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Clinical Trials/NCT02817399
NCT02817399
Completed
N/A

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

Medical Corps, Israel Defense Force1 site in 1 country23 target enrollmentJanuary 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Rupture of Anterior Cruciate Ligament
Sponsor
Medical Corps, Israel Defense Force
Enrollment
23
Locations
1
Primary Endpoint
Percentages of single support at each leg
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2016
End Date
January 2018
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Medical Corps, Israel Defense Force
Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

Percentages of single support at each leg

Time Frame: 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 Outcomes

  • Gait speed(One year)
  • Step length(One year)
  • Quadriceps strength(One year)
  • strength symmetry(One year)

Study Sites (1)

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