This trial is active, not recruiting.

Condition rupture of anterior cruciate ligament
Treatments functional electrical stimulation, neuro-muscular electrical stimulation, active exercises
Sponsor Medical Corps, Israel Defense Force
Collaborator Ariel University
Start date January 2016
End date March 2017
Trial size 56 participants
Trial identifier NCT02817399, 16022015


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (investigator, outcomes assessor)
Primary purpose treatment
(Active Comparator)
Active exercises & Neuro-muscular electrical stimulation in a stationary position (lying and/or sitting).
neuro-muscular electrical stimulation
Electrical stimulation that cause muscle contraction in a stationary position
active exercises
Subjects will receive training exercise according to ACL reconstruction protocol
Active exercises & Functional electrical stimulation while walking.
functional electrical stimulation
Electrical stimulation that cause muscle contraction while walking
active exercises
Subjects will receive training exercise according to ACL reconstruction protocol

Primary Outcomes

Percentages of single support at each leg
time frame: One year

Secondary Outcomes

strength symmetry
time frame: One year
Gait speed
time frame: One year
Step length
time frame: One year
Quadriceps strength
time frame: One year

Eligibility Criteria

Male or female participants from 18 years up to 30 years old.

- 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

Additional Information

Official title The Effect of Functional Electrical Stimulation on Gait Quality After Anterior Cruciate Ligament Reconstruction
Principal investigator Shmuel Springer, Ph.d
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Medical Corps, Israel Defense Force.