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Electrostimulation in Anterior Cruciate Ligament Reconstruction

Primary Purpose

Knee Injuries

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
electrical stimulation
physical therapy exercises
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Injuries focused on measuring Anterior Cruciate Ligament, Electric Stimulation Therapy

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Universidade Federal de São Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Electrical stimulation

Physical therapy exercises

Arm Description

The subjects on this group will be submitted to a conventional rehabilitation (ROM increase, strength recovery, functional training) associated with electrostimulation.

The subjects on this group will be submitted to a conventional rehabilitation (ROM increase, strength recovery, functional training).

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 3, 2012
Last Updated
July 16, 2015
Sponsor
Federal University of São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01633047
Brief Title
Electrostimulation in Anterior Cruciate Ligament Reconstruction
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
Participants Twenty-two patients that submitted to ACL surgical reconstruction with flexor grafts less than 15 days previously will be included in the study, both genders, between 18-45 years old. Individuals with previous knee lesions, other ligament injuries, osteochondritis or associated menisci repair and complications during surgery will not be included in the study. Patients that carried out complimentary therapies to the proposed treatment will be excluded. The participants will be randomized into two groups: control and electrical stimulation group . Intervention All the subjects will be submitted to physiotherapy sessions three times a week, following a 12 weeks criterion based reahabilitation, carried out in line with the objectives proposed for each rehabilitation phase (immediate post-operative, early post-operativeand late post-operative). A group of trained physiotherapists will design the exercises and determinate their evolution, including range of motion improvement, muscular control and strength, gait training with progression in weight bearing and sensory-motor control training, according to the established guidelines. The patients from the electrical stimulation group will receive, in addition, NMES application in the first six weeks of treatment, using an electrical stimulator with a carrier frequency of 47 Hz with symmetrical, biphasic and pyramidal waves, with pulse duration of 150 µs and duty cycle of 1,5 sec on and 1,8 sec off. Evaluation 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Injuries
Keywords
Anterior Cruciate Ligament, Electric Stimulation Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Electrical stimulation
Arm Type
Experimental
Arm Description
The subjects on this group will be submitted to a conventional rehabilitation (ROM increase, strength recovery, functional training) associated with electrostimulation.
Arm Title
Physical therapy exercises
Arm Type
Active Comparator
Arm Description
The subjects on this group will be submitted to a conventional rehabilitation (ROM increase, strength recovery, functional training).
Intervention Type
Other
Intervention Name(s)
electrical stimulation
Intervention Description
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)
Intervention Type
Other
Intervention Name(s)
physical therapy exercises
Intervention Description
Control group that will be submitted only to physical therapy exercises

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tiago A Bozzo
Organizational Affiliation
Federal University of São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidade Federal de São Paulo
City
São Paulo
State/Province
SP
ZIP/Postal Code
04039-001
Country
Brazil

12. IPD Sharing Statement

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Electrostimulation in Anterior Cruciate Ligament Reconstruction

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