Down SyndromeNCT07578922
Effects of Bean Bag Tossing Game on Balance and Gait in Children With Down Syndrome.
A study testing Bean Bag Tossing Game on Wedge and Bean Bag Tossing Game on Balance Board in people with Down Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Down Syndrome
- What is being tested?
- Bean Bag Tossing Game on Wedge and Bean Bag Tossing Game on Balance Board
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 sitePakistan
- Study dates
- 28 Oct 2025to 15 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Ageof7-12years
- Abletorecognize the command given to them
- Understand the verbal command
- Standand walk independently without repeated falling
- Normalvisualization and Audible range
Who cannot join
- Children suffering from seizures
- Children with Multiple Sclerosis
- Children with Muscular Dystrophy
- Children with cardiac anomalies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Bean Bag Tossing Game Using Static and Dynamic Surface on Balance and Gait in Children With Down Syndrome
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
Read the 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.
- Conditions
- Down Syndrome
- Being tested
- Bean Bag Tossing Game on Wedge, Bean Bag Tossing Game on Balance Board
- Keywords
- Down Syndrome, Balance, Gait, Bean Bag Tossing, Balance Board, Wedge, Motor Skills, Postural Control, Physiotherapy, Dynamic Balance
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bean Bag Tossing Game on WedgeOther
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 Balance BoardOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Bean Bag Tossing Game on Balance Board |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2026
- Study start28 Oct 2025
- Primary completion5 May 2026
- Study completion15 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Down SyndromeStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Youkabad Khoula, MS-PT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07578922
- Sponsor's protocol ID
- REC/RCR&AHS/25/0716
- Status last verified
- Sep 2026
- First submitted
- 5 May 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 34126707
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Bean Bag Tossing Game Using Static and Dynamic Surface on Balance and Gait in Children With Down Syndrome
- ClinicalTrials.gov ID
- NCT07578922
- Acronym / sponsor ID
- REC/RCR&AHS/25/0716
- Conditions
- Down Syndrome
- Keywords
- Down Syndrome, Balance, Gait, Bean Bag Tossing, Balance Board, Wedge, Motor Skills, Postural Control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 28 Oct 2025 (actual)
- Primary completion
- 5 May 2026 (actual)
- Study completion
- 15 Jun 2026 (actual)
- First posted
- 11 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Bean Bag Tossing Game on Wedge. | Experimental | Other: Bean Bag Tossing Game on WedgeIn 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 Balance Board | Other | Other: Bean Bag Tossing Game on Balance BoardIn 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 |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Ageof7-12years
- Abletorecognize the command given to them
- Understand the verbal command
- Standand walk independently without repeated falling
- Normalvisualization and Audible range
Key exclusion criteria (4 listed)
- Children suffering from seizures
- Children with Multiple Sclerosis
- Children with Muscular Dystrophy
- Children with cardiac anomalies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bean Bag Tossing Game on WedgeIn 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 BoardIn 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 |
Primary outcome
Static Balance
Time frame: Baseline, 4 weeks
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.
Dynamic Balance
Time frame: Baseline, 4 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
- Background: PubMed 34126707Jain 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Youkabad Khoula, MS-PT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bean Bag Tossing Game on Wedge and Bean Bag Tossing Game on Balance Board in people with Down Syndrome, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Static Balance (time frame: Baseline, 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07578922, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.