Effect Of Pilates On Postural Control And Balance In Children With Down's Syndrome

Sponsor

Riphah International University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05969873

Collaborator

(none)

Enrollment

Location

Arms

4.5

Anticipated Duration (Months)

4.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Down Syndrome	Other: Pilates exercise Other: Balance training	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

22 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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:

Single (Participant)

Masking Description:

Participants will get separate treatment protocols and possible efforts will be put to mask the both groups about their treatment.

Primary Purpose:

Treatment

Official Title:

Effect Of Pilates On Postural Control And Balance In Children With Down's Syndrome

Actual Study Start Date :

Jul 16, 2023

Anticipated Primary Completion Date :

Nov 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Pediatric Balance Scale [12 weeks]
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 [12 weeks]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 12 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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