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Recruiting NCT07578922

Effects of Bean Bag Tossing Game on Balance and Gait in Children With Down Syndrome.

No phase Interventional Down Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Bean Bag Tossing Game on Wedge, Bean Bag Tossing Game on Balance Board.
Who it may be relevant to
Registry conditions: Down Syndrome. Basic parameters: 5 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effects of Bean Bag Tossing Game Using Static and Dynamic Surface on Balance and Gait in Children With Down Syndrome

Overview

The research design will be a randomized clinical trial. The study will recruit 36 children with spastic cerebral palsy and toe walking that fall within the ages of 5-17 years who have a defined balance deficit. The participants will be randomly assigned to one of two groups: group A (n=18), which will play the Bean Bag Tossing Game on Wedge, and group B (n=18), which will play the Bean Bag Tossing Game on a Balance Board. The intervention will be performed 3 times a week for 4 weeks 30 minutes a day. All participants will be assessed according to eligibility criteria. Guardians of participants who meet the eligibility criteria are requested to sign consent forms before they are entered into the study. The study involves two standardized assessment tools that measure the Gait and balance in children with Down syndrome: Berg Balance Scale and GALLOP Scale. The synopsis will present to the Research Ethical Committee of Riphah International University Lahore for ethical approval to conduct this study. Data will be analyzed by SPSS 27.0 version

Detailed description

Down syndrome is a genetic condition where people are born with an extra chromosome.

Normally people have 23 pairs of chromosomes i.e. 46 chromosomes. People born with Down syndrome have an extra pair of chromosome i.e. 47 chromosomes. Women who are 35 years or older are more likely to have a child born with Down syndrome. To address this problem, the study will examine the effects of "Bean Bag Tossing Game and Balance Board" on Balance and Gait in children with Down syndrome. Children with Down syndrome have low tone i.e. hypotonia and joint laxity due to which they have balance problems which may lead to gait impairments. Bean bag tossing activities involve throwing and catching so it may alter children's balance by increasing coordination, postural awareness, and dynamic stability. Bean bag on the head or other body parts trains children to be aware of their posture and body alignment, which improves balance control. Tossing and collecting bean bags while moving about requires children to dynamically change their balance, which improves their ability to maintain balance while moving.

The research design will be a randomized clinical trial. The study will recruit 36 children with spastic cerebral palsy and toe walking that fall within the ages of 5-17 years who have a defined balance deficit. The participants will be randomly assigned to one of two groups: group A (n=18), which will play the Bean Bag Tossing Game on Wedge, and group B (n=18), which will play the Bean Bag Tossing Game on a Balance Board. The intervention will be performed 3 times a week for 4 weeks 30 minutes a day. All participants will be assessed according to eligibility criteria. Guardians of participants who meet the eligibility criteria are requested to sign consent forms before they are entered into the study. The study involves two standardized assessment tools that measure the Gait and balance in children with Down syndrome: Berg Balance Scale and GALLOP Scale. The synopsis will present to the Research Ethical Committee of Riphah International University Lahore for ethical approval to conduct this study. Data will be analyzed by SPSS 27.0 version.

Interventions

  • Other Bean Bag Tossing Game on Wedge
    In this group first the Children will be given the baseline therapy of backward walking for 10 minutes, single leg standing, vertical or horizontal jumps for 10 minutes and then given the balance training by playing bean bag tossing game while standing on wedge. Bean bag boards should be placed 1 foot apart from the tossing line. Use a rope (or another object) to mark the tossing line. The child will take 3 bean bags while standing on the wedge and ask the child to toss the bean bags in the bean
  • Other Bean Bag Tossing Game on Balance Board
    In this group first the Children will be given the baseline therapy of backward walking for 10 minutes, single leg standing, vertical or horizontal jumps for 10 minutes (18) and then given the balance training by playing bean bag tossing game while standing on a balance board. Bean bag boards should be placed 1 foot apart from the tossing line. Use a rope (or another object) to mark the tossing line. The child will take 3 bean bags while standing on a balance board and ask the child to toss the

Primary outcome measures

  • Static Balance [Time frame: Baseline, 4 weeks]
  • Dynamic Balance [Time frame: Baseline, 4 weeks]

Eligibility criteria

Inclusion criteria

  • Ageof7-12years
  • Abletorecognize the command given to them
  • Understand the verbal command
  • Standand walk independently without repeated falling
  • Normalvisualization and Audible range

Exclusion criteria

  • Children suffering from seizures
  • Children with Multiple Sclerosis
  • Children with Muscular Dystrophy
  • Children with cardiac anomalies

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Other

Study locations

Pakistan · 1 center
  • Imran Amjad — Lahore

Publications

  • Jain PD, Nayak A, Karnad SD, Doctor KN. Gross motor dysfunction and balance impairments in children and adolescents with Down syndrome: a systematic review. Clin Exp Pediatr. 2022 Mar;65(3):142-149. doi: 10.3345/cep.2021.00479. Epub 2021 Jun 11. PMID 34126707

Identifiers

NCT: NCT07578922 · REC/RCR&AHS/24/Youkabad Khoula

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗