The Effect of Functional Electrical Stimulation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effect of Functional Electrical Stimulation on Gait Quality After Anterior Cruciate Ligament Reconstruction

Conditions
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Rupture of Anterior Cruciate Ligament

Intervention / Treatment
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* Device: Functional electrical stimulation
* Device: Neuro-muscular electrical stimulation
* Procedure: Active exercises


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Neuro-muscular electrical stimulation<br>Active exercises & Neuro-muscular electrical stimulation in a stationary position (lying and/or sitting). | Device: Neuro-muscular electrical stimulation<br>* Electrical stimulation that cause muscle contraction in a stationary position<br>Procedure: Active exercises<br>* Subjects will receive training exercise according to ACL reconstruction protocol<br>|
| Experimental: Functional electrical stimulation<br>Active exercises & Functional electrical stimulation while walking. | Device: Functional electrical stimulation<br>* Electrical stimulation that cause muscle contraction while walking<br>Procedure: Active exercises<br>* Subjects will receive training exercise according to ACL reconstruction protocol<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentages of single support at each leg | The test will perform with the Optogait system (a device for the Gait Analysis). Single support phase within the gait cycle during which the body mass is carried by a single limb. This parameter calculated by percentage of stride (normally about 40%). | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| strength symmetry | The method of assessment for this Outcome Measure is by calculated the differences between the right Quadriceps strength and the left Quadriceps strength | One year | 
| Gait speed | Measured by kilometer per hour | One year | 
| Step length | Measured by length of the average step for each leg | One year | 
| Quadriceps strength | Measured by maximal peak torque in each leg (through Biodex Isokinetic dynamometer) | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anterior cruciate ligament reconstruction, Functional Electrical stimulation, Gait analysis, Physical therapy