Effects of Functional Electrical Stimulation on Spasticity, Quadriceps Muscle Strength and Functional Mobility in Individuals With Paraplegia
Megadott ok: The study was discontinued due to the relocation of the investigator responsible for its conduct and related logistical constraints.
A vizsgálat adatai
- Ki végzi
- Istanbul Medipol University Hospital
- Azonosító
- NCT07583576
- A regiszteradat frissítve
- 2026. október 28.
- Eredeti leírás
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.A teljes eredeti leírásKevesebb
Effects of Functional Electrical Stimulation on Spasticity, Quadriceps Muscle Strength and Functional Mobility in Individuals With Paraplegia: A Randomized Controlled Trial
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. Brief Summary
This randomized controlled trial aims to investigate the effects of Functional Electrical Stimulation (FES) applied to the quadriceps muscle in individuals with paraplegia. Individuals included in the study will be divided into three groups: control group, FES application group, and Sham group. The control group will receive only a standard neurological rehabilitation program, while the FES group will receive Functional Electrical Stimulation to the quadriceps muscle in addition to the FES program. The Sham FES group will receive Conventional neurorehabilitation + sham/placebo FES.
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.
Bevonási feltételek: Participants will be included in the study if they meet all of the following criteria:; Aged between 18 and 65 years; Diagnosed with spinal cord injury resulting in paraplegia (traumatic or non-traumatic etiology); Classified as ASIA Impairment Scale C or D; Medically stable condition; Presence of lower extremity spasticity (Modified Ashworth Scale ≥ 1); Ability to understand and follow simple instructions; Willingness to participate and provide informed consent.
Kizáró feltételek: Participants will be excluded if they present any of the following conditions:; Presence of cardiac pacemaker or implanted electrical device; Severe cognitive impairment or communication difficulties preventing participation; Active infection or systemic inflammatory condition; Dermatological conditions or open wounds preventing FES application; History of severe autonomic dysreflexia triggered by electrical stimulation; Uncontrolled medical conditions that may interfere with participation or safety; Severe lower extremity contractures or deformities limiting movement.