The Effect of Functional Electrical Stimulation

Medical Corps, Israel Defense Force

Status: Completed

Conditions: Rupture of Anterior Cruciate Ligament

Treatments: Procedure: Active exercises; Device: Functional electrical stimulation; Device: Neuro-muscular electrical stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02817399

16022015

Details and patient eligibility

About

The purpose of this study is to examine the short term effect of functional electrical stimulation treatment versus neuro-muscular electrical stimulation on gait quality for patient after anterior cruciate ligament reconstruction.

Full description

Background: Quadriceps weakness is common following anterior cruciate ligament (ACL) reconstruction. The inadequate quadriceps strength contributes to altered gait patterns following ACL reconstruction. Neuromuscular electrical stimulation (NMES) has been shown to reduce quadriceps atrophy post-ACL reconstruction. However, the effect of functional electrical stimulation (FES), a modulation of NMES which enables quadriceps stimulation synchronized with gait, has not been tested.

Objective: The aim of this study is to evaluate the effectiveness of FES to improve the gait pattern of patients post ACL reconstruction.

Methods: Fifty six Individuals post-ACL reconstruction will be randomly placed into FES or NMES treatment group. All patients will receive a standard exercise program three sessions weekly. In addition, each group will receive a different electrical stimulation treatment: Neuromuscular Electrical Stimulation (NMES) or Functional Electrical Stimulation (FES). Outcome measures will include spatiotemporal gait measures (e.g., gait speed, single limb support, and asymmetry index), as well as isometric quadriceps strength. Measures will be taken a week before the surgery, a week after it, and one month from the beginning of rehabilitation. Strength and gait pattern will be measured. Isometric Quadriceps strength will measured using the Biodex isokinetic system, and gait analysis will be carried out through the spatio-temporal Optogait system.

Enrollment: 23 patients

Sex: All

Ages: 18 to 30 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• Inclusion Criteria:

  • Intended patients for ACL reconstruction procedure
  • Age 18-30
  • Committed for three sessions per week for 4 weeks

• Exclusion Criteria:

  • Previous surgery at the same knee
  • Chronic knee swelling
  • Knee injury
  • History of recurrent ankle sprains, Achilles tendinopathy, or lower limb

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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23 participants in 2 patient groups

Neuro-muscular electrical stimulation

Active Comparator group

Description:

Active exercises \& Neuro-muscular electrical stimulation in a stationary position (lying and/or sitting).

Treatment:

Procedure: Active exercises

Device: Neuro-muscular electrical stimulation

Functional electrical stimulation

Experimental group

Description:

Active exercises \& Functional electrical stimulation while walking.

Treatment:

Procedure: Active exercises

Device: Functional electrical stimulation