Comparison of the Effectiveness of Bobath Therapy and Vojta Technique in Babies With Down Syndrome Aged 0-24 Months: A Randomized Controlled Study
| Registry | NCT04536506 |
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| Status | Completed |
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| Phase | Not applicable |
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| Study type | Interventional; randomized, parallel, masking: none, treatment |
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| Enrollment | 23 (Actual) |
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| Sponsor | Pamukkale University (Other) |
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| Conditions | Down Syndrome, Motor Performance, Bobath Therapy, Vojta Technique |
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| Interventions | Bobath Therapy, Vojta technique (Other) |
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| Dates | start 2019-09-26, primary completion 2019-12-26, completion 2020-01-26, first posted 2020-09-02, last updated 2020-09-02 |
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| Locations | 1 site in Turkey (Türkiye) |
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Related Papers Related Patents Related Grants Related Experts
All trials for Down Syndrome All trials for Motor Performance All trials of Bobath Therapy All trials of Vojta technique
-Summary
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).
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+Arms and interventions
| Arm | Type | Interventions | Description |
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| Treatment group | Experimental | Other: Bobath Therapy | Bobath group received 45 min of sessions three times weekly for 12 weeks. |
| Control group | Active comparator | Other: Vojta technique | Vojta group received the following three times weekly for 12 weeks. |
- Bobath Therapy (Other): 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
- Vojta technique (Other): 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.
+Outcome measures
Primary outcomes
- Alberta Infant Motor Scale [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.
Secondary outcomes
- Beck Depression Scale [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.
- Nottingham Health Profile [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
+Eligibility
Sex: All, ages: 0 Months to 24 Months
Inclusion Criteria:
* being between 0 and 2 years
* being diagnosed with DS
Exclusion Criteria:
* having an additional neuro-motor disease
+Locations (1)
| Facility | City | Country | Status |
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| Pamukkale University | Denizli | Turkey (Türkiye) | |