Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04818437
Other study ID # REC/Lhr/19/1012 Hunza Zulfiqar
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 15, 2019
Est. completion date March 30, 2020

Study information

Verified date March 2021
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date March 30, 2020
Est. primary completion date December 20, 2019
Accepts healthy volunteers No
Gender All
Age group 5 Years to 17 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
BALANCE TRAINING
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
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.-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

Locations

Country Name City State
Pakistan Binash afzal Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & 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. — View 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. — View 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. — View Citation

Maïano 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. — View 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. — View Citation

Pena GM, Pavão 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. — View Citation

Saquetto MB, Pereira FF, Queiroz RS, da Silva CM, Conceição 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. — View Citation

Silva V, Campos C, Sá A, Cavadas M, Pinto J, Simões P, Machado S, Murillo-Rodríguez 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. — View 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. Review. — View 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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
See also
  Status Clinical Trial Phase
Recruiting NCT04854122 - Blood Flow Regulation in Individuals With Down Syndrome - Training Study N/A
Completed NCT04020302 - Self-Monitoring Shopping Intervention N/A
Recruiting NCT01950624 - DS-Connect {TM}: The Down Syndrome Registry
Completed NCT04751136 - the Effect of Cerebrolysin on Physical and Mental Functions of Down Syndrome Phase 2
Completed NCT04767412 - Inspiratory Muscle Training and Physical Fitness in Children With Down Syndrome Randomized Control Trial N/A
Not yet recruiting NCT04037579 - Protocol for a Non-randomized Survey in Down Syndrome People Who Practice Sports. Self and Observers´ Perception.
Completed NCT04536506 - Bobath and Vojta Therapy for DS N/A
Completed NCT02882698 - Performance Analysis in Down Syndrome on Mobile Phone N/A
Completed NCT01791725 - A 4-Week Safety Study of Oral ELND005 in Young Adults With Down Syndrome Without Dementia Phase 2
Unknown status NCT01975545 - Fluor Varnish With Silver Nanoparticles for Dental Remineralization in Patients With Trisomy 21 Phase 2
Completed NCT01808508 - Obstructive Sleep Apnea and Neurocognitive and Cardiovascular Function in Children With Down Syndrome N/A
Terminated NCT00754052 - Evaluating The Efficacy And Safety Of Donepezil Hydrochloride (Aricept) In The Treatment Of The Cognitive Dysfunction Exhibited By Children With Down Syndrome, Aged 11 To 17 Phase 3
Terminated NCT00754013 - Evaluating The Efficacy And Safety Of Donepezil Hydrochloride (Aricept) In The Treatment Of The Cognitive Dysfunction Exhibited By Children With Down Syndrome, Aged 6 To 10 Phase 3
Completed NCT01256112 - Parent Supported Weight Reduction in Down Syndrome N/A
Completed NCT01313325 - Hippotherapy to Improve the Balance of Children With Movement Disorders N/A
Completed NCT01594346 - Multicenter Vitamin E Trial in Aging Persons With Down Syndrome Phase 3
Completed NCT05343468 - Life Skills Improved in Children With Down Syndrome After Using Assistive Technology N/A
Suspended NCT05755464 - Evaluation of Patients With Down Syndrome Compliance to Dental Therapy
Recruiting NCT04022460 - Using Personal Mobile Technology to Identify Obstructive Sleep Apnea in Children With Down Syndrome (UPLOAD)
Completed NCT03192540 - The Impact of an 8-week Supported Exercise Program on Fitness and Symptoms in Adolescents With Down Syndrome N/A