Clinical trial NCT02817399: 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
Overall status: COMPLETED
Phase: NA
Conditions: Rupture of Anterior Cruciate Ligament
Keywords: anterior cruciate ligament reconstruction
Functional Electrical stimulation
Gait analysis
Physical therapy
Lead sponsor: Medical Corps, Israel Defense Force
Sponsor class: OTHER
Collaborators: name: Ariel University
First posted: 2016-06-29
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percentages of single support at each leg
timeFrame: One year
Secondary outcomes:
measure: strength symmetry
timeFrame: One year
measure: Gait speed
timeFrame: One year
measure: Step length
timeFrame: One year
measure: Quadriceps strength
timeFrame: One year
Other outcomes:
Locations:
city: Rishon LeZion
country: Israel
facility: Zrifin
state: Doar Tsvai
Study officials:
affiliation: Physiotherapy department, school of Health Sciences, Ariel University, ISRAEL
name: Shmuel Springer, Ph.d
role: PRINCIPAL_INVESTIGATOR
References: