NCT04536506

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 26, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 26, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 26, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 28, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 2, 2020

Completed
Last Updated

September 2, 2020

Status Verified

August 1, 2020

Enrollment Period

3 months

First QC Date

August 28, 2020

Last Update Submit

August 28, 2020

Conditions

Keywords

infant with Down SyndromeBobath therapyVojta technique

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Beck Depression Scale

    12 weeks

  • Nottingham Health Profile

    12 weeks

Study Arms (2)

Treatment group

EXPERIMENTAL

Bobath group received 45 min of sessions three times weekly for 12 weeks.

Other: Bobath Therapy

Control group

ACTIVE COMPARATOR

Vojta group received the following three times weekly for 12 weeks.

Other: Vojta technique

Interventions

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

Treatment group

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.

Control group

Eligibility Criteria

Age0 Months - 24 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • having an additional neuro-motor disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamukkale University

Denizli, 20070, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Down Syndrome

Condition Hierarchy (Ancestors)

Intellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, Inborn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research assistant

Study Record Dates

First Submitted

August 28, 2020

First Posted

September 2, 2020

Study Start

September 26, 2019

Primary Completion

December 26, 2019

Study Completion

January 26, 2020

Last Updated

September 2, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations