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Pilates Exercises and Down Syndrome

Primary Purpose

Balance, Down Syndrome, Pilates Exercises

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
pilates exercises
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Balance

Eligibility Criteria

6 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty Of Physical TherapyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

conventional physical therapy

pilates exercises

Arm 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 attend the intervention program three times/week for 3 months

Outcomes

Primary Outcome Measures

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).
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.

Secondary Outcome Measures

Full Information

First Posted
June 25, 2023
Last Updated
June 25, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05928949
Brief Title
Pilates Exercises and Down Syndrome
Official Title
Effect of Pilates Exercises on Balance and Gross Motor Co-Ordination In Children With Down Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 26, 2023 (Anticipated)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
September 11, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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
Detailed 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Balance, Down Syndrome, Pilates Exercises

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
conventional physical therapy
Arm Type
Active Comparator
Arm 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.
Arm Title
pilates exercises
Arm Type
Experimental
Arm Description
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 attend the intervention program three times/week for 3 months
Intervention Type
Other
Intervention Name(s)
pilates exercises
Intervention Description
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.
Primary Outcome Measure Information:
Title
balance
Description
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).
Time Frame
3 months
Title
Bruininks-oseretsky test of motor proficiency-second version (BOT-2)
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alaa F AL-Nemr, Phd
Phone
01003727467
Email
alaaalnemr28@gmail.com
Facility Information:
Facility Name
Faculty Of Physical Therapy
City
Cairo
State/Province
الجيزه
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Faculty of physical therapy OP Therapy
Phone
01003727467
Email
alaaalnemr28@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Pilates Exercises and Down Syndrome

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