- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04536506
Bobath and Vojta Therapy for DS
Comparison of the Effectiveness of Bobath Therapy and Vojta Technique in Babies With Down Syndrome Aged 0-24 Months: A Randomized Controlled Study
Different physiotherapy approaches and education programs are applied to minimize motor and mental impairment in children with Down syndrome (DS). The present study was conducted with the aim of comparing the effectiveness of two different physiotherapy approaches in babies with Down syndrome in the early period.
A total of 23 babies with DS aged between 0-24 months were included in the study. Infants were randomly divided to two groups: Bobath therapy (BT) group included 12 infants (6 girls and 6 boys) and Vojta technique (VT) group included 11 infants (4 girls and 7 boys). The infants were applied a total of 12 sessions of physiotherapy (twice weekly during 6 weeks). Alberta Infant Motor Scale (AIMS) was used for comparison of motor development level before and after the therapy. Emotional status of the mothers was evaluated with Beck Depression Scale (BDS) and quality of life was evaluated with Nottigham Health Profile (NHP).
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Denizli, Turkey, 20070
- Pamukkale University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- being between 0 and 2 years
- being diagnosed with DS
Exclusion Criteria:
- having an additional neuro-motor disease
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment group
Bobath group received 45 min of sessions three times weekly for 12 weeks.
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Bobath group received 45 min of sessions three times weekly for 12 weeks.
An individual program was scheduled for each case following pre-assessment.
It was targeted to enable normal posture, facilitation of corrective balance and protective responses and development of normal movement patterns
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Active Comparator: Control group
Vojta group received the following three times weekly for 12 weeks.
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Vojta group received the following three times weekly for 12 weeks: 1. Reflex crawling, 2. First stage of reflex turning, 3. Second stage of reflex turning.
Stimuli (pressure and stretch) for 30-60 sec were given by using the main stimulus points and auxiliary stimulus points together.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Alberta Infant Motor Scale
Time Frame: 12 weeks
|
Alberta Infant Motor Scale is a tool which evaluates the infants from baby to independently walking children and measures delay in motor performance, enables families and clinicians to obtain data about motor performance of the infant, compares motor performance before and after therapy.
The child is observed when performing spontaneous behaviors with a certain postural control.
The scale measures weight transfer, posture and anti-gravity movements at supine, prone, sitting and standing positions with 58 items.
The child receives 1 point for the movements he/she can perform and 0 point for the ones that he/she cannot perform.
It is a reliable test with norm reference and suitable for clinical use due to taking short time.
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12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Beck Depression Scale
Time Frame: 12 weeks
|
Beck Depression Scale is a scale used for evaluating emotional status of the mothers and it was arranged so as to include the symptoms of depression.
Items of the scale were prepared based on clinical observations and data, not based on any hypothetical opinion.
The Likert type scale is composed of 21 symptom categories.
Each symptom category is scored between 0 and 3 with the highest possible score of 63.
Higher scores indicates more severe depression.
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12 weeks
|
Nottingham Health Profile
Time Frame: 12 weeks
|
Nottingham Health Profile was used for assessment of quality of life of the mothers.
This is a scale which is commonly used in clinical practice and includes 38 items that evaluate quality of life in 6 sections (pain, energy level, social isolation, emotional reaction, physical activity).
Ratio of the "yes" answers is evaluated and each section is scored between 0 and 100 where 0 is the best and 100 is the worst score
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12 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- 60116787-020/66911
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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