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

NCT01821599 | Completed DMC

• 1 other identifier: LCA-9090
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Rehabilitation; Anterior Cruciate Ligament Reconstruction; Knee

Keywords

Anterior Cruciate Ligament; Knee; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• KT1000 measures

  Measure of anterior knee stability

  Sixth months

Secondary Outcomes (3)

• International Knee Documentation Committee (IKDC 2000)

  Sixth months

• Hop Test measures

  sixth months

• Isokinetic of the knee measures

  sixth months

Study Arms (2)

Conventional group

ACTIVE COMPARATOR

Nonaccelerated Rehabilitation After Anterior Cruciate Ligament Reconstruction

Other: Nonaccelerated Rehabilitation

Accelerated group

EXPERIMENTAL

Accelerated Rehabilitation After Anterior Cruciate Ligament Reconstruction

Other: Accelerated Rehabilitation

Interventions

Nonaccelerated Rehabilitation OTHER

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

Conventional group

Accelerated Rehabilitation OTHER

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

Accelerated group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

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

São Paulo, São Paulo, 03403-010, Brazil

Location

Study Officials

• José Carlos Fabrício

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

• Roberto Mota

  University of Sao Paulo

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist, Master Student

Study Record Dates

• First Submitted: March 20, 2013
• First Posted: April 1, 2013
• Study Start: January 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: April 1, 2015
• Last Updated: April 14, 2015

Record last verified: 2014-12

Locations

BR (1)