Vibration Effects on Gait and Balance in CP

NCT ID: NCT07045519

Last Updated: 2025-08-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-29
• Study Completion Date: 2026-03-29

Brief Summary

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.

Conditions

Cerebral Palsy Hemiparetic Cerebral Palsy Spasticity Gait Disorders, Neurologic Postural Balance Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental: Local Vibration Therapy

Participants in the treatment group will receive local vibration applied for 10 minutes to the most prominent area of the spastic medial gastrocnemius muscle.

Group Type: EXPERIMENTAL

Local Vibration Therapy

Intervention Type: DEVICE

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.

Placebo Comparator: Sham Vibration

Participants in the placebo group will be placed in the prone position and the vibration device will be placed on the same area as in the treatment group for 10 minutes without delivering any vibration.

Group Type: PLACEBO_COMPARATOR

Sham Vibration

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kırıkkale University

OTHER

Sponsor Role: lead

Responsible Party

Saniye Aydoğan Arslan

Kırıkkale University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ankara Yıldırım Beyazıt University

Ankara, , Turkey (Türkiye)

Site Status: RECRUITING

Kırıkkale University

Kırıkkale, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Betül Ş Yılmaz, Pt.

Role: CONTACT

betulsevvalunal1@gmail.com

+905069627501

Facility Contacts

Betül Ş Yılmaz, MSc. Pt.

Role: primary

betulsevvalunal1@gmail.com

+905069627501

Other Identifiers

Betül Şevval Yılmaz

Identifier Type: OTHER

Identifier Source: secondary_id

KırıkkaleBetulYılmaz

Identifier Type: -

Identifier Source: org_study_id