Back to resultsEffect Of Pilates On Postural Control And Balance In Children With Down's Syndrome
Primary Purpose
Down Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Pilates exercise
Balance training
Sponsored by
About this trial
This is an interventional treatment trial for Down Syndrome focused on measuring Balance, Contrology, Down syndrome, Pilates, Pediatric Balance Scale
Eligibility Criteria
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
Sites / Locations
- Riphah International UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Pilates Group
Balance training group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT05969873
First Posted
July 23, 2023
Last Updated
July 23, 2023
Sponsor
Riphah International University
1. Study Identification
Unique Protocol Identification Number
NCT05969873
Brief Title
Effect Of Pilates On Postural Control And Balance In Children With Down's Syndrome
Official Title
Effect Of Pilates On Postural Control And Balance In Children With Down's Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 16, 2023 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Down Syndrome
Keywords
Balance, Contrology, Down syndrome, Pilates, Pediatric Balance Scale
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model 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.
Masking
Participant
Masking Description
Participants will get separate treatment protocols and possible efforts will be put to mask the both groups about their treatment.
Allocation
Randomized
Enrollment
22 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pilates Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Balance training group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Pilates exercise
Other Intervention Name(s)
Experimental group
Intervention Description
Patients in this group will be treated with pilates exercise and conventional physical therapy as baseline treatment.
Intervention Type
Other
Intervention Name(s)
Balance training
Other Intervention Name(s)
Control group
Intervention Description
Patients in this group will be treated with balance training and conventional physical therapy as baseline treatment.
Primary Outcome Measure Information:
Title
Pediatric Balance Scale
Description
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
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Timed up and go test
Description
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.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Imran Amjad, PhD
Phone
9233224390125
Email
imran.amjad@riphah.edu.pk
First Name & Middle Initial & Last Name or Official Title & Degree
Muhammad Asif Javed, MS
Phone
923224209422
Email
a.javed@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rida Khawar Dar, MS*
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riphah International University
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Imran Amjad, PhD
Phone
9233224390125
Email
imran.amjad@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
Muhammad Asif Javed, MS
Phone
923224209422
Email
a.javed@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
Rida Khawar Dar, MS*
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35272439
Citation
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.
Results Reference
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Effect Of Pilates On Postural Control And Balance In Children With Down's Syndrome
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