Down SyndromeNCT07248267
Effects of Vojta Therapy on Functional Mobility and Gait Parameters in Children With Down Syndrome
A study testing Vojta Therapy and repetitive sensorimotor exercises in people with Down Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Down Syndrome
- What is being tested?
- Vojta Therapy and repetitive sensorimotor exercises
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 sitePakistan
- Study dates
- 22 Oct 2025to 30 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Hashim
Lahore, Punjab Province, 54000
Muhammad Asif Jvaed, MS-PT, 923224209422, a.javed@riphah.edu.pk
About this study
Official title: Effects of Vojta Therapy on Functional Mobility and Gait Parameter 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.
Read the 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
- Being tested
- Vojta Therapy, repetitive sensorimotor exercises
- Keywords
- Downs syndrome, Vojta therapy,Rehabilitation
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vojta TherapyOther
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 exercisesOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: repetitive sensorimotor exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. GMFM-88 scale
- 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%)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start22 Oct 2025
- Primary completion30 Jan 2026 (estimated)
- Study completion30 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Down SyndromeStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ayesha Tanveer, MS-PT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07248267
- Sponsor's protocol ID
- REC/RCR&AHS/AYESHA
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 25 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40108222
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Vojta Therapy on Functional Mobility and Gait Parameter in Children With Down Syndrome
- ClinicalTrials.gov ID
- NCT07248267
- Acronym / sponsor ID
- REC/RCR&AHS/AYESHA
- Conditions
- Down Syndrome
- Keywords
- Downs syndrome, Vojta therapy,Rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 22 Oct 2025 (actual)
- Primary completion
- 30 Jan 2026 (estimated)
- Study completion
- 30 Jan 2026 (estimated)
- First posted
- 25 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Active Comparator:Vojta Therapy | Experimental | Other: Vojta TherapyThe 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. |
| repetitive sensorimotor exercises | Placebo comparator | Other: repetitive sensorimotor exercisesThe 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 |
Who may qualify
- Ages
- 2 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vojta TherapyThe 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 | Other | Active Comparator:Vojta Therapy |
| repetitive sensorimotor exercisesThe 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 |
Primary outcome
1. GMFM-88 scale
Time frame: 8 weeks
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%)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2025.
- Background: PubMed 40108222Panchal 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ayesha Tanveer, MS-PT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vojta Therapy and repetitive sensorimotor exercises in people with Down Syndrome, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact IMRAN AMJAD, PhD (9233224390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. GMFM-88 scale (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07248267, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2025.