Clinical Trial

Effects of Functional Electrical Stimulation on Spasticity, Quadriceps Muscle Strength and Functional Mobility in Individuals With Paraplegia

Study acronym: FES-PAR-RCT
Not Yet Recruiting
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Record status
This record was last updated May 19, 2026 (before its estimated June 10, 2026 completion). Its status may not reflect the trial's current state.
Summary
Spinal cord injury (SCI)-related paraplegia is a complex neurological condition characterized by motor impairment, increased spasticity, and significant functional limitations in daily activities. Spasticity is one of the most common secondary complications after upper motor neuron lesions and can negatively affect rehabilitation outcomes, gait ability, and functional independence. This randomized controlled study aims to investigate the effects of Functional Electrical Stimulation (FES) applied to the quadriceps muscle in individuals with paraplegia. Participants will be randomly assigned to either a control group receiving conventional neurorehabilitation or an intervention group receiving additional FES treatment. The primary outcomes include changes in spasticity level, quadriceps muscle strength, and functional mobility. Spasticity will be assessed using the Modified Ashworth Scale (MAS), muscle strength will be evaluated with Manual Muscle Testing (MMT), and functional mobility will be measured using the Spinal Cord Independence Measure (SCIM), Timed Up and Go Test (TUG), and 6-Minute Walk Test (6MWT). The intervention period will last 8 weeks, with standardized rehabilitation programs applied to both groups. The FES group will additionally receive quadriceps stimulation with specific neuromuscular electrical stimulation parameters. The findings of this study are expected to provide evidence regarding the effectiveness of FES as an adjunct to conventional rehabilitation in improving motor function and functional independence in individuals with paraplegia.
Protocol Amendment History 1 change
notable Enrollment reduced: 60 -> 40 participants 2026-05-20
Trial Details
NCT Number NCT07583576
Lead Sponsor Istanbul Medipol University Hospital
Conditions Spinal Cord Injury, Paraplegia, Spasticity, Neurorehabilitation
Enrollment 40 participants
Start Date 2026-05-10
Primary Completion 2026-06-10 (estimated)
Study Completion 2026-07-10 (estimated)
Updated on ClinicalTrials.gov 2026-05-19