Menu
Recruiting NCT06732713

Swiss Ball Versus Frenkel Exercises Effects in Down Syndrome

No phase Interventional Down Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Swiss Ball, Frenkel exercise.
Who it may be relevant to
Registry conditions: Down Syndrome. Basic parameters: 8 years — 13 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effects Of Swiss Ball Versus Frenkel Exercises on Static and Dynamic Balance in Children With Down Syndrome.

Overview

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.

Interventions

  • Other Swiss Ball
    Swiss ball exercises will be performed in supine, sitting and standing position for about 25 to 30 minutes , 3 to 4 sessions per week for 8 weeks
  • Other Frenkel exercise
    Frenkel exercises will be performed in supine, sitting and standing position for about 25 to 30 minutes, 3 to 4 sessions per week for 8 weeks

Primary outcome measures

  • Pediatric Balance Scale [Time frame: 8 weeks]
  • Timed up and Go test [Time frame: 8 weeks]
  • Romberg test [Time frame: 8 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Other

Study locations

Pakistan · 1 center
  • Riphah International University — Lahore

Publications

  • 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. PMID 34511385

Identifiers

NCT: NCT06732713 · REC/RCR & AHS/24/0710

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗