- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07578922
Effects of Bean Bag Tossing Game on Balance and Gait in Children With Down Syndrome.
Effects of Bean Bag Tossing Game Using Static and Dynamic Surface on Balance and Gait in Children With Down Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: IMRAN AMJAD, PhD
- Phone Number: 9233224390125
- Email: imran.amjad@riphah.edu.pk
Study Contact Backup
- Name: Muhammad Asif Javed, MS-PT
- Phone Number: 923224209422
- Email: a.javed@riphah.edu.pk
Study Locations
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan, 05450
- Recruiting
- Imran Amjad
-
Contact:
- IMRAN AMJAD, PhD
- Phone Number: 9233224390125
- Email: imran.amjad@riphah.edu.pk
-
Contact:
- Muhammad Asif Javed, MS-PT
- Phone Number: 923224209422
- Email: a.javed@riphah.edu.pk
-
Principal Investigator:
- Youkabad Khoula, MS-PT
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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 bag board one by one starting to stand on wedge from 5 minutes to increases the time to maximum 10minutes
|
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 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 bean bags in the bean bag board one by one.
Ask the child to maintain the balance while standing 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 bean bags in the bean bag board one by one.
Ask the child to maintain the balance while standing on balance board
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline, 4 weeks
|
|
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.
|
Baseline, 4 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Youkabad Khoula, MS-PT, Riphah International University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR&AHS/24/Youkabad Khoula
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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