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The Effect of Functional Electrical Stimulation

Primary Purpose

Rupture of Anterior Cruciate Ligament

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Functional electrical stimulation
Neuro-muscular electrical stimulation
Active exercises
Sponsored by
Medical Corps, Israel Defense Force
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rupture of Anterior Cruciate Ligament focused on measuring anterior cruciate ligament reconstruction, Functional Electrical stimulation, Gait analysis, Physical therapy

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesDoes not accept healthy volunteers

  • 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

Sites / Locations

  • Zrifin

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Neuro-muscular electrical stimulation

Functional electrical stimulation

Arm Description

Active exercises & Neuro-muscular electrical stimulation in a stationary position (lying and/or sitting).

Active exercises & Functional electrical stimulation while walking.

Outcomes

Primary Outcome Measures

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%).

Secondary Outcome Measures

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
Gait speed
Measured by kilometer per hour
Step length
Measured by length of the average step for each leg
Quadriceps strength
Measured by maximal peak torque in each leg (through Biodex Isokinetic dynamometer)

Full Information

First Posted
March 15, 2016
Last Updated
December 12, 2022
Sponsor
Medical Corps, Israel Defense Force
Collaborators
Ariel University
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1. Study Identification

Unique Protocol Identification Number
NCT02817399
Brief Title
The Effect of Functional Electrical Stimulation
Official Title
The Effect of Functional Electrical Stimulation on Gait Quality After Anterior Cruciate Ligament Reconstruction
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
January 1, 2018 (Actual)
Study Completion Date
January 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical Corps, Israel Defense Force
Collaborators
Ariel University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rupture of Anterior Cruciate Ligament
Keywords
anterior cruciate ligament reconstruction, Functional Electrical stimulation, Gait analysis, Physical therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neuro-muscular electrical stimulation
Arm Type
Active Comparator
Arm Description
Active exercises & Neuro-muscular electrical stimulation in a stationary position (lying and/or sitting).
Arm Title
Functional electrical stimulation
Arm Type
Experimental
Arm Description
Active exercises & Functional electrical stimulation while walking.
Intervention Type
Device
Intervention Name(s)
Functional electrical stimulation
Intervention Description
Electrical stimulation that cause muscle contraction while walking
Intervention Type
Device
Intervention Name(s)
Neuro-muscular electrical stimulation
Intervention Description
Electrical stimulation that cause muscle contraction in a stationary position
Intervention Type
Procedure
Intervention Name(s)
Active exercises
Intervention Description
Subjects will receive training exercise according to ACL reconstruction protocol
Primary Outcome Measure Information:
Title
Percentages of single support at each leg
Description
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%).
Time Frame
One year
Secondary Outcome Measure Information:
Title
strength symmetry
Description
The method of assessment for this Outcome Measure is by calculated the differences between the right Quadriceps strength and the left Quadriceps strength
Time Frame
One year
Title
Gait speed
Description
Measured by kilometer per hour
Time Frame
One year
Title
Step length
Description
Measured by length of the average step for each leg
Time Frame
One year
Title
Quadriceps strength
Description
Measured by maximal peak torque in each leg (through Biodex Isokinetic dynamometer)
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shmuel Springer, Ph.d
Organizational Affiliation
Physiotherapy department, school of Health Sciences, Ariel University, ISRAEL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zrifin
City
Rishon LeZion
State/Province
Doar Tsvai
ZIP/Postal Code
03529
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Functional Electrical Stimulation

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