NCT01633047

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 3, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 4, 2012

Completed
2.9 years until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

July 20, 2015

Status Verified

July 1, 2015

Enrollment Period

1 month

First QC Date

July 3, 2012

Last Update Submit

July 16, 2015

Conditions

Knee Injuries

Keywords

Anterior Cruciate LigamentElectric Stimulation Therapy

Study Arms (2)

Electrical stimulation

EXPERIMENTAL

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

Other: electrical stimulationOther: physical therapy exercises

Physical therapy exercises

ACTIVE COMPARATOR

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

Other: physical therapy exercises

Interventions

electrical stimulationOTHER

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)

Electrical stimulation
physical therapy exercisesOTHER

Control group that will be submitted only to physical therapy exercises

Electrical stimulationPhysical therapy exercises

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal de São Paulo

São Paulo, São Paulo, 04039-001, Brazil

Location

MeSH Terms

Conditions

Knee Injuries

Interventions

Electric StimulationExercise Therapy

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Physical StimulationInvestigative TechniquesRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Officials

  • Tiago A Bozzo

    Federal University of São Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

July 3, 2012

First Posted

July 4, 2012

Study Start

June 1, 2015

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

July 20, 2015

Record last verified: 2015-07

Locations

BR(1)