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Recruiting NCT07291128

Effects of VOJTA Technique on Ataxic Cerebral Palsy.

No phase Interventional Ataxic Cerebral Palsy

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: VOJTA, Conventional Physical Therapy.
Who it may be relevant to
Registry conditions: Ataxic Cerebral Palsy. Basic parameters: 2 years — 6 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
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effects of VOJTA Technique on Muscle Tone, Gross Motor Function and Balance on Ataxic Cerebral Palsy.

Overview

Ataxic cerebral palsy (CP) is the least common subtype of CP and it is primarily caused by cerebellar damage that results in hypotonia, impaired balance, poor coordination, tremors, wide-based gait, and significant difficulties in trunk stability and uncontrolled movements. These impairments greatly affect functional mobility and independence in life. This randomized controlled trial aims to evaluate the effects of VOJTA therapy on muscle tone, gross motor function, and postural control in children with ataxic CP aged 2-6 years. VOJTA therapy is based on reflex locomotion, which activates innate central motor programs by stimulating specific pressure zones in defined positions, potentially improving postural alignment and coordinated muscle activation. A total of 40 children will be randomly assigned to either the VOJTA therapy group or a conventional physiotherapy group. Both groups will receive total of 5 sessions per week for 8 weeks and the Outcomes will be measured at baseline, 4 weeks, and 8 weeks using the Modified Ashworth Scale (MAS) for muscle tone, Gross Motor Function Measure (GMFM-88) for gross motor function and Pediatric balance scale for for balance. This study hypothesizes that VOJTA therapy will produce greater improvements in muscle tone, gross motor function and balance as compared to conventional physical therapy techniques. Findings may support evidence-based rehabilitation strategies for ataxic CP and contribute to improved functional independence and quality of life in this understudied population.

Detailed description

Cerebral palsy (CP) is a lifetime neurological condition caused by an early injury to the brain that cannot change over time, and although the brain injury itself is non-progressive, the motor problems can be different as they grow CP really affects the whole body movement, and the things that are performed by the body's muscles like, posture, coordination, muscle tone, and balance, In other cases, however, sensory processing challenges are present along with these and the child may experience delayed motor development. Among the different types of CP, ataxic cerebral palsy is the one that occurs least often, with an incidence of only around 5-10% of total CP cases. Although it is a type of cerebral palsy that is complex and therefore, more debilitating. The defining feature of ataxic CP which is mainly due to the cerebellar part of the brain being affected and motor commands of the body being uncoordinated and imprecise. Children affected by this type of CP usually have hypotonia, tremors when trying to perform a task, dysmetria, are unsteady or walk with feet far apart, have poor control of the upper body and reach motor skills later than the typical child, therefore every movement that they try to make, including the most basic ones like sitting, reaching, standing or walking, are very hard. Especially, the very important motor and communication functions of the hands, arms, and legs are affected. But although all of these problems point to a very serious form of CP, ataxic CP has so far gotten far less research attention than spastic CP and consequently, less clinical evidence-based guidance that is tailored specifically to this subtype. Most of the time, children that suffer from ataxic CP are subjected to traditional physiotherapy methods such as Neurodevelopmental Therapy, Bobath techniques, balance training, sensory integration, or strengthening exercises; however, these methods are only moderately successful as they do not directly address the specific coordination and postural control difficulties that are related to cerebellar dysfunction, thus, they do not offer any substantial change in the quality of life of the affected children. Since then the gap has become wider and that is why there is more and more interest in the neurophysiological methods that stimulate and activate the central motor pathways that are responsible for posture and movement. VOJTA therapy, which is also known as reflex locomotion therapy, provides a different method by the activation of movements that are automatic and innate through the specific stimulation of pressure that is applied while the child is in the defined postures. The treatment is thought to activate both spinal and supraspinal pathways thus increasing the muscle activation in the trunk, improving postural control, and causing the brain to generate new pathways. Studies on children suffering from cerebral palsy with spastic condition have reported better results in the areas of gross motor function, trunk stability, and early motor development. Neuroimaging has shown the activation of sensorimotor cortical areas during the stimulation of VOJTA. However, there is not enough research on the VOJTA therapy application for children with ataxic CP although they experience severe coordination and balance problems. This research intends to support filling this important gap by analyzing the VOJTA therapy effect on muscle tonicity, gross motor function, and balance in children aged 2-6 years with ataxic CP. Out of forty participants, some will be placed in the VOJTA therapy group while others will be put in the conventional physiotherapy group and the treatment will be done five times per week for eight weeks. The evaluation of the outcomes will be done at the beginning, after four weeks, and after eight weeks through the Modified Ashworth Scale for muscle tone, the Gross Motor Function Measure for motor performance, and the Pediatric Balance Scale for balance. The hypothesis of the study is that VOJTA therapy will bring about a more significant reduction of the problem in muscle tone, balance, and gross motor functions than conventional physiotherapy. This study, by concentrating on one of the least studied types of CP, has the capacity to help reshape clinical practice, enhance rehabilitation techniques better, and lead to less standard and more evidence-based care for the child with CP.

Interventions

  • Behavioral VOJTA
    VOJTA therapy will be administered by a physiotherapist. The intervention involves mechanical stimulation of defined reflex zones located on the trunk and limbs while the child is in prone, supine, or side-lying postures. Stimulation elicits automatic reflex creeping or reflex rolling patterns that enhance trunk activation, postural control, coordination, and normalization of muscle tone. Treatment follows the standardized VOJTA protocol, applying precise direction, pressure, and duration of sti
  • Behavioral Conventional Physical Therapy
    Conventional physiotherapy includes evidence-based approaches commonly applied for cerebral palsy rehabilitation. This may include NDT/Bobath principles, balance and postural stability exercises, core strengthening, stretching, functional mobility training, and sensory-motor facilitation. No VOJTA stimulation will be used. All participants follow a standardized treatment protocol to ensure consistency. The frequency will be 5 sessions per week for 8 weeks with duration of 30 minutes.

Primary outcome measures

  • Modified Ashworth Scale (MAS) [Time frame: Baseline, 4 weeks, 8 weeks]
  • Gross Motor Function Measure-88 (GMFM-88) [Time frame: Baseline, 4 weeks, 8 weeks]
  • Pediatric Balance Scale (PBS) [Time frame: Baseline, 4 weeks, 8 weeks]

Eligibility criteria

Inclusion criteria

Both male and female participants would be included

Children diagnosed with ataxic cerebral palsy.

Age range of participants will be 2 to 6 years old.

Participants included will be at level 2 on gross motor function classification scale.

Participants included will have ATNR reflex.

Stable medical condition for the past three months with no hospitalizations.

Exclusion criteria

Presence of severe comorbidities i.e. neurological or orthopedic conditions.

Patients having significant cognitive deficits

Down syndrome, hydrocephalus, epilepsy, autism and medically ill children

Children with visual or auditory deficits affecting postural control and balance assessment.

Ongoing pharmacological treatment (e.g., muscle relaxants or antiepileptic) likely to influence muscle tone or motor function during the study period

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
Double blind
Primary purpose
Treatment

Study locations

Pakistan · 1 center
  • Department of Physical Therapy — Lahore

Publications

  • Ha SY, Sung YH. Effects of Vojta approach on diaphragm movement in children with spastic cerebral palsy. J Exerc Rehabil. 2018 Dec 27;14(6):1005-1009. doi: 10.12965/jer.1836498.249. eCollection 2018 Dec. PMID 30656162
  • Sanchez-Gonzalez JL, Sanz-Esteban I, Menendez-Pardinas M, Navarro-Lopez V, Sanz-Mengibar JM. Critical review of the evidence for Vojta Therapy: a systematic review and meta-analysis. Front Neurol. 2024 Apr 22;15:1391448. doi: 10.3389/fneur.2024.1391448. eCollection 2024. PMID 38711552

Identifiers

NCT: NCT07291128 · UBAS/ERB/FoRS/25/043 Fareeha

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗