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NCT Number: NCT07248267

Effects of Vojta Therapy on Functional Mobility and Gait Parameters in Children With Down Syndrome

This randomized clinical trial investigates the effects of Vojta therapy on functional mobility and gait parameters in children with down syndrome. The study involves 28 male and female children aged 2-10 years old, who will be randomly assigned to one of the two groups i.e. control and experimental group. Key performance outcomes -GMFM 88 and gait outcome assessment -will be assessed both before and after the intervention. The research aims to evaluate the effects of vojta therapy on functional mobility and gait parameters in children with down syndrome. This RCT study will examine the potential key parameters of gait I.e. its spacial parameters that are step length, stride length, stride width, In and out toe and BOS and functional mobility Data will be analyzed through SPSS version 27.00.

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Key information

Age range

2 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hashim

Lahore, Punjab Province, 54000, Pakistan

Location status: Recruiting

Location contact

Muhammad Asif Jvaed, MS-PT

CONTACT

[email protected]

923224209422

About this study

This randomized clinical trial provides a detailed effects of Vojta therapy on functional mobility and gait parameters in children with down syndrome. The study is grounded to evaluate the effects of vojta therapy on functional mobility and gait parameters in children with down syndrome. This RCT study will examine the potential key parameters of gait I.e its spacial parameters that are step length , stride length , stride width ,In and out toe and BOS and functional mobility and this study will add potential information in field of pediatrics by examining whether vojta therapy an effective therapeutic intervention over conventional therapeutic plan of care .The study will give the evidence based therapeutic intervention for improvement of DS patient's quality of life and overall mobility .study will be helpful for broader application of reflexive therapies if study will yield supporting results for treating children of down syndrome and their improving their alarming functional mobility and gait commodities.

The study will recruit 28 children with down syndrome between the ages of 2 and 10, who will be randomly assigned to either to control and experimental intervention group for a eight-week period. Performance will be measured using standardized tools that are GMFM 88 and gait outcomes parameters. These assessments will be conducted at baseline before the intervention begins and again immediately following the eight-week intervention given period. The collected data will be analyzed to evaluate the in-between differences of effects of intervention on both groups , with statistical adjustments for baseline values to ensure a robust comparison. The findings are expected to give the evidence based therapeutic intervention for improvement of DS patient's quality of life and overall mobility .study will be helpful for broader application of reflexive therapies if study will yield supporting results for treating children of down syndrome and their improving their alarming functional mobility and gait commodities. Data will be analyzed through SPSS version 27.00.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age: 2-10 years old
  • Confirmed diagnosis of Down syndrome by pediatric neurologist.
  • Written informed consent obtained from parents or guardians.
  • Independent standing and walking abilities assessed by GMFM dimension D and E.
  • Functional hearing and vision, and understanding of instructions which were necessary for the measurement procedures
  • No other physical therapy or interventions within the past three months

Exclusion criteria

  • Presence of other significant medical conditions (e.g., severe cardiac issues).
  • History of orthopedic surgery or significant musculoskeletal issues affecting mobility.
  • Any additional neurological disorders that could confound results.
  • Patient with Serious cognitive & behavior issues that would interfere with group participation.
  • Participation in other clinical trials during the study period

Treatment and study plan

Vojta Therapy

Other

The intervention group received Vojta therapy. Vojta therapy was implemented by stimulating the chest zone, which is located between the 7th and 8th rib, use of additional zones was allowed to support the activation. The starting positions for Vojta therapy were supine or side-lying position with the head turned 30°toward the side being stimulated or side-lying. Patients were treated for 30 min.Vojta defined two main movements:

Reflex crawling: Stimulating key points on the shoulders and pelvis in this position can help engage the extensor and flexor muscles of the spine, encouraging spinal alignment, limb movement, and balance development

repetitive sensorimotor exercises

Other

The intervention should focus on strength training i.e:Core Stability and Trunk Control Exercises:

Target Muscles: Core stability exercises focus on strengthening the muscles of the trunk, essential for postural control and balance.

Exercises: Activities like sit-to-stand exercises, balance board training, and core strengthening using resistance bands are commonly used.

Balance and Coordination Training :Dynamic Balance Exercises: Activities such as standing on one leg, heel-to-toe walking, and using a balance ball help to strengthen lower limb muscles and improve overall coordination.(30) Proprioceptive Activities: Including balance boards and foam pads for standing exercises can enhance proprioceptive feedback, essential for motor planning and gait adjustments

Primary outcomes

  1. 1. GMFM-88 scale

    Time frame: 8 weeks

    • GMFM-88 scale was primary designed to evaluated change in gross motor function of children with CP. At present, 88 items may be used to assess children with DS. Motor functions are grouped in 5 dimensions in GMFM-88: 1) lying and rolling (17 items), 2) sitting (20 items), 3) crawling and kneeling (14 items), 4) standing (13), 5) walking, running and jumping (24 items) [12, 13]. Referring to the guidelines of GMFM-88 assessment for children with DS, the environment should be as familiar to the children as possible, and arranged in such a way to encourage the performance of activities. children performed many tasks spontaneously.. Each task was measured by observation and scored on a 4-point ordinal scale. Value 0 indicated that a child did not initiate the task, 1 point - performed less than 10% of the task, 2 points - a child partially completed a task (10% to< 100%), 3 points - the child completed the task (100%)

Study contacts

Contact information is provided by the study sponsor or research team.

IMRAN AMJAD, PhD

CONTACT

[email protected]

9233224390125

Muhammad Asif Javed, MS-PT

CONTACT

[email protected]

923224209422

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effects of Vojta Therapy on Functional Mobility and Gait Parameter in Children With Down Syndrome

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 25, 2025
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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