- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07291128
Effects of VOJTA Technique on Ataxic Cerebral Palsy. (rct cp)
Effects of VOJTA Technique on Muscle Tone, Gross Motor Function and Balance on Ataxic Cerebral Palsy.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Fareeha Ijaz fareeha, Masters
- Phone Number: +923201014615
- Email: Fareehaijaz2018@gmail.com
Study Contact Backup
- Name: Salwa Atta Salwa, supervisor
- Email: salwa.atta@ubas.edu.pk
Study Locations
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan, 33351
- Recruiting
- Department of Physical Therapy
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group 1/ VOJTA
Participants in this arm will receive VOJTA reflex locomotion therapy, which involves activating innate locomotor patterns through manual stimulation of specific pressure zones while the child is positioned in standardized postures.
This arm examines the effectiveness of VOJTA therapy in improving muscle tone, balance, and gross motor function in children with ataxic cerebral palsy
|
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 stimulation.
The frequency will be 5 sessions per week for 8 weeks with duration of 30 minutes.
|
|
Active Comparator: Group 2 / Conventional Physical Therapy
Participants in this arm will receive routine conventional physiotherapy commonly used for cerebral palsy rehabilitation.
This includes Neurodevelopmental Therapy (NDT/Bobath-based methods), balance training, core strengthening, stretching, and functional task-oriented exercises.
This arm serves as the comparison group.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Modified Ashworth Scale (MAS)
Time Frame: Baseline, 4 weeks, 8 weeks
|
Muscle tone will be evaluated using the Modified Ashworth Scale, which measures resistance during passive movement to assess tone abnormalities.
Scores range from 0 to 4, with higher scores indicating increased resistance or greater tone abnormality.
Improvement is defined as a reduction in MAS scores or normalization of tone patterns following the intervention period.
|
Baseline, 4 weeks, 8 weeks
|
|
Gross Motor Function Measure-88 (GMFM-88)
Time Frame: Baseline, 4 weeks, 8 weeks
|
Gross motor function will be assessed using the GMFM-88, a validated observational measure designed to evaluate changes in motor skills across five domains (lying/rolling; sitting; crawling/kneeling; standing; walking/running/jumping).
Total and domain-specific scores will be analyzed.
Improvement is defined as an increase in GMFM-88 scores after the intervention.
|
Baseline, 4 weeks, 8 weeks
|
|
Pediatric Balance Scale (PBS)
Time Frame: Baseline, 4 weeks, 8 weeks
|
Balance performance will be measured using the Pediatric Balance Scale, which includes 14 tasks assessing static and dynamic balance in functional positions.
Scores range from 0 to 56, with higher scores representing better balance control.
Improvement is defined as an increase in PBS scores following treatment.
|
Baseline, 4 weeks, 8 weeks
|
Collaborators and Investigators
Publications and helpful links
General 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UBAS/ERB/FoRS/25/043 Fareeha
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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