The Effect of Functional Electrical Stimulation

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

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.

Study Overview

• Status: Completed
• Conditions: Rupture of Anterior Cruciate Ligament
• Intervention / Treatment: Device: Neuro-muscular electrical stimulation; Procedure: Active exercises; Device: Functional electrical stimulation

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.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Doar Tsvai
    • Rishon LeZion, Doar Tsvai, Israel, 03529
      • Zrifin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 26 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Medical Corps, Israel Defense Force
• Collaborators: Ariel University
• Investigators: Principal Investigator: Shmuel Springer, Ph.d, Physiotherapy department, school of Health Sciences, Ariel University, ISRAEL

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): January 1, 2018
• Study Completion (Actual): January 1, 2018

Study Registration Dates

• First Submitted: March 15, 2016
• First Submitted That Met QC Criteria: June 26, 2016
• First Posted (Estimate): June 29, 2016

Study Record Updates

• Last Update Posted (Actual): December 13, 2022
• Last Update Submitted That Met QC Criteria: December 12, 2022
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Physical therapy; Gait analysis; anterior cruciate ligament reconstruction; Functional Electrical stimulation
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture
• Other Study ID Numbers: 16022015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No