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

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Conditions studied: Spinal Cord Injury, Paraplegia, Spasticity, Neurorehabilitation

In brief

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.

Key facts

Study ID

NCT07583576

Run by

Istanbul Medipol University Hospital

People needed

40

Starts

2026-05-10

Expected to finish

2026-07-10

Last updated by the study team

2026-05-19

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Severe lower extremity contractures or deformities limiting movement
• 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

Full record on ClinicalTrials.gov

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