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

NCT07578922 | Recruiting DMC

• 1 other identifier: REC/RCR&AHS/24/Youkabad Khoula
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Down Syndrome

Keywords

Down syndrome, Balance, Gait, Bean Bag Tossing

Outcome Measures

Primary Outcomes (2)

• Static Balance

  To assess static balance before and after the intervention, the Berg Balance Scale (BBS) will be used to evaluate improvements in postural stability and functional balance. This method allows for the measurement of a child's ability to maintain equilibrium during a series of standardized tasks, such as standing unsupported, reaching forward, and maintaining different standing positions. Changes in the total BBS score will indicate improvements in balance performance, while task-specific scores may reflect enhanced control, coordination, and stability achieved through activities such as bean bag tossing on a wedge and balance board.

  Baseline, 4 weeks

• Dynamic Balance

  To assess dynamic balance before and after the intervention, the Gallop Scale will be used to evaluate improvements in coordinated movement and balance during locomotor activities. This method allows for the measurement of a child's ability to perform rhythmic and controlled galloping patterns, including step coordination, body alignment, and fluidity of movement. Changes in the Gallop Scale scores will indicate improvements in dynamic balance performance, while specific components of the assessment may reflect enhanced motor control, timing, and coordination developed through activities such as bean bag tossing on a wedge and balance board.

  Baseline, 4 weeks

Study Arms (2)

Bean Bag Tossing Game on Wedge.

EXPERIMENTAL

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 bag board one by one starting to stand on wedge from 5 minutes to increases the time to maximum 10minutes

Other: Bean Bag Tossing Game on Wedge

Bean Bag Tossing Game on Balance Board

OTHER

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 bean bags in the bean bag board one by one. Ask the child to maintain the balance while standing on balance board

Other: Bean Bag Tossing Game on Balance Board

Interventions

Bean Bag Tossing Game on Wedge OTHER

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 bag board one by one starting to stand on wedge from 5 minutes to increases the time to maximum 10minutes

Bean Bag Tossing Game on Wedge.

Bean Bag Tossing Game on Balance Board OTHER

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 bean bags in the bean bag board one by one. Ask the child to maintain the balance while standing on balance board

Bean Bag Tossing Game on Balance Board

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Imran Amjad

Lahore, Punjab Province, 05450, Pakistan

RECRUITING

Related Publications (1)

• 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 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

• Youkabad Khoula, MS-PT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Imran Amjad, PhD

CONTACT

9233224390125; imran.amjad@riphah.edu.pk

Muhammad Asif Javed, MS-PT

CONTACT

923224209422; a.javed@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will get separate treatment protocol, and possible efforts will be put to mask both groups about the treatment
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This randomized clinical trial will include 36 children (ages 5-17) with spastic cerebral palsy, toe walking, and balance deficits. Participants will be randomly assigned to two groups: Group A (n=18) will perform a Bean Bag Tossing Game on a wedge, and Group B (n=18) on a balance board. The intervention will be conducted 3 times per week for 4 weeks, 30 minutes per session. Eligible participants will be assessed, and informed consent will be obtained from guardians. Outcomes will be measured using the Berg Balance Scale and GALLOP Scale. Ethical approval will be sought from the Research Ethical Committee of Riphah International University Lahore. Data will be analyzed using SPSS version 27.0.

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 11, 2026
• Study Start: October 28, 2025
• Primary Completion: May 5, 2026
• Study Completion: June 15, 2026
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)