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

NCT ID: NCT07248267

Last Updated: 2025-11-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-22
• Study Completion Date: 2026-01-30

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.

Detailed Description

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.

Conditions

Down Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Active Comparator:Vojta Therapy

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.

Group Type: EXPERIMENTAL

Vojta Therapy

Intervention Type: 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

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

Group Type: PLACEBO_COMPARATOR

repetitive sensorimotor exercises

Intervention Type: 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

Interventions

Vojta Therapy

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

Intervention Type: OTHER

repetitive sensorimotor exercises

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Riphah International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ayesha Tanveer, MS-PT

Role: PRINCIPAL_INVESTIGATOR

Riphah International University

Locations

Hashim

Lahore, Punjab Province, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

IMRAN AMJAD, PhD

Role: CONTACT

imran.amjad@riphah.edu.pk

9233224390125

Muhammad Asif Javed, MS-PT

Role: CONTACT

a.javed@riphah.edu.pk

923224209422

Facility Contacts

Muhammad Asif Jvaed, MS-PT

Role: primary

a.javed@riphah.edu.pk

923224209422

References

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.

Reference Type: BACKGROUND

PMID: 40108222 (View on PubMed)

Other Identifiers

REC/RCR&AHS/AYESHA

Identifier Type: -

Identifier Source: org_study_id