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

NCT07248267 | Recruiting DMC

• 1 other identifier: REC/RCR&AHS/AYESHA
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Down Syndrome

Keywords

Downs syndrome, Vojta therapy,Rehabilitation

Outcome Measures

Primary Outcomes (1)

• 1. GMFM-88 scale

  1\. 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%)

  8 weeks

Study Arms (2)

Active Comparator:Vojta Therapy

EXPERIMENTAL

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 with Vojta therapy and afterwards were mobilized with gait training, if feasible. It is recommended that therapy be carried out 30-40 min per day, thrice week. Same types of movements were detected to emerge by applying stimulus to certain points in newborns and s down children 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.

Other: Vojta Therapy

repetitive sensorimotor exercises

PLACEBO COMPARATOR

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

Other: repetitive sensorimotor exercises

Interventions

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

Active Comparator:Vojta Therapy

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

repetitive sensorimotor exercises

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Hashim

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Related Publications (1)

• Panchal R, Rizvi MR, Sharma A, Ahmad F, Hasan S, Shaik AR, Seyam MK, Uddin S, Ahamed WM, Iqbal A, Alghadir AH. Comparing the effectiveness of the FIFA 11+ warm-up and conventional warm-up in enhancing cyclist performance and mitigating injury risk. Sci Rep. 2025 Mar 19;15(1):9430. doi: 10.1038/s41598-025-91005-z.

  PMID: 40108222 BACKGROUND

MeSH Terms

Conditions

Down Syndrome

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn

Study Officials

• Ayesha Tanveer, MS-PT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

IMRAN AMJAD, PhD

CONTACT

9233224390125; imran.amjad@riphah.edu.pk

Muhammad Asif Javed, MS-PT

CONTACT

923224209422; a.javed@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will get separate treatment protocols and possible efforts will be put to mask the both group about the treatment. The participant will be blinded throughout the session but the therapist will not be blinded
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomized clinical trial (RCT) designed to compare the effectiveness of vojta therapy on functional mobility and gait parameters on down syndrome children. The study will involve 28 down syndrome children between the ages of 2 and 10. These participants will be randomly divided into two groups. One group will follow Vojta Therapy- Reflexive locomotion that is induced through two positions and 10 stimulus zones. Frequency: 3 times per week for Duration: 30-45 minutes per session. The other group will use Passive range of motion (PROM) and maintain the positioning of child. The control group received conventional physiotherapy which consisted of repetitive sensorimotor exercises

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 25, 2025
• Study Start: October 22, 2025
• Primary Completion: January 30, 2026
• Study Completion: January 30, 2026
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)