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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by University of Sao Paulo
Sponsor:
Information provided by (Responsible Party):
José Carlos Alves Fabrício Júnior, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01821599
First received: March 20, 2013
Last updated: October 15, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Rehabilitation Accelerated
Anterior Cruciate Ligament Reconstruction
Other: Nonaccelerated Rehabilitation
Other: Accelerated Rehabilitation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Recovery time after ACL reconstruction. [ Time Frame: Until sixth months. ] [ Designated as safety issue: No ]

Estimated Enrollment: 32
Study Start Date: January 2013
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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 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)
  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01821599

Contacts
Contact: JOSE CARLOS C Fabrício, Master student (011) 982381808 fabriciojr_fisio@hotmail.com

Locations
Brazil
Institute of Orthopedics and Traumatology, Faculty of Medicine of São Paulo Recruiting
São Paulo, Brazil, 03403-010
Contact: Roberto Mota    011 30792695    rmotaa@uol.com.br   
Principal Investigator: Jose Carlos Fabricio         
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: José Carlos Fabrício University of Sao Paulo
Study Director: Roberto Mota University of Sao Paulo
  More Information

No publications provided

Responsible Party: José Carlos Alves Fabrício Júnior, Specialist, Master Student, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01821599     History of Changes
Other Study ID Numbers: LCA-9090
Study First Received: March 20, 2013
Last Updated: October 15, 2013
Health Authority: Universidade de São Paulo, Brazil ':'

Keywords provided by University of Sao Paulo:
Anterior Cruciate Ligament
Reconstruction
Rehabilitation

ClinicalTrials.gov processed this record on September 16, 2014