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Completed

NCT Number: NCT04816409

Effect of Neuro Developmental Therapy in Infants With Down Syndrome

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.

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Key information

Conditions

Down Syndrome Abnormalities, Multiple Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Intellectual Disability Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations

Age range

5 month–3 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Binash afzal

Lahore, Punjab Province, 54000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Conventional Therapy

Other

Range of motion and Resistance training Linear actions are used to regularize extensor muscle tone (Neck extensors, back extensors hip extensors, knee extensors).(49) Postural control exercises Bouncing on gym ball in sitting, kneeling, or standing

  • Linear swinging using a platform and swing, glider, hammock, and barrel; swinging in the kneeling, standing, sitting,

Neurodevelopmental therapy

Other

Starting Posture

  • Start and evaluate the supreme effective posture to move from(usually straight)
  • Reassemble to mid plane (head/trunk)
  • Neutral position of body (47) Identify the Missing Components Detect starting posture and compare to normal.(47)

Neurodevelopmental therapy application :

Tonic postural extensor muscle strengthening:

Push-pull scooter board games contrary to resistive tubing strips.(48) 2. Developmental movement patterns training: Obstacle crawl, hold swing's ropes in kneeling and half kneeling position, throw balls to aim kneeling and standing position. Manual Cues .Use hands on key points of control to assist normal posture, movement and prevent abnormal posture and movement. Balance and corrective reactions was established by means of ball and tilt board after the development of the skill of

li

Primary outcomes

  1. Gross Motor Function Measure-88(GMFM-88)

    Time frame: 2 months

    The GMFM-88 is the original 88-item measure. Items span the spectrum of gross motor activities in five dimensions. ... The GMFM-66 is a 66 item subset of the original 88 items identified through Rasch analysis to best describe the gross motor function of children with cerebral palsy of varying abilities.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effect of Neuro Developmental Therapy to Improve Postural Reactions and Motor Milestones in Infants With Down Syndrome

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Mar 25, 2021
Registry last updated
Mar 30, 2021

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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