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Effect of Neuro Developmental Therapy in Infants With Down Syndrome

Primary Purpose

Down Syndrome

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
conventional therapy
Neurodevelopmental therapy
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Down Syndrome focused on measuring Down syndrome, Children, Gross motor function, Neurodevelopmental treatment, Rehabilitation, Milestones, Postural reactions

Eligibility Criteria

5 Months - 3 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Binash afzal

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

(Neurodevelopmental therapy)

Conventional treatment

Arm Description

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

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,

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 24, 2021
Last Updated
March 29, 2021
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT04816409
Brief Title
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

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
March 15, 2019 (Actual)
Primary Completion Date
November 20, 2019 (Actual)
Study Completion Date
January 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Down Syndrome
Keywords
Down syndrome, Children, Gross motor function, Neurodevelopmental treatment, Rehabilitation, Milestones, Postural reactions

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
(Neurodevelopmental therapy)
Arm Type
Experimental
Arm Description
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
Arm Title
Conventional treatment
Arm Type
Active Comparator
Arm Description
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,
Intervention Type
Other
Intervention Name(s)
conventional therapy
Intervention Description
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,
Intervention Type
Other
Intervention Name(s)
Neurodevelopmental therapy
Intervention Description
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 Outcome Measure Information:
Title
Gross Motor Function Measure-88(GMFM-88)
Description
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.
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Months
Maximum Age & Unit of Time
3 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Binash Afzal, PHD*
Organizational Affiliation
Riphah international university lahore campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Binash afzal
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28987971
Citation
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Results Reference
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28755534
Citation
Valentin-Gudiol M, Mattern-Baxter K, Girabent-Farres M, Bagur-Calafat C, Hadders-Algra M, Angulo-Barroso RM. Treadmill interventions in children under six years of age at risk of neuromotor delay. Cochrane Database Syst Rev. 2017 Jul 29;7(7):CD009242. doi: 10.1002/14651858.CD009242.pub3.
Results Reference
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PubMed Identifier
29072042
Citation
Mura G, Carta MG, Sancassiani F, Machado S, Prosperini L. Active exergames to improve cognitive functioning in neurological disabilities: a systematic review and meta-analysis. Eur J Phys Rehabil Med. 2018 Jun;54(3):450-462. doi: 10.23736/S1973-9087.17.04680-9. Epub 2017 Oct 25.
Results Reference
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PubMed Identifier
27838190
Citation
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Results Reference
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PubMed Identifier
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Citation
Armstrong D, Said RR. Outcomes of High-Dose Steroid Therapy for Infantile Spasms in Children With Trisomy 21. J Child Neurol. 2019 Oct;34(11):646-652. doi: 10.1177/0883073819850650. Epub 2019 May 22.
Results Reference
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PubMed Identifier
31301057
Citation
Alsakhawi RS, Elshafey MA. Effect of Core Stability Exercises and Treadmill Training on Balance in Children with Down Syndrome: Randomized Controlled Trial. Adv Ther. 2019 Sep;36(9):2364-2373. doi: 10.1007/s12325-019-01024-2. Epub 2019 Jul 12.
Results Reference
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Results Reference
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Effect of Neuro Developmental Therapy in Infants With Down Syndrome

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