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

Sponsor
University of Sao Paulo (Other)
Overall Status
Completed
CT.gov ID
NCT01821599
Collaborator
(none)
29
1
2
26.9
1.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Nonaccelerated Rehabilitation
  • Other: Accelerated Rehabilitation
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
29 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Comparative Study Between Two Physiotherapy Protocols Conventional X Accelerated in Individuals Undergoing Reconstruction of the Anterior Cruciate Ligament.
Study Start Date :
Jan 1, 2013
Actual Primary Completion Date :
Mar 1, 2015
Actual Study Completion Date :
Apr 1, 2015

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. KT1000 measures [Sixth months]

    Measure of anterior knee stability

Secondary Outcome Measures

  1. International Knee Documentation Committee (IKDC 2000) [Sixth months]

    Questionnaire function subjective of the knee

  2. Hop Test measures [sixth months]

    Jump with one leg

  3. Isokinetic of the knee measures [sixth months]

    Knee Muscle Strength (Cybex).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Institute of Orthopedics and Traumatology, Faculty of Medicine of São Paulo São Paulo Brazil 03403-010

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
José Carlos Alves Fabrício Júnior, Specialist, Master Student, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01821599
Other Study ID Numbers:
  • LCA-9090
First Posted:
Apr 1, 2013
Last Update Posted:
Apr 14, 2015
Last Verified:
Dec 1, 2014
Keywords provided by José Carlos Alves Fabrício Júnior, Specialist, Master Student, University of Sao Paulo

Study Results

No Results Posted as of Apr 14, 2015