- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07248267
Effects of Vojta Therapy on Functional Mobility and Gait Parameters in Children With Down Syndrome
Effects of Vojta Therapy on Functional Mobility and Gait Parameter in Children With Down Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: IMRAN AMJAD, PhD
- Phone Number: 9233224390125
- Email: imran.amjad@riphah.edu.pk
Study Contact Backup
- Name: Muhammad Asif Javed, MS-PT
- Phone Number: 923224209422
- Email: a.javed@riphah.edu.pk
Study Locations
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-
Punjab Province
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Lahore, Punjab Province, Pakistan, 54000
- Recruiting
- Hashim
-
Contact:
- Muhammad Asif Jvaed, MS-PT
- Phone Number: 923224209422
- Email: a.javed@riphah.edu.pk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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. |
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 |
|
Placebo Comparator: 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 |
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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%)
|
8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ayesha Tanveer, MS-PT, Riphah International University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR&AHS/AYESHA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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