Effect of Neuro Developmental Therapy in Infants With Down Syndrome

March 29, 2021 updated by: Riphah International University

Effect of Neuro Developmental Therapy to Improve Postural Reactions and Motor Milestones 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54000
        • Binash Afzal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 months to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: (Neurodevelopmental therapy)

Starting Posture Start and evaluate the supreme effective posture to move from(usually straight) Reassemble to mid plane (head/trunk)

•Neutral position of body Identify the Missing Components Detect starting posture and compare to normal.

Neurodevelopmental therapy application :

Tonic postural extensor muscle strengthening:

Push-pull scooter board games contrary to resistive tubing strips.

Developmental movement patterns training:

Obstacle crawl, hold swing's ropes in kneeling anhalf 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 sustaining exercise positions in children.4. Ambulation training, suitable to the motor
Other: Neurodevelopmental therapy

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
Active Comparator: Conventional treatment
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,
Other: conventional therapy

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,

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2019

Primary Completion (Actual)

November 20, 2019

Study Completion (Actual)

January 30, 2020

Study Registration Dates

First Submitted

March 24, 2021

First Submitted That Met QC Criteria

March 24, 2021

First Posted (Actual)

March 25, 2021

Study Record Updates

Last Update Posted (Actual)

March 30, 2021

Last Update Submitted That Met QC Criteria

March 29, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/Lhr/19/1010 Raneem sajjad

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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