The Acute Effects of Local Vibration Application to the Gastrocnemius Muscle on Gait and Balance in Individuals With Hemiparetic Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Pediatric Berg Balance Scale (PBBS):
研究概览
简要总结
This randomized controlled study aims to investigate the acute effects of local vibration applied to the spastic medial gastrocnemius muscle on balance and spatiotemporal gait parameters in children with hemiparetic cerebral palsy. Children aged 4 to 18 years with spasticity levels of 1 to 2 on the Modified Ashworth Scale and Gross Motor Function Classification System (GMFCS) levels I-II will be included. Participants will be randomly assigned to either a treatment group receiving local vibration or a placebo group. Assessments will be conducted before, immediately after, and 30 minutes after the intervention. Balance will be assessed using the Timed Up and Go Test (TUG), Pediatric Reach Test, Tandem Stance Test, and Pediatric Berg Balance Scale. Spatiotemporal gait parameters will be measured using a digital gait analysis system. The results will provide insights into the immediate effectiveness of localized vibration therapy in pediatric cerebral palsy rehabilitation.
详细描述
Children with cerebral palsy (CP) are known to have postural control deficits and motor impairments, primarily due to damage in brain areas responsible for postural regulation. These deficits often lead to balance and orientation problems, particularly affecting motor tasks such as walking. Despite various therapeutic approaches, many children with CP continue to experience difficulties in achieving independent ambulation.
Recent studies have shown that vibration therapy may enhance walking performance in children with CP. Local vibration applied to the spastic gastrocnemius muscle has been associated with improvements in muscle tone, functional gait parameters, and electromyographic patterns. However, the literature is predominantly focused on whole-body vibration and its effects on spasticity. There is a lack of research specifically examining the effects of local vibration on balance and gait parameters in individuals with spastic CP.
This randomized controlled trial aims to investigate the acute effects of local vibration applied to the spastic gastrocnemius muscle on balance and spatiotemporal gait parameters in children with hemiparetic cerebral palsy.
Participants will be recruited from a private special education and rehabilitation center. Sample size will be determined based on a power analysis following a pilot study. Individuals classified as Level I or II according to the Gross Motor Function Classification System (GMFCS) will be included. Participants will be randomly assigned to either the treatment or placebo group using a coin-flip method. Evaluations will be conducted before the intervention, immediately after, and 30 minutes post-intervention.
Demographic and clinical information such as age, gender, type of CP, use of assistive devices, history of surgery, and orthopedic deformities will be recorded. Assessments will be performed by experienced physiotherapists.
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 (Investigator)
入排标准
- 年龄范围
- 4 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of cerebral palsy, classified as GMFCS Level I or II
- •Aged between 4 and 18 years
- •Presence of spasticity in the gastrocnemius muscle (Modified Ashworth Scale score of 1, 1+, or 2)
- •Able to walk independently
- •Ability to follow verbal instructions
- •No botulinum toxin injection in the past 3 months
- •No lower limb surgery in the past 6 months
- •Voluntary participation with written and verbal informed consent obtained from parents or legal guardians
排除标准
- •Botulinum toxin injection or surgical intervention for spasticity within the past 6 months
- •Neurological disorders other than cerebral palsy
- •Musculoskeletal problems that may affect standing or walking (e.g., joint pain, lower extremity fractures within the past 6 months)
- •Severe cognitive impairment preventing understanding of basic commands
- •Behavioral problems or poor cooperation that interfere with assessments
- •Lack of written informed consent from parents or legal guardians
结局指标
主要结局
Pediatric Berg Balance Scale (PBBS):
时间窗: Baseline
The PBBS is a modified version of the original Berg Balance Scale, adapted by Franjoine et al. for use in children. It is used to evaluate functional balance during daily living activities (Franjoine et al., 2003). The PBBS consists of 14 items, each scored from 0 to 4. The Turkish version was published by Erden et al. (2011).
Modified Tardieu Scale (MTS)
时间窗: Baseline and immediately after intervention
The MTS is a clinical tool used to assess spasticity. Although not as commonly used as the Modified Ashworth Scale (MAS), it is considered a more effective method for evaluating spasticity because it measures resistance to passive movement at two different velocities (Tardieu et al., 1999). The Modified Tardieu Scale includes: Quality of muscle reaction (X): Rated on a scale from 0 (no resistance to passive movement) to 5 (joint is immobile). Angle of muscle reaction (Y): Measured with a goniometer relative to the position in which the muscle is at its shortest length. Stretching velocities: The assessment is performed at three different velocities: V1 (slow), V2 (gravity), and V3 (fast) (Tardieu et al., 1999; Patrick \& Ada, 2006).
Gross Motor Function Classification System (GMFCS):
时间窗: Baseline
The GMFCS evaluates sitting, transfers, and mobility. It classifies children based on their age and motor skills. The system includes five levels that clearly define functional differences (Palisano et al., 2008). The Turkish version of the GMFCS was developed by Kerem Günel and colleagues. Levels: Level I: Walks without limitations. Level II: Walks with limitations. Level III: Walks using a hand-held mobility device. Level IV: Self-mobility is limited; may use powered mobility. Level V: Transported in a manual wheelchair (Günel et al., 2010).
Timed Up and Go Test (TUG):
时间窗: Baseline and immediately after intervention
The TUG test assesses postural control, walking speed, functional mobility, and balance in children with cerebral palsy (Rose et al., 2011). During the test, the child rises from a chair, walks 10 meters, turns around, and returns to sit down. The test is timed with a stopwatch.
10-Meter Walk Test (10MWT):
时间窗: Baseline and immediately after intervention
This test measures the time it takes for an individual to walk 10 meters at a self-selected comfortable pace. It is commonly used to guide rehabilitation planning in individuals with cerebral palsy (Li et al., 2012).
Pediatric Reach Test
时间窗: Baseline and immediately after intervention
This test evaluates the dynamic component of balance. Children are asked to reach forward and sideways without lifting their heels, and the distance is measured in centimeters (Fay et al., 2007).
Tandem Stance Test
时间窗: Baseline and immediately after intervention
The child is instructed to stand with one foot placed heel-to-toe in front of the other. The test is conducted in two phases: with eyes open and with eyes closed (Franjoine et al., 2003).
Modified Tardieu Scale (MTS)
时间窗: Baseline and immediately after intervention
The MTS is a clinical tool used to assess spasticity. Although not as commonly used as the Modified Ashworth Scale (MAS), it is considered a more effective method for evaluating spasticity because it measures resistance to passive movement at two different velocities (Tardieu et al., 1999). The Modified Tardieu Scale includes: Quality of muscle reaction (X): Rated on a scale from 0 (no resistance to passive movement) to 5 (joint is immobile). Angle of muscle reaction (Y): Measured with a goniometer relative to the position in which the muscle is at its shortest length. Stretching velocities: The assessment is performed at three different velocities: V1 (slow), V2 (gravity), and V3 (fast) (Tardieu et al., 1999; Patrick \& Ada, 2006).
Pediatric Berg Balance Scale (PBBS):
时间窗: Baseline
The PBBS is a modified version of the original Berg Balance Scale, adapted by Franjoine et al. for use in children. It is used to evaluate functional balance during daily living activities (Franjoine et al., 2003). The PBBS consists of 14 items, each scored from 0 to 4. The Turkish version was published by Erden et al. (2011).
Pediatric Reach Test
时间窗: Baseline and immediately after intervention
This test evaluates the dynamic component of balance. Children are asked to reach forward and sideways without lifting their heels, and the distance is measured in centimeters (Fay et al., 2007).
Tandem Stance Test
时间窗: Baseline and immediately after intervention
The child is instructed to stand with one foot placed heel-to-toe in front of the other. The test is conducted in two phases: with eyes open and with eyes closed (Franjoine et al., 2003).
次要结局
- Cadence (steps/min)(Baseline and immediately after intervention)
- Double Support Time (s)(Baseline and immediately after intervention)
- Stance Time (s)(Baseline and immediately after intervention)
- Swing Time (s)(Baseline and immediately after intervention)
- Walking Speed (m/s)(Baseline and immediately after intervention)
- Step Length (cm)(Baseline and immediately after intervention)
- Stride Length (cm)(Baseline and immediately after intervention)
- Walking Speed (m/s)(Baseline and immediately after intervention)
- Step Length (cm)(Baseline and immediately after intervention)
- Stride Length (cm)(Baseline and immediately after intervention)
- Cadence (steps/min)(Baseline and immediately after intervention)
- Double Support Time (s)(Baseline and immediately after intervention)
- Stance Time (s)(Baseline and immediately after intervention)
- Swing Time (s)(Baseline and immediately after intervention)
研究者
Saniye Aydoğan Arslan
Kırıkkale University
Kırıkkale University