NCT04818437

Brief Summary

Children with Down syndrome often present with problems of posture \& balance and mobility. Balance training is an important component of physical activity interventions, with growing evidence that it can be beneficial for children with DS. Objective: To determine the effect core stability exercises and balance training in postural control among Down syndrome.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2020

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 26, 2021

Completed
Last Updated

March 30, 2021

Status Verified

March 1, 2021

Enrollment Period

3 months

First QC Date

March 24, 2021

Last Update Submit

March 29, 2021

Conditions

Down Syndrome

Keywords

Down syndromeCore stabilityPostural ControlPediatric Berg balance scale

Outcome Measures

Primary Outcomes (1)

  • Pediatric Berg balance scale

    The Pediatric Balance Scale is a modified version of the Berg Balance Scale that is used to assess functional balance skills in CP children . The scale consists of 14 items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points.

    2 months

Study Arms (2)

Balance training

EXPERIMENTAL

Balance training 1. Trunk, head, and upper limbs rotation from kneeling. 2. Upper limbs flexion and extension with simultaneous head movement from kneeling. 3. Pelvic bridging followed by raising one lower limb and extending knee. 4. Lifting opposite upper and lower limbs from Quadruped position. 6-Heel and toe raises, alternate rising ofthe right and left feet above the floor, and tandem standing. 7-Weight shifting forward. backward, sideward, and diagonally with eyes opened and eyes closed

Other: BALANCE TRAINING

Core stability exercise

ACTIVE COMPARATOR

Core stability exercises: 1. Abdominal bracing while lying in supine position. 2. Abdominal bracing with heel slide while lying in supine position. 3. Abdominal bracing with Leg lifts while lying in supine position. 4. Abdominal bracing with bridging while lying in supine position. 5. Abdominal bracing while Standing 6-Abdominal bracing while walking. 7-Quadra pod arm lifts with bracings while Quadra pod position. 8-Quadra pod alternate arm and leg lifts with bracing while Quadra pod position. 9-Side plank with knee flexion while side lying. 10-Side plank with knee extension while side lying.

Other: CORE STABILITY EXERCISES

Interventions

BALANCE TRAININGOTHER

Trunk, head, and upper limbs rotation from kneeling. 2- Upper limbs flexion and extension with simultaneous head movement from kneeling. 3-Pelvic bridging followed by raising one lower limb and extending knee. 4-Lifting opposite upper and lower limbs from Quadruped position. 6-Heel and toe raises, alternate rising of he right and left feet above the floor, and tandem standing. 7-Weight shifting forward. backward, sideward, and diagonally with eyes opened and eyes closed

Balance training
CORE STABILITY EXERCISESOTHER

1. Abdominal bracing while lying in supine position. 2. Abdominal bracing with heel slide while lying in supine position. 3. Abdominal bracing with Leg lifts while lying in supine position. 4. Abdominal bracing with bridging while lying in supine position. 5. Abdominal bracing while Standing.-Abdominal bracing while walking. 7-Quadra pod arm lifts with bracings while Quadra pod position. 8-Quadra pod alternate arm and leg lifts with bracing while Quadra pod position. 9-Side plank with knee flexion while side lying. 10-Side plank with knee extension while side lying

Core stability exercise

Eligibility Criteria

Age5 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Trisomy 21 by genetic karyotype
  • A confirmed diagnosis of Down syndrome by a paediatric neurologist, having no neurological or mobility disorders,
  • independent standing and walking abilities,
  • Joint Laxity , low muscle tone and psychomotor development deficits
  • Normal vision and hearing

You may not qualify if:

  • A history of congenital heart defects and orthopedic
  • surgery in the past year and severe mental retardation.
  • Seizure
  • Severe visual or auditory disturbances,
  • Weight less than the 3rd percentile of Down syndrome
  • Multiple sclerosis or epilepsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Binash afzal

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (10)

  • 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: 31301057BACKGROUND

  • Eid MA, Aly SM, Huneif MA, Ismail DK. Effect of isokinetic training on muscle strength and postural balance in children with Down's syndrome. Int J Rehabil Res. 2017 Jun;40(2):127-133. doi: 10.1097/MRR.0000000000000218.

    PMID: 28146007BACKGROUND

  • Zago M, Duarte NAC, Grecco LAC, Condoluci C, Oliveira CS, Galli M. Gait and postural control patterns and rehabilitation in Down syndrome: a systematic review. J Phys Ther Sci. 2020 Apr;32(4):303-314. doi: 10.1589/jpts.32.303. Epub 2020 Apr 2.

    PMID: 32273655BACKGROUND

  • Sugimoto D, Bowen SL, Meehan WP 3rd, Stracciolini A. Effects of Neuromuscular Training on Children and Young Adults with Down Syndrome: Systematic Review and Meta-Analysis. Res Dev Disabil. 2016 Aug;55:197-206. doi: 10.1016/j.ridd.2016.04.003. Epub 2016 Apr 25.

    PMID: 27123540BACKGROUND

  • Motealleh A, Mohamadi M, Moghadam MB, Nejati N, Arjang N, Ebrahimi N. Effects of Core Neuromuscular Training on Pain, Balance, and Functional Performance in Women With Patellofemoral Pain Syndrome: A Clinical Trial. J Chiropr Med. 2019 Mar;18(1):9-18. doi: 10.1016/j.jcm.2018.07.006. Epub 2019 Feb 10.

    PMID: 31193229BACKGROUND

  • Maiano C, Hue O, Lepage G, Morin AJS, Tracey D, Moullec G. Do Exercise Interventions Improve Balance for Children and Adolescents With Down Syndrome? A Systematic Review. Phys Ther. 2019 May 1;99(5):507-518. doi: 10.1093/ptj/pzz012.

    PMID: 31089706BACKGROUND

  • Capio CM, Mak TCT, Tse MA, Masters RSW. Fundamental movement skills and balance of children with Down syndrome. J Intellect Disabil Res. 2018 Mar;62(3):225-236. doi: 10.1111/jir.12458. Epub 2017 Dec 5.

    PMID: 29205624BACKGROUND

  • Silva V, Campos C, Sa A, Cavadas M, Pinto J, Simoes P, Machado S, Murillo-Rodriguez E, Barbosa-Rocha N. Wii-based exercise program to improve physical fitness, motor proficiency and functional mobility in adults with Down syndrome. J Intellect Disabil Res. 2017 Aug;61(8):755-765. doi: 10.1111/jir.12384. Epub 2017 Jun 6.

    PMID: 28585394BACKGROUND

  • Pena GM, Pavao SL, Oliveira MFP, Godoi D, de Campos AC, Rocha NACF. Dual-task effects on postural sway during sit-to-stand movement in children with Down syndrome. J Intellect Disabil Res. 2019 Jun;63(6):576-586. doi: 10.1111/jir.12599. Epub 2019 Jan 28.

    PMID: 30687997BACKGROUND

  • Saquetto MB, Pereira FF, Queiroz RS, da Silva CM, Conceicao CS, Gomes Neto M. Effects of whole-body vibration on muscle strength, bone mineral content and density, and balance and body composition of children and adolescents with Down syndrome: a systematic review. Osteoporos Int. 2018 Mar;29(3):527-533. doi: 10.1007/s00198-017-4360-1. Epub 2018 Jan 12.

    PMID: 29330572BACKGROUND

MeSH Terms

Conditions

Down Syndrome

Condition Hierarchy (Ancestors)

Intellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic 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
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2021

First Posted

March 26, 2021

Study Start

September 15, 2019

Primary Completion

December 20, 2019

Study Completion

March 30, 2020

Last Updated

March 30, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)