Effects of Functional Electrical Stimulation on Spasticity, Quadriceps Muscle Strength and Functional Mobility in Individuals With Paraplegia: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
研究概览
简要总结
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.
详细描述
Spinal cord injury (SCI) is a major cause of long-term disability worldwide, often resulting in paraplegia when the thoracic, lumbar, or sacral spinal segments are affected. Individuals with paraplegia commonly experience significant impairments in voluntary motor control, muscle weakness, spasticity, and reduced functional mobility, all of which contribute to decreased independence in activities of daily living.
Spasticity, defined as a velocity-dependent increase in muscle tone due to hyperexcitability of the stretch reflex, is one of the most frequent complications following upper motor neuron lesions. Although spasticity may occasionally contribute to functional stability, excessive spasticity often interferes with voluntary movement, gait training, and rehabilitation outcomes (Pandyan et al., 2005).
Functional Electrical Stimulation (FES) is a neurorehabilitation technique that delivers electrical impulses to peripheral nerves to evoke functional muscle contractions. It facilitates neuromuscular re-education, enhances motor unit recruitment, and may promote neuroplasticity in the central nervous system. Previous studies have demonstrated that FES can improve muscle strength, walking ability, and functional independence in individuals with neurological impairments (Sheffler & Chae, 2007; Kesar et al., 2010; Hesse et al., 2003).
This study is designed as a prospective, single-center, parallel-group, randomized controlled trial conducted in accordance with CONSORT 2010 guidelines. A total of 60 participants with paraplegia secondary to spinal cord injury will be enrolled and randomly allocated into two groups:
Control Group: Standard neurorehabilitation program only Intervention Group: Standard neurorehabilitation program + FES applied to the quadriceps femoris muscle The rehabilitation program will be conducted 3 days per week for 8 weeks and will include stretching exercises, strengthening exercises, balance training, and transfer training. In the intervention group, FES will be applied 5 days per week for 8 weeks with the following parameters: 35 Hz frequency, 300 µs pulse duration, and 10 seconds on / 20 seconds off cycle.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessors will be blinded to group allocation to reduce assessment bias. Participants and care providers will not be blinded due to the nature of the intervention (FES application).
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Control Group - Conventional Rehabilitation
Participants in this arm will receive a standard neurorehabilitation program for paraplegia secondary to spinal cord injury. The program will include stretching exercises, progressive strengthening exercises, balance training, and transfer training. Sessions will be conducted 3 days per week, 45-60 minutes per session, for a total duration of 8 weeks. No Functional Electrical Stimulation (FES) will be applied in this group.
干预措施: Conventional Neurorehabilitation (Other)
FES + Conventional Rehabilitation Group
Participants in this arm will receive the same standard neurorehabilitation program as the control group, including stretching, strengthening, balance, and transfer training (3 days per week, 45-60 minutes per session for 8 weeks). In addition, Functional Electrical Stimulation (FES) will be applied to the quadriceps femoris muscle. FES parameters will include 35 Hz frequency, 300 µs pulse duration, and a 10-second on / 20-second off cycle. FES will be administered 5 days per week for 8 weeks to facilitate neuromuscular activation, improve muscle strength, and reduce spasticity.
干预措施: Functional Electrical Stimulation (FES) of Quadriceps Muscle (Device)
研究者
salih tan
Istanbul Medipol University
Istanbul Medipol University Hospital