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Completed

NCT Number: NCT02817399

The Effect of Functional Electrical Stimulation

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.

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Key information

Conditions

Rupture of Anterior Cruciate Ligament Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Wounds and Injuries

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zrifin

Rishon LeZiyyon, Doar Tsvai, 03529, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

functional electrical stimulation

Device

Electrical stimulation that cause muscle contraction while walking

Neuro-muscular electrical stimulation

Device

Electrical stimulation that cause muscle contraction in a stationary position

Active exercises

Procedure

Subjects will receive training exercise according to ACL reconstruction protocol

Primary outcomes

  1. 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

  1. strength symmetry

    Time frame: 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

  2. Gait speed

    Time frame: One year

    Measured by kilometer per hour

  3. Step length

    Time frame: One year

    Measured by length of the average step for each leg

  4. Quadriceps strength

    Time frame: One year

    Measured by maximal peak torque in each leg (through Biodex Isokinetic dynamometer)

Sponsors and collaborators

Lead sponsor

Medical Corps, Israel Defense Force

Other

Collaborators

  • Ariel University

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jun 29, 2016
Registry last updated
Dec 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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