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The Effect of Functional Electrical Stimulation

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02817399
Enrollment
23
Registered
2016-06-29
Start date
2016-01-31
Completion date
2018-01-31
Last updated
2022-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rupture of Anterior Cruciate Ligament

Keywords

anterior cruciate ligament reconstruction, Functional Electrical stimulation, Gait analysis, Physical therapy

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.

Interventions

DEVICEFunctional electrical stimulation

Electrical stimulation that cause muscle contraction while walking

DEVICENeuro-muscular electrical stimulation

Electrical stimulation that cause muscle contraction in a stationary position

Subjects will receive training exercise according to ACL reconstruction protocol

Sponsors

Ariel University
CollaboratorOTHER
Medical Corps, Israel Defense Force
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Percentages of single support at each legOne yearThe 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

MeasureTime frameDescription
strength symmetryOne yearThe method of assessment for this Outcome Measure is by calculated the differences between the right Quadriceps strength and the left Quadriceps strength
Gait speedOne yearMeasured by kilometer per hour
Step lengthOne yearMeasured by length of the average step for each leg
Quadriceps strengthOne yearMeasured by maximal peak torque in each leg (through Biodex Isokinetic dynamometer)

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026