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

NCT ID: NCT01821599

Last Updated: 2015-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2015-04-30

Brief Summary

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.

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)

Conditions

Rehabilitation; Anterior Cruciate Ligament Reconstruction; Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Conventional group

Nonaccelerated Rehabilitation After Anterior Cruciate Ligament Reconstruction

Group Type: ACTIVE_COMPARATOR

Nonaccelerated Rehabilitation

Intervention Type: OTHER

Nonaccelerated Rehabilitation After Anterior Cruciate Ligament Reconstruction in 6 months of recovery.

Accelerated group

Accelerated Rehabilitation After Anterior Cruciate Ligament Reconstruction

Group Type: EXPERIMENTAL

Accelerated Rehabilitation

Intervention Type: OTHER

Accelerated Rehabilitation After Anterior Cruciate Ligament Reconstruction in 4 months of recovery.

Interventions

Nonaccelerated Rehabilitation

Nonaccelerated Rehabilitation After Anterior Cruciate Ligament Reconstruction in 6 months of recovery.

Intervention Type: OTHER

Accelerated Rehabilitation

Accelerated Rehabilitation After Anterior Cruciate Ligament Reconstruction in 4 months of recovery.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

José Carlos Alves Fabrício Júnior

Specialist, Master Student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

José Carlos Fabrício

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Roberto Mota

Role: STUDY_DIRECTOR

University of Sao Paulo

Locations

Institute of Orthopedics and Traumatology, Faculty of Medicine of São Paulo

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

LCA-9090

Identifier Type: -

Identifier Source: org_study_id