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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05928949
Other study ID # P.T.REC/012/003399
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 26, 2023
Est. completion date September 11, 2023

Study information

Verified date January 2023
Source Cairo University
Contact Alaa F AL-Nemr, Phd
Phone 01003727467
Email alaaalnemr28@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Down syndrome is one of the genetic disorders that affect postural control and balance in children. Balance involves controlling the position of the body in space to achieve stability and orientation. pilates exercises are one of several techniques that are used to improve balance and postural control in adults and children. the purpose of the study is To investigate the effect of Pilates exercises on balance and gross motor co-ordination in children with Down syndrome


Description:

Group A performed flexibility, strength, and endurance exercises that focused on the lower extremity and trunk muscles, exercise for postural stability in various positions and surfaces, including flexibility exercises for the hip, knee and calf muscle. Strengthening exercises included the core muscles, hip abductors, hip extensors hamstrings and quadriceps knee extension in high sitting. Postural control involved walking in all directions, exceeding the limits of stability in various positions such as kneeling, half kneeling, standing on rough and soft surfaces, Each session started with a warming up and cooling down of 5 minutes for each period and each session lasted for 45 minutes. Group B received the same program of exercises given to group A in addition to 45 minutes of Pilates exercises to improve balance and gross motor coordination. Exercises were performed on a mat, a medical ball, and from a standing position, focusing on maintaining core contraction, spinal and pelvic alignment, and respiration rhythm. Ten repetitions of Pilates exercises will be performed with a 2-minute rest period between repetitions. Both groups will attended the intervention program three times/week for 3 months


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date September 11, 2023
Est. primary completion date August 1, 2023
Accepts healthy volunteers No
Gender All
Age group 6 Years to 10 Years
Eligibility Inclusion Criteria: - (1) diagnosed with Trisomy 21 through genetic testing, (2) aged 6 to 11 years and (3) able to follow a minimum of two-step instructions. The minimum motor ability of participants with DS was independent locomotion. Exclusion Criteria: - (1) medical condition that is contraindicated to moderate to vigorous physical activity such as cardiovascular problems, (2) orthopaedic instability, including those associated with DS (e.g. atlanto-axial instability) and (3) behavioural issues that hindered instruction.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
pilates exercises
Pilates is a system of repetitive exercises performed on a yoga mat or other equipment to promote strength, stability, and flexibility. Pilates exercises develop the body through muscular effort that stems from the core.

Locations

Country Name City State
Egypt Faculty Of Physical Therapy Cairo ??????

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary balance Balance assessment will be performed in both groups before and after the intervention to find any significant difference, by using the Biodex Balance System to evaluate all measurable variables of stability indices (anteroposterior stability index and mediolateral stability index). 3 months
Primary Bruininks-oseretsky test of motor proficiency-second version (BOT-2) BOT-2 measures gross motor proficiency, with subtests that focus on stability, mobility, strength, coordination, and object manipulation. The test is tailored to school-aged children, who have varying motor control abilities ranging from normal to mild or moderate. In this study, it will be used to measure gross motor co-ordination. 3 months
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