Clinical trial NCT04816409: Effect of Neuro Developmental Therapy in Infants With Down Syndrome
Official title: Effect of Neuro Developmental Therapy to Improve Postural Reactions and Motor Milestones in Infants With Down Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Down Syndrome
Keywords: Down syndrome
Children
Gross motor function
Neurodevelopmental treatment
Rehabilitation
Milestones
Postural reactions
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2021-03-25
Enrollment: 20
Sex: ALL
Minimum age (years): 5
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Neurodevelopmental treatments are a progressive therapeutic method experienced thru qualified therapists for the improvement in affected ones. The most important trial in Down syndrome children is motor milestones and postural reactions to develop on time.

Neurodevelopmental therapy is applied to accurate atypical postural tone and to enable further regular motion for execution of presentation of abilities. Objective: To determine the effects of Neuro Developmental therapy in improving postural reaction and motor milestones in infants with Down syndrome.

Detailed description: This study was a randomized trial design. This study was conducted in Rehab Care Physiotherapy Department. 20 Children with Down syndrome meeting the predetermined inclusive and exclusive criteria were arbitrarily allocated into dual batches through convenient sampling technique. The first batch which was the experimental group was given Neurodevelopmental therapy and the duration of the treatment comprised of 1.5 hour, three days a week for 6 weeks. The second group which was the control group received conventional therapy and the period of the ministrations comprised of 1 hour, with 10 repetition 3 sets for each muscle three days a week for 1.5 months, Pre-assessment and post-assessment was evaluated through Gross motor function-88. Recorded values were analyzed through SPSS.

Eligibility criteria: Inclusion Criteria:

* Trisomy 21 by genetic karyotype.
* Down syndrome children with delayed milestone.
* Definite identification of Down syndrome by neurologist.
* Children having the average birth weight above 2.500 grams and average birth length above 49.52 cm.
* Laxity, low muscle tone and psychomotor development deficits

Exclusion Criteria:

* Infants with Heart Defect.
* Seizure.
* Critical orthopedic difficulties or deformities (hip instability, patellar instability, foot deformity).
* Unrestrained thyroid conflicts.
* Perilabour asphyxia (Apgar of minutes 1 and 5 equal to or less than 7).
* Critical optical or acoustic disorders.
* Mass below the 3rd percentage of Down syndrome

Primary outcomes:
measure: Gross Motor Function Measure-88(GMFM-88)
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Binash afzal
state: Punjab
Study officials:
affiliation: Riphah international university lahore campus
name: Binash Afzal, PHD*
role: PRINCIPAL_INVESTIGATOR
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