- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: IMRAN AMJAD, PhD
- Telefonnummer: 9233224390125
- E-post: IMRAN.AMJAD@RIPHAH.EDU.PK
Studer Kontakt Backup
- Navn: Muhammad Asif Javed, MS-PT
- Telefonnummer: 923224209422
- E-post: a.javed@riphah.edu.pk
Studiesteder
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan, 05450
- Rekruttering
- Imran Amjad
-
Ta kontakt med:
- IMRAN AMJAD, PhD
- Telefonnummer: 9233224390125
- E-post: IMRAN.AMJAD@RIPHAH.EDU.PK
-
Ta kontakt med:
- Muhammad Asif Javed, MS-PT
- Telefonnummer: 923224209422
- E-post: a.javed@riphah.edu.pk
-
Hovedetterforsker:
- Youkabad Khoula, MS-PT
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
Tar imot friske frivillige
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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
|
|
Annen: 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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Static Balance
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Youkabad Khoula, MS-PT, Riphah International University
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- REC/RCR&AHS/24/Youkabad Khoula
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