Vibration Effects on Gait and Balance in CP
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-18
SponsorKırıkkale University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Local Vibration Therapy
DeviceLocal 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.
Sham Vibration
DeviceParticipants 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Experimental: Local Vibration TherapyExperimental treatment 1 intervention
Group B: Placebo Comparator: Sham VibrationPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
Baseline and immediately after intervention2
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).
Time frame
Baseline3
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).
Time frame
Baseline4
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.
Time frame
Baseline and immediately after interventionSecondary outcomes
1
Walking Speed (m/s)
Walking speed will be measured using a digital gait analysis system equipped with a pelvic accelerometer to assess functional mobility.
Time frame
Baseline and immediately after intervention2
Step Length (cm)
Step length, defined as the distance between successive footfalls of alternate feet, will be measured using the digital gait analysis system.
Time frame
Baseline and immediately after intervention3
Stride Length (cm)
Stride length, the distance between successive footfalls of the same foot, will be assessed using a pelvic accelerometer during gait analysis.
Time frame
Baseline and immediately after intervention4
Cadence (steps/min)
Cadence will be measured as the number of steps taken per minute during a walking trial using a digital gait analysis system.
Time frame
Baseline and immediately after interventionSponsors and contacts
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Source ClinicalTrials.gov