Trial record 18 of 27 for:    Open Studies | "Anterior Cruciate Ligament Reconstruction"

Effects of Low Frequency Neuromuscular Electrical Stimulation Applied to the Quadriceps in the Production of Knee Extension Strength and Control of Edema After Anterior Cruciate Ligament Reconstruction

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Federal University of São Paulo.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01633047
First received: July 3, 2012
Last updated: July 9, 2012
Last verified: June 2012
  Purpose

The anterior cruciate ligament (ACL) is frequently injured, and it is the structure of the athlete´s knee which has the highest prevalence of reconstruction. Given this postoperative ACL reconstruction scenario the investigator find in literature the effectiveness of neuromuscular electrical stimulation (NMES) as an adjuvant treatment for strengthening the quadriceps muscle. The intensity of NMES and the training duration are important factors for a successful treatment.

The purpose of this study is to compare two rehabilitation protocols in patients during the post operative of the ACL reconstruction over the strength of knee extension and control of edema.

It will be a randomized controlled study with the CONSORT bases with 40 participants that will be divided into two groups: Control group that will be submitted only to physical therapy exercises, and the Intervention group that will be submitted to physical therapy exercises plus electrical stimulation (low frequency device with a current of 47 Hz with symmetrical, biphasic and pyramidal waveforms, with pulse duration of 1.5 s and interval of 1.8 s). The procedure will last six weeks. It will be evaluated the pre intervention quadriceps muscle extension force by means of a manual dynamometer, and the joint swelling through the perimeter. This procedure will be repeated after six weeks of intervention. Results are expressed as hazard ratios (HR) with their respective confidence intervals at 95% and adopting α = 0.05. All analyzes will be performed by SPSS version 17.0


Condition Intervention
Athlete´s Knee
Other: electrical stimulation
Other: physical therapy exercises

Study Type: Interventional

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Arms Assigned Interventions
Experimental: Intervention Other: electrical stimulation
Intervention group that will be submitted to physical therapy exercises plus electrical stimulation (low frequency device with a current of 47 Hz with symmetrical, biphasic and pyramidal waveforms, with pulse duration of 1.5 s and interval of 1.8 s)
Sham Comparator: Control Other: physical therapy exercises
Control group that will be submitted only to physical therapy exercises

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

Inclusion Criteria:

  • Subjects between 18 e 45 years old, submitted in the last 15 days to the ACL reconstruction surgery, being the first knee lesion episode.

Exclusion Criteria:

  • Patients cannot present any constrains regarding the physical activity practice according to the Sports Medicine American College.
  • cartilage degeneration with a degree higher than 2 according to the cartilage Repair International Society
  • Presence of other ligamentary lesions associated to the ACL reconstruction.
  • Utilization of complementary therapies parallel to the treatment.
  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: NCT01633047

Contacts
Contact: Tiago Alves Bozzo 551199098767 tiagobozzo@hotmail.com

Locations
Brazil
Universidade Federal de São Paulo Recruiting
São Paulo, SP, Brazil, 04039-001
Contact: Tiago Alves Bozzo    551199098767    tiagobozzo@hotmail.com   
Sponsors and Collaborators
Federal University of São Paulo
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01633047     History of Changes
Other Study ID Numbers: CAAE 01430812.1.0000.5505
Study First Received: July 3, 2012
Last Updated: July 9, 2012
Health Authority: Brazil: National Committee of Ethics in Research
Brazil: Ministry of Health
Brazil: Ethics Committee

Keywords provided by Federal University of São Paulo:
Anterior Cruciate Ligament
Electric Stimulation Therapy

ClinicalTrials.gov processed this record on August 19, 2014