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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05969873
Other study ID # REC/RCR & AHS/23/0727
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 16, 2023
Est. completion date November 15, 2023

Study information

Verified date December 2023
Source Riphah International University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date November 15, 2023
Est. primary completion date November 1, 2023
Accepts healthy volunteers No
Gender All
Age group 6 Years to 12 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Pilates exercise
Patients in this group will be treated with pilates exercise and conventional physical therapy as baseline treatment.
Balance training
Patients in this group will be treated with balance training and conventional physical therapy as baseline treatment.

Locations

Country Name City State
Pakistan Riphah International University Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
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