Clinical trial NCT06732713: Swiss Ball Versus Frenkel Exercises Effects in Down Syndrome
Official title: Effects Of Swiss Ball Versus Frenkel Exercises on Static and Dynamic Balance in Children With Down Syndrome.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Down Syndrome
Keywords: Down Syndrome
Swiss ball
Frenkel exercises
Static balance
Dynamic balance
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-12-13
Enrollment: 32
Sex: ALL
Minimum age (years): 8
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The current study will be randomized clinical. The study will include 32 patients aged between 8 to 13 years equally divided into two groups and randomly allocated trial. Group A will perform Frenkel exercises and group B will perform Swiss ball exercises along routine physical therapy. Before and after intervention period, Static and dynamic balance will be assessed by Pediatric Balance Scale, Timed Up and Go test and Romberg test.
Primary purpose: OTHER

Brief summary: Down syndrome (or trisomy 21) is the most common genetic cause of intellectual disability, occurring in an estimated 1 in 800 births worldwide. Approximately 11,000 people with Down syndrome live in Australia and 250,000 in the USA. Individuals with Down syndrome present with several impairments such as hypotonia, ligament laxity, decreased muscle strength, insufficient muscular co-contraction, inadequate postural control, and disturbed proprioception. Frenkel exercises are a series of motions of increasing difficulty performed by patients to facilitate the restoration of balance and coordination. Frenkel exercises are used to bring back the rhythmic, smooth and movements. In recent years, Swiss Ball has been widely used as a new method of treatment to increase balance, strengthen core region of body muscles, and strengthen muscles that are effective in maintaining posture, coordination, and flexibility. The aim of this recent study is to compare the effects of two different therapeutic techniques i.e Frenkel versus Swiss ball exercises on static and dynamic balance in children with Down syndrome.

Detailed description: Down syndrome (or trisomy 21) is the most common genetic cause of intellectual disability, occurring in an estimated 1 in 800 births worldwide. Approximately 11,000 people with Down syndrome live in Australia and 250,000 in the USA. Individuals with Down syndrome present with several impairments such as hypotonia, ligament laxity, decreased muscle strength, insufficient muscular co-contraction, inadequate postural control, and disturbed proprioception. Frenkel exercises are a series of motions of increasing difficulty performed by patients to facilitate the restoration of balance and coordination. Frenkel exercises are used to bring back the rhythmic, smooth and movements. In recent years, Swiss Ball has been widely used as a new method of treatment to increase balance, strengthen core region of body muscles, and strengthen muscles that are effective in maintaining posture, coordination, and flexibility. The aim of this recent study is to compare the effects of two different therapeutic techniques i.e Frenkel versus Swiss ball exercises on static and dynamic balance in children with Down syndrome.

The current study will be randomized clinical trial, data will be collected from Children Hospital and Institute of Child Health, Lahore. The study will include 32 patients equally divided into two groups and randomly allocated. Inclusion criteria for the study will include patients diagnosed with Down syndrome, age between 8 to 13 years, patient able to understand instructions necessary for intervention, independent standing and walking abilities. Patient with any heart deficit, visual or hearing disorder, mobility impairment and instability of atlanto occipital joint will be excluded. Sample will be divided into two groups.

Group A will perform Frenkel exercises and group B will perform Swiss ball exercises along routine physical therapy. Before and after intervention period, Static and dynamic balance will be assessed by Pediatric Balance Scale, Timed Up and Go test and Romberg test. Data collection will be done before and after the intervention. Data will be analyzed through SPSS version 23.00.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with Down syndrome.
* Age between 8 to 13 years.
* Patient able to understand instructions necessary for intervention.
* Independent standing and walking abilities.
* Both the genders were included

Exclusion Criteria:

* Severe mental retardation.
* Any heart deficit.
* Visual impairments.
* Musculoskeletal or mobility disorder.
* Hearing impairements.
* Signs of epilepsy or instability of atlanto axial joint

Primary outcomes:
measure: Pediatric Balance Scale
timeFrame: 8 weeks
measure: Timed up and Go test
timeFrame: 8 weeks
measure: Romberg test
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Riphah International University
state: Punjab
Study officials:
affiliation: Riphah International University
name: Layba Marrium, MS*
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shields N. Physiotherapy management of Down syndrome. J Physiother. 2021 Oct;67(4):243-251. doi: 10.1016/j.jphys.2021.08.016. Epub 2021 Sep 10. No abstract available.