilitation programs can achieve high precision early rehabilitation. This will include 32 athletes who had complete ACL rupture confirmed by MRI and underwent ACL reconstruction using patellar tendon.All subjects will be followed from the pre-surgery, the fourth and sixth month after surgery with: KT1000 measures the ligamentous laxity, knee function by applying the International Knee Documentation Committee (IKDC 2000); Isokinetic Muscle Strength (Cybex). Through a random draw of sealed envelopes, patients will be allocated in their rehabilitation groups: Accelerated (4 months) or Conventional (6 months). Preoperatively, fourth and sixth month after surgery will be an assessment of laxity by (KT1000), Muscular Strength (CYBEX) and knee function affected by IKDC (2000) and Hop Test. The assessor and the patients were blinded to treatment group. This study will have the locus Institute of Orthopaedics and Traumatology, School of Medicine, São Paulo. The comparative results of the two groups are analyzed using specific statistical tests to prove an improved significative without damaging the integrity of the graft.

Study Overview

• Status: Completed
• Conditions: Anterior Cruciate Ligament Reconstruction; Rehabilitation; Knee
• Intervention / Treatment: Other: Nonaccelerated Rehabilitation; Other: Accelerated Rehabilitation

Detailed Description

All subjects will be followed for a period of six months. During this period will undergo three stages of evaluation.

1. º Preoperative up to two years following injury : assessment will consist KT1000 measures the ligamentous laxity, knee function by applying the International Knee Documentation Committee (IKDC 2000); Hop Test (jumps with one leg); Isokinetic Muscle Strength (Cybex).
2. º 4º months pós-surgery KT1000, International Knee Documentation Committee (IKDC 2000); Hop Test; Isokinetic Muscle Strength (Cybex)
3. º 6º months postoperatively KT1000, International Knee Documentation Committee (IKDC) + Hop Test; Isokinetic Muscle Strength (Cybex)

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 03403-010
    • Institute of Orthopedics and Traumatology, Faculty of Medicine of São Paulo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• With diagnosis of injury (primary) anterior cruciate ligament confirmed by magnetic resonance may or may not be associated with a meniscal injury or partial ligament medial collateral ligament (MCL) surgery is not indicated.
• Patients undergo surgery for anterior cruciate ligament reconstruction using patellar tendon.

Exclusion Criteria:

• Patients who had changes in diagnosis during surgery.
• Surgical complications
• Patients with More than 30% of lack or abandon physiotherapy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional group; Nonaccelerated Rehabilitation After Anterior Cruciate Ligament Reconstruction	Other: Nonaccelerated Rehabilitation; Nonaccelerated Rehabilitation After Anterior Cruciate Ligament Reconstruction in 6 months of recovery.
Experimental: Accelerated group; Accelerated Rehabilitation After Anterior Cruciate Ligament Reconstruction	Other: Accelerated Rehabilitation; Accelerated Rehabilitation After Anterior Cruciate Ligament Reconstruction in 4 months of recovery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
KT1000 measures	Measure of anterior knee stability	Sixth months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
International Knee Documentation Committee (IKDC 2000)	Questionnaire function subjective of the knee	Sixth months
Hop Test measures	Jump with one leg	sixth months
Isokinetic of the knee measures	Knee Muscle Strength (Cybex).	sixth months

Collaborators and Investigators

• Sponsor: University of Sao Paulo
• Investigators: Principal Investigator: José Carlos Fabrício, University of Sao Paulo; Study Director: Roberto Mota, University of Sao Paulo

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: March 20, 2013
• First Submitted That Met QC Criteria: March 26, 2013
• First Posted (Estimate): April 1, 2013

Study Record Updates

• Last Update Posted (Estimate): April 14, 2015
• Last Update Submitted That Met QC Criteria: April 12, 2015
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Rehabilitation; Anterior Cruciate Ligament; Knee
• Other Study ID Numbers: LCA-9090