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.

Study Overview

• Status: Completed
• Conditions: Down Syndrome
• Intervention / Treatment: Other: Pilates exercise; Other: Balance training

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 22
• 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; Phone Number: 923224209422; Email: a.javed@riphah.edu.pk

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan, 54000
      • Riphah International University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pilates Group; In this group patients will be treated with physical therapy treatment pilates exercise. Group A underwent 45 minutes of Pilates exercises in addition to the identical exercise programme as group A to improve the strength, coordination and flexibility of the lower limbs. Pilates movements were carried out ten times, with a two-minute break in between each repetition. For six weeks, both groups participated in the intervention programme three times per week. Starting the programme off with supine exercises of segmental motions that include using the trunk muscles to maintain a neutral posture is normal. To enhance shoulder girdle control, supine arm workouts were gradually added. The spine's ability to flex and extend was steadily increased.	Other: Pilates exercise; Patients in this group will be treated with pilates exercise and conventional physical therapy as baseline treatment.; Other Names: Experimental group
Active Comparator: Balance training group; In this group patients will be treated with PT treatment with balance training. Exercises for stability of posture on numerous surfaces and positions were performed by Group B, including exercises for the flexors and adductors of hip, flexors and extensors of knee, and calf muscle (15-second hold and five repetitions) for improving their flexibility. The lower extremity and trunk muscles were the focus of Group B. The postural control exercise included walking in every direction, moving past the point of stability in various postures like half-kneeling, standing on hard and soft surfaces, stepping down and up, walking and standing at the same time, and one leg standing with eyes open and closed. Each session started with a 5-minute warm-up and ended with a 5-minute cool-down in between each phase.	Other: Balance training; Patients in this group will be treated with balance training and conventional physical therapy as baseline treatment.; Other Names: Control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pediatric Balance Scale	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	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Timed up and go test	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.	12 weeks

Collaborators and Investigators

• Sponsor: Riphah International University
• Investigators: Principal Investigator: Rida Khawar Dar, MS*, Riphah International University

Publications and helpful links

General Publications

• Abd-Elfattah HM, Galal DOSM, Aly MIE, Aly SM, Elnegamy TE. Effect of Pilates Exercises on Standing, Walking, and Balance in Children With Diplegic Cerebral Palsy. Ann Rehabil Med. 2022 Feb;46(1):45-52. doi: 10.5535/arm.21148. Epub 2022 Feb 28. Erratum In: Ann Rehabil Med. 2022 Apr;46(2):110.

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2023
• Primary Completion (Actual): November 1, 2023
• Study Completion (Actual): November 15, 2023

Study Registration Dates

• First Submitted: July 23, 2023
• First Submitted That Met QC Criteria: July 23, 2023
• First Posted (Actual): August 1, 2023

Study Record Updates

• Last Update Posted (Estimated): December 27, 2023
• Last Update Submitted That Met QC Criteria: December 26, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Balance; Down syndrome; Pilates; Contrology; Pediatric Balance Scale
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Disease; Congenital Abnormalities; Genetic Diseases, Inborn; Intellectual Disability; Abnormalities, Multiple; Chromosome Disorders; Syndrome; Down Syndrome
• Other Study ID Numbers: REC/RCR & AHS/23/0727

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No