Bobath and Vojta Therapy for DS

Down Syndrome Clinical Trial

Official title:

Comparison of the Effectiveness of Bobath Therapy and Vojta Technique in Babies With Down Syndrome Aged 0-24 Months: A Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04536506
• Other study ID #: 60116787-020/66911
• Status: Completed
• Phase: N/A
• Start date: September 26, 2019
• Est. completion date: January 26, 2020

Study information

• Verified date: August 2020
• Source: Pamukkale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: January 26, 2020
• Est. primary completion date: December 26, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 24 Months

Eligibility

Inclusion Criteria:

• being between 0 and 2 years

• being diagnosed with DS

Exclusion Criteria:

• having an additional neuro-motor disease

Related Conditions & MeSH terms

• Bobath Therapy
• Down Syndrome
• Motor Performance
• Syndrome
• Vojta Technique

Intervention

Other:
• Bobath Therapy
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
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.

Locations

Country	Name	City	State
Turkey	Pamukkale University	Denizli

Sponsors (1)

Lead Sponsor	Collaborator
Pamukkale University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alberta Infant Motor Scale	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.	12 weeks
Secondary	Beck Depression Scale	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.	12 weeks
Secondary	Nottingham Health Profile	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	12 weeks