Effect of Neuro Developmental Therapy in Infants With Down Syndrome

NCT04816409 | Completed DMC

• 1 other identifier: REC/Lhr/19/1010 Raneem sajjad
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Down Syndrome

Keywords

Down syndrome; Children; Gross motor function; Neurodevelopmental treatment; Rehabilitation; Milestones; Postural reactions

Outcome Measures

Primary Outcomes (1)

• 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.

  2 months

Study Arms (2)

(Neurodevelopmental therapy)

EXPERIMENTAL

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

Conventional treatment

ACTIVE COMPARATOR

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

Interventions

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,

Conventional treatment

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

(Neurodevelopmental therapy)

Eligibility Criteria

• Age: 5 Months - 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Binash afzal

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (7)

• Angsupaisal M, Dijkstra LJ, la Bastide-van Gemert S, van Hoorn JF, Burger K, Maathuis CGB, Hadders-Algra M. Best seating condition in children with spastic cerebral palsy: One type does not fit all. Res Dev Disabil. 2017 Dec;71:42-52. doi: 10.1016/j.ridd.2017.09.016. Epub 2017 Oct 5.

  PMID: 28987971 BACKGROUND

• 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.

  PMID: 28755534 BACKGROUND

• 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.

  PMID: 29072042 BACKGROUND

• O'Callaghan FJ, Edwards SW, Alber FD, Hancock E, Johnson AL, Kennedy CR, Likeman M, Lux AL, Mackay M, Mallick AA, Newton RW, Nolan M, Pressler R, Rating D, Schmitt B, Verity CM, Osborne JP; participating investigators. Safety and effectiveness of hormonal treatment versus hormonal treatment with vigabatrin for infantile spasms (ICISS): a randomised, multicentre, open-label trial. Lancet Neurol. 2017 Jan;16(1):33-42. doi: 10.1016/S1474-4422(16)30294-0. Epub 2016 Nov 10.

  PMID: 27838190 BACKGROUND

• 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.

  PMID: 31113280 BACKGROUND

• 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.

  PMID: 31301057 BACKGROUND

• Savardi A, Borgogno M, Narducci R, La Sala G, Ortega JA, Summa M, Armirotti A, Bertorelli R, Contestabile A, De Vivo M, Cancedda L. Discovery of a Small Molecule Drug Candidate for Selective NKCC1 Inhibition in Brain Disorders. Chem. 2020 Aug 6;6(8):2073-2096. doi: 10.1016/j.chempr.2020.06.017.

  PMID: 32818158 BACKGROUND

MeSH Terms

Conditions

Down Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

• Binash Afzal, PHD*

  Riphah international university lahore campus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2021
• First Posted: March 25, 2021
• Study Start: March 15, 2019
• Primary Completion: November 20, 2019
• Study Completion: January 30, 2020
• Last Updated: March 30, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)