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Completed

NCT Number: NCT05969873

Effect Of Pilates On Postural Control And Balance In Children With Down's Syndrome

Down's syndrome (DS) is a genetic condition characterized by the presence of an extra chromosome 21, leading to various clinical symptoms. Individuals with DS often experience challenges in balance, posture, and motor skills, which can impact their daily activities. Pilates activities focus on the concept of control of muscles. Pilates increases trunk flexibility, abdominal and core strength and endurance, and deep core muscle activation hence improving balance and posture.

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Key information

Conditions

Down Syndrome Abnormalities, Multiple Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Intellectual Disability Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Riphah International University

Lahore, Punjab Province, 54000, Pakistan

About this study

The study will be randomized controlled trial used to evaluate the effectiveness of pilates on posture and balance in children with down's syndrome. Subjects with down's syndrome meeting the pre-detremined inclusion and exclusion criteria will be divided into two groups using non-probability sampling technique. Assessment will be done using Pediatric balance scale(PBS) and Timed up and go test (TUG).). Control group will receive regular physical therapy with balance training and experimental group will receive regular physical therapy+ Pilates.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Down's syndrome children with age between 6 and 12 years.
  • The ability to execute required motor skill proficiency and executive function tests.
  • The capacity to walk and stand by oneself

Exclusion criteria

  • • Children who are not able to comprehend commands.
  • Associated cardiovascular and orthopedic condition.
  • Loss of functional hearing and vision or a related respiratory disease.
  • History of traumatic injury
  • History of previous surgery
  • Inability of parents to understand the procedure and their unwillingness to participate

Treatment and study plan

pilates exercise

Other

Patients in this group will be treated with pilates exercise and conventional physical therapy as baseline treatment.

Other names: Experimental group

Balance training

Other

Patients in this group will be treated with balance training and conventional physical therapy as baseline treatment.

Other names: Control group

Primary outcomes

  1. Pediatric Balance Scale

    Time frame: 12 weeks

    This tool is used for assessing change from baseline. The PBBS is easy to administer, does not require specialized equipment, and can be completed in <20 minutes. A 0 to 4 grading scale provides a quantitative and qualitative measure of performance. It involves 14 mobility tasks, with the tasks varying in degrees of difficulty. The tasks are divided into 3 domains: sitting balance, standing balance, and dynamic balance. PBS has high validity and reliability of 0.98. 41-56= low fall risk, 21-40= medium fall risk, 0-20=high risk

Secondary outcomes

  1. Timed up and go test

    Time frame: 12 weeks

    TUG is a simple test used to assess a person's mobility and evaluate both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three meters, turns around 180 degrees, walk back to the chair and sit down while turning 180 degrees.

    Interpretation: ≤ 10 seconds= normal. A score of ≥ 14 seconds has been shown to indicate high risk of fall.

    ICC value for interrater reliability between 2 authors' TUG times for 20 randomly selected patients was .96.

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 1, 2023
Registry last updated
Dec 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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