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Completed

NCT Number: NCT04536506

Bobath and Vojta Therapy for DS

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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Key information

Conditions

Down Syndrome Abnormalities, Multiple Bobath Therapy Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Intellectual Disability Motor Performance Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Vojta Technique

Age range

0 month–24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pamukkale University

Denizli, 20070, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • being between 0 and 2 years
  • being diagnosed with DS

Exclusion criteria

  • having an additional neuro-motor disease

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

Sponsors and collaborators

Lead sponsor

Pamukkale University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Sep 2, 2020
Registry last updated
Sep 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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