The Effect of Subthreshold Electrical Stimulation on Spasticity and Functionality in Patients With Spastic Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Ankle Dorsiflexion Range of Motion
研究概览
简要总结
This study investigates whether adding sensory-level electrical stimulation to an ongoing neurodevelopmental treatment program is associated with changes in ankle mobility, spasticity-related measures, muscle mechanical properties, and functional performance in children with spastic cerebral palsy. Children complete a 12-week rehabilitation program and are assessed at baseline, after 6 weeks of neurodevelopmental treatment alone, and after an additional 6 weeks during which sensory-level electrical stimulation is added to the ongoing treatment. The study aims to determine the feasibility of this combined approach and to explore whether favorable changes occur over time in range of motion and functional outcomes.
详细描述
This study is a single-arm, sequential, repeated-measures investigation conducted in children with spastic cerebral palsy. The purpose is to examine biomechanical and functional changes associated with adding sensory-level electrical stimulation to an individualized neurodevelopmental treatment program.
All participants complete a 12-week rehabilitation program with assessments at three time points: baseline (week 0), after Phase 1 (week 6), and after Phase 2 (week 12). During Phase 1, participants receive individualized neurodevelopmental treatment as routine care, 2 days per week for 60 minutes per session. During Phase 2, sensory-level electrical stimulation is added as an adjunct to the ongoing neurodevelopmental treatment and is delivered 3 times per week for 30 minutes per session. Sensory-level stimulation is applied without eliciting visible muscle contraction and is intended to increase sensory afferent input.
The primary outcome is ankle dorsiflexion range of motion. Secondary outcomes include inversion and eversion range of motion, spasticity measures, muscle mechanical properties, and functional outcomes including mobility and independence in daily activities. Assessments are performed at all three study visits to evaluate change over time across the intervention phases.
The study is designed to explore feasibility and preliminary clinical change patterns associated with this combined rehabilitation approach. Because the study does not include a concurrent control group, the findings are intended to provide preliminary evidence to inform future randomized controlled trials.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
No masking is used in this study. Because of the nature of the rehabilitation intervention, participants, care providers, and investigators are aware of the treatment being delivered.
入排标准
- 年龄范围
- 5 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 5 to 15 years
- •Diagnosis of spastic cerebral palsy
- •Gross Motor Function Classification System (GMFCS) level I or II
- •Ability to understand simple verbal instructions
- •Parent or legal guardian able and willing to provide informed consent
排除标准
- •Clinically relevant sensory deficits that could affect stimulation perception or outcome assessments
- •Uncontrolled epileptic seizures
- •Severe perceptual or cognitive problems preventing cooperation
- •Significant visual or hearing impairment
- •GMFCS level III or higher
- •Botulinum toxin injection or orthopedic surgery within the previous 6 months
- •Fixed ankle contracture or severe musculoskeletal deformity limiting range of motion
结局指标
主要结局
Ankle Dorsiflexion Range of Motion
时间窗: Baseline, Week 6, and Week 12
Ankle dorsiflexion range of motion will be measured to evaluate change across the study intervention phases in children with spastic cerebral palsy.
次要结局
未报告次要终点
研究者
Veysel Akduman
Research Assistant
Harran University