The Effect of Functional Electrical Stimulation

Rupture of Anterior Cruciate Ligament Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02817399
• Other study ID #: 16022015
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: January 2018

Study information

• Verified date: January 2018
• Source: Medical Corps, Israel Defense Force
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: January 2018
• Est. primary completion date: January 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

• 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

Related Conditions & MeSH terms

• Rupture
• Rupture of Anterior Cruciate Ligament

Intervention

Device:
• Functional electrical stimulation
Electrical stimulation that cause muscle contraction while walking
• 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

Locations

Country	Name	City	State
Israel	Zrifin	Rishon LeZion	Doar Tsvai

Sponsors (2)

Lead Sponsor	Collaborator
Medical Corps, Israel Defense Force	Ariel University

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Gait speed	Measured by kilometer per hour	One year
Secondary	Step length	Measured by length of the average step for each leg	One year
Secondary	Quadriceps strength	Measured by maximal peak torque in each leg (through Biodex Isokinetic dynamometer)	One year