The Effect of Functional Electrical Stimulation
- Conditions
- Rupture of Anterior Cruciate Ligament
- Interventions
- Device: Functional electrical stimulationDevice: Neuro-muscular electrical stimulationProcedure: Active exercises
- Registration Number
- NCT02817399
- Lead Sponsor
- Medical Corps, Israel Defense Force
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 23
- Intended patients for ACL reconstruction procedure
- Age 18-30
- Committed for three sessions per week for 4 weeks
- Previous surgery at the same knee
- Chronic knee swelling
- Knee injury
- History of recurrent ankle sprains, Achilles tendinopathy, or lower limb
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Neuro-muscular electrical stimulation Active exercises Active exercises \& Neuro-muscular electrical stimulation in a stationary position (lying and/or sitting). Functional electrical stimulation Functional electrical stimulation Active exercises \& Functional electrical stimulation while walking. Functional electrical stimulation Active exercises Active exercises \& Functional electrical stimulation while walking. Neuro-muscular electrical stimulation Neuro-muscular electrical stimulation Active exercises \& Neuro-muscular electrical stimulation in a stationary position (lying and/or sitting).
- Primary Outcome Measures
Name Time Method Percentages of single support at each leg One year 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%).
- Secondary Outcome Measures
Name Time Method Gait speed One year Measured by kilometer per hour
Step length One year Measured by length of the average step for each leg
Quadriceps strength One year Measured by maximal peak torque in each leg (through Biodex Isokinetic dynamometer)
strength symmetry One year The method of assessment for this Outcome Measure is by calculated the differences between the right Quadriceps strength and the left Quadriceps strength
Trial Locations
- Locations (1)
Zrifin
🇮🇱Rishon LeZion, Doar Tsvai, Israel