Vibration Effects on Gait and Balance in CP
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Local Vibration Therapy, Sham Vibration.
- Who it may be relevant to
- Registry conditions: Cerebral Palsy Hemiparetic Cerebral Palsy Spasticity Gait Disorders, Neurologic Postural Balance Impairment. Basic parameters: 4 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Acute Effects of Local Vibration Application to the Gastrocnemius Muscle on Gait and Balance in Individuals With Hemiparetic Cerebral Palsy
Overview
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.
Detailed 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.
Interventions
- Device Local Vibration Therapy
Local vibration (LV) will be applied using the Vibrasens© device (Techno Concept, Mane, France). Vibrasens© is a non-invasive therapeutic mechanical vibrator used for transcutaneous vibratory stimulation in sensorimotor rehabilitation. The system includes one pilot unit, one manual vibrator (VB200), four flat skin contactors for tendon applications, four round skin contactors for surface applications, a power supply, a user manual, and a protocol guide. - Device Sham Vibration
Participants will receive sham stimulation by placing the Vibrasens© device on the same area as the treatment group for 10 minutes, without activating the vibration function. They will be informed that they will only feel the contact of the device.
Primary outcome measures
- Modified Tardieu Scale (MTS) [Time frame: Baseline and immediately after intervention]
- Gross Motor Function Classification System (GMFCS): [Time frame: Baseline]
- Pediatric Berg Balance Scale (PBBS): [Time frame: Baseline]
- Timed Up and Go Test (TUG): [Time frame: Baseline and immediately after intervention]
- 10-Meter Walk Test (10MWT): [Time frame: Baseline and immediately after intervention]
- Pediatric Reach Test [Time frame: Baseline and immediately after intervention]
- Tandem Stance Test [Time frame: Baseline and immediately after intervention]
Secondary outcome measures (7)
- Walking Speed (m/s) [Time frame: Baseline and immediately after intervention]
- Step Length (cm) [Time frame: Baseline and immediately after intervention]
- Stride Length (cm) [Time frame: Baseline and immediately after intervention]
- Cadence (steps/min) [Time frame: Baseline and immediately after intervention]
- Double Support Time (s) [Time frame: Baseline and immediately after intervention]
- Stance Time (s) [Time frame: Baseline and immediately after intervention]
- Swing Time (s) [Time frame: Baseline and immediately after intervention]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Turkey (Türkiye) · 2 centers
- Ankara Yıldırım Beyazıt University — Ankara
- Kırıkkale University — Kirikkale
Identifiers
NCT: NCT07045519 · KırıkkaleBetulYılmaz · Betül Şevval Yılmaz