Description

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.

Balance will be assessed using the Timed Up and Go Test (TUG), Pediatric Reach Test, and Tandem Stance Test. Spatiotemporal gait parameters will be analyzed using a wireless miniature digital gait analysis system.

Inclusion Criteria:

• Children aged 4-18 years diagnosed with hemiparetic CP,
• GMFCS Level I-II (ambulatory without support),
• Spasticity in the gastrocnemius muscle (Modified Ashworth Scale 1, 1+, or 2),
• Able to follow verbal instructions,
• No Botox treatment in the last 3 months or surgery in the last 6 months,
• Voluntary participation with informed parental consent.

Exclusion Criteria:

• Botox treatment or surgery for spasticity within the past 6 months,
• Neurological disorders other than CP, joint pain, or fracture history affecting independent standing/walking,
• Severe intellectual disability preventing compliance,
• Behavioral problems during assessment,
• Lack of consent.

Assessment Parameters:

• Balance: Pediatric Berg Balance Scale (PBBS), Timed Up and Go Test (TUG), Pediatric Reach Test, Tandem Stance, Single-leg Stance.
• Gross Motor Function: Gross Motor Function Measure (GMFM).
• Spasticity: Modified Ashworth Scale (MAS), Modified Tardieu Scale (MTS).
• Gait Analysis: Spatiotemporal parameters via digital gait analysis system.

The Modified Tardieu Scale will be used to measure the quality and angle of muscle reaction to passive stretch at three different velocities (V1, V2, V3).

The Pediatric Berg Balance Scale consists of 14 items scored from 0 to 4, evaluating functional balance in daily life activities.

The digital gait analysis system uses an accelerometer-based sensor attached to the pelvis to measure walking parameters.

Intervention Protocol:

Treatment Group:

Local vibration will be applied to the most prominent area of the spastic medial gastrocnemius muscle using the Vibrasens® (Techno Concept, France). The device delivers non-invasive mechanical vibrations. A 10-minute session of local vibration at 80 Hz with 1 mm amplitude will be administered.

Placebo Group:

The device will be placed on the same muscle area for 10 minutes without delivering vibration. Participants will only feel the contact of the device.

Statistical Analysis:

• Continuous variables will be expressed as mean ± standard deviation.
• Shapiro-Wilk test will assess normality.
• Independent t-test or Mann-Whitney U test will compare groups depending on data distribution.
• Chi-square test will be used for categorical variables.
• Within-group comparisons will use paired t-tests or Wilcoxon tests as appropriate.