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Effect of Core Stability Exercises and Balance Training in Postural Control Among Down Syndrome

Primary Purpose

Down Syndrome

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
BALANCE TRAINING
CORE STABILITY EXERCISES
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, Core stability, Postural Control, Pediatric Berg balance scale

Eligibility Criteria

5 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Binash afzal

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Balance training

Core stability exercise

Arm Description

Balance training Trunk, head, and upper limbs rotation from kneeling. Upper limbs flexion and extension with simultaneous head movement from kneeling. Pelvic bridging followed by raising one lower limb and extending knee. 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

Core stability exercises: Abdominal bracing while lying in supine position. Abdominal bracing with heel slide while lying in supine position. Abdominal bracing with Leg lifts while lying in supine position. Abdominal bracing with bridging while lying in supine position. 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.

Outcomes

Primary Outcome Measures

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.

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
NCT04818437
Brief Title
Effect of Core Stability Exercises and Balance Training in Postural Control Among Down Syndrome
Official Title
Effect of Core Stability Exercises and Balance Training in Postural Control Among Down Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
September 15, 2019 (Actual)
Primary Completion Date
December 20, 2019 (Actual)
Study Completion Date
March 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
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.
Detailed Description
This study was a randomized clinical trail. Children with Down Syndrome were determined on inclusion & exclusion criteria. Children with Down syndrome were arbitrarily allocated into two groups with ages ranged from 5 to 17 years. The sample size was 20 patients. They were assigned randomly into two groups. Group 1 received balance training and Group 2 received core stability exercises. The duration of treatment was 6 weeks. Data is collected from Comprehensive Rehabilitation center Chakwal Postural stability was evaluated pre and post treatment by pediatric berg balance scale. Values which were obtained after this intervention were analyzed for any change using 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, Core stability, Postural Control, Pediatric Berg balance scale

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Balance training
Arm Type
Experimental
Arm Description
Balance training Trunk, head, and upper limbs rotation from kneeling. Upper limbs flexion and extension with simultaneous head movement from kneeling. Pelvic bridging followed by raising one lower limb and extending knee. 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
Arm Title
Core stability exercise
Arm Type
Active Comparator
Arm Description
Core stability exercises: Abdominal bracing while lying in supine position. Abdominal bracing with heel slide while lying in supine position. Abdominal bracing with Leg lifts while lying in supine position. Abdominal bracing with bridging while lying in supine position. 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.
Intervention Type
Other
Intervention Name(s)
BALANCE TRAINING
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
CORE STABILITY EXERCISES
Intervention Description
Abdominal bracing while lying in supine position. Abdominal bracing with heel slide while lying in supine position. Abdominal bracing with Leg lifts while lying in supine position. Abdominal bracing with bridging while lying in supine position. 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
Primary Outcome Measure Information:
Title
Pediatric Berg balance scale
Description
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.
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
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
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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PubMed Identifier
28146007
Citation
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.
Results Reference
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PubMed Identifier
32273655
Citation
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.
Results Reference
background
PubMed Identifier
27123540
Citation
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.
Results Reference
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PubMed Identifier
31193229
Citation
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.
Results Reference
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PubMed Identifier
31089706
Citation
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.
Results Reference
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PubMed Identifier
29205624
Citation
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.
Results Reference
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PubMed Identifier
28585394
Citation
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.
Results Reference
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PubMed Identifier
30687997
Citation
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.
Results Reference
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PubMed Identifier
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Citation
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.
Results Reference
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Effect of Core Stability Exercises and Balance Training in Postural Control Among Down Syndrome

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