NCT07291128

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 5, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

December 8, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 18, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

December 30, 2025

Status Verified

December 1, 2025

Enrollment Period

5 months

First QC Date

December 5, 2025

Last Update Submit

December 23, 2025

Conditions

Keywords

vojtamuscle toneataxic cerebral palsygross motor functionbalance

Outcome Measures

Primary Outcomes (3)

  • Modified Ashworth Scale (MAS)

    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)

    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)

    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

Study Arms (2)

Group 1/ VOJTA

EXPERIMENTAL

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

Behavioral: VOJTA

Group 2 / Conventional Physical Therapy

ACTIVE COMPARATOR

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.

Behavioral: Conventional Physical Therapy

Interventions

VOJTABEHAVIORAL

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.

Group 1/ VOJTA

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.

Group 2 / Conventional Physical Therapy

Eligibility Criteria

Age2 Years - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Physical Therapy

Lahore, Punjab Province, 33351, Pakistan

RECRUITING

Related Publications (2)

  • 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.

MeSH Terms

Conditions

Cerebral Palsy, Ataxic, Autosomal Recessive

Central Study Contacts

Fareeha Ijaz fareeha, Masters

CONTACT

Salwa Atta Salwa, supervisor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: After recruitment of participants into study they will be allocated to their respective groups utilizing the online randomizer tool.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2025

First Posted

December 18, 2025

Study Start

December 8, 2025

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

December 30, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations