Vibration Effects on Gait and Balance in CP

NCT07045519 | Recruiting

• 2 other identifiers: KırıkkaleBetulYılmazBetül Şevval Yılmaz
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Keywords

Hemiparetic Cerebral Palsy; Randomized Controlled Trial; Modified Ashworth Scale; Tardieu Scale; Gross Motor Function; Pediatric Physiotherapy; Gait Analysis; Balance Assessment; Gastrocnemius Muscle; Spasticity; Local Vibration Therapy

Outcome Measures

Primary Outcomes (7)

• Modified Tardieu Scale (MTS)

  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).

  Baseline and immediately after intervention

• Gross Motor Function Classification System (GMFCS):

  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).

  Baseline

• Pediatric Berg Balance Scale (PBBS):

  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).

  Baseline

• Timed Up and Go Test (TUG):

  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.

  Baseline and immediately after intervention

• 10-Meter Walk Test (10MWT):

  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).

  Baseline and immediately after intervention

• Pediatric Reach Test

  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).

  Baseline and immediately after intervention

• Tandem Stance Test

  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).

  Baseline and immediately after intervention

Secondary Outcomes (7)

• 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

Study Arms (2)

Experimental: Local Vibration Therapy

EXPERIMENTAL

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

Device: Local Vibration Therapy

Placebo Comparator: Sham Vibration

PLACEBO COMPARATOR

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.

Device: Sham Vibration

Interventions

Local Vibration Therapy 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.

Experimental: Local Vibration Therapy

Sham Vibration 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.

Placebo Comparator: Sham Vibration

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kırıkkale University: lead

Study Sites (2)

Ankara Yıldırım Beyazıt University

Ankara, Turkey (Türkiye)

RECRUITING

Kırıkkale University

Kırıkkale, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Muscle Spasticity

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Betül Ş Yılmaz, Pt.

CONTACT

+905069627501; betulsevvalunal1@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Kırıkkale University

Study Record Dates

• First Submitted: May 16, 2025
• First Posted: July 1, 2025
• Study Start: June 29, 2025
• Primary Completion: January 29, 2026
• Study Completion: March 29, 2026
• Last Updated: August 29, 2025

Record last verified: 2025-06

Locations

TU (2)