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Weight Bearing Exercises With and Without Jaffrey's Core Stability Exercise Training in Children With Down Syndrome.

Primary Purpose

Down Syndrome

Status
Not yet recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Weight bearing exercises
Jaffrey's core stability exercises
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Down Syndrome

Eligibility Criteria

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

Inclusion Criteria: Children with medical diagnosis of DS Age ranging from 4 to 10 year Both male and female genders Children who was able to stand and walk. Exclusion Criteria: Any orthopedic limitation to exercise such as hip, knee, foot or spinal deformity. Children with planned orthopedic surgery in 6 months. Children with significantly impaired cognition. Children with hearing impairment

Sites / Locations

  • Riphah international university

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Weight bearing exercises

Jaffrey's core stability exercises

Arm Description

weight bearing exercises (I.e standing on preferred foot, standing with close eyes, walking forward on a line using normal stride and heel to toe gait, stepping over response speed stick on balance beam).

Jaffrey's core stability exercises (I.e contracting muscles, sitting on Swiss ball, Bridging, Squatting side lying bridge etc).

Outcomes

Primary Outcome Measures

Pediatric baalnce scale
Pediatric balance scale (PBS), is defined as the ability of a child to attain and maintain upright control. The Pediatric Balance Scale is a modified version of the Berg Balance Scale that is used to assess functional balance skills in school-aged children. The scale consists of 14 items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points.
Trunk Control Measurement Scale
Trunk Control Measurement Scale is a clinical tool to measure trunk control in children

Secondary Outcome Measures

Full Information

First Posted
January 31, 2023
Last Updated
February 8, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05719662
Brief Title
Weight Bearing Exercises With and Without Jaffrey's Core Stability Exercise Training in Children With Down Syndrome.
Official Title
Effects of Weight Bearing Exercises With and Without Jaffrey's Core Stability Exercise Training on Dynamic Balance and Trunk Muscles Strength in Children With Down Syndrome.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 10, 2023 (Anticipated)
Primary Completion Date
July 30, 2023 (Anticipated)
Study Completion Date
September 30, 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

5. Study Description

Brief Summary
Down syndrome also known as trisomy 21, is a genetic disorder caused by the presence of all or part of a third copy of chromosome 21. It is usually associated with physical growth delays, mild to moderate intellectual disability, and characteristic facial features. There is no cure for Down syndrome. Education and proper care have been shown to improve quality of life. Some children with Down syndrome are educated in typical school classes, while others require more specialized education. Those with Down syndrome nearly always have physical and intellectual disabilities. They also typically have poor immune function and generally reach developmental milestones at a later age. They have an increased risk of a number of other health problems, including congenital heart defect, epilepsy, leukemia, thyroid diseases, and mental disorders. This study will determine effects of weight bearing exercises with and without Jaffery's core stability exercise training on dynamic balance and trunk muscles strength in children with Down syndrome. Randomized controlled study will be conducted in which data will be collected from children with down syndrome with calculated sample size of 18 which will randomly assigned into group A and group B. Group A would receive weight bearing exercises (I.e. standing on preferred foot, standing with close eyes, walking forward on a line using normal stride and heel to toe gait, stepping over response speed stick on balance beam ).Group B would receive weight bearing exercises along with the jaffrey's core stability exercises (I.e. contracting muscles, sitting on Swiss ball, Bridging, Squatting side lying bridge etc.).Frequency will be 5 sessions per week, of 1 hour and duration is of 5 months. Balance and trunk muscle strength will be pre assessed using pediatric balance scale and trunk control measurement scale respectively. The improvement will be measured with same tools. Data will be analyzed through SPSS 25.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Weight bearing exercises
Arm Type
Experimental
Arm Description
weight bearing exercises (I.e standing on preferred foot, standing with close eyes, walking forward on a line using normal stride and heel to toe gait, stepping over response speed stick on balance beam).
Arm Title
Jaffrey's core stability exercises
Arm Type
Experimental
Arm Description
Jaffrey's core stability exercises (I.e contracting muscles, sitting on Swiss ball, Bridging, Squatting side lying bridge etc).
Intervention Type
Other
Intervention Name(s)
Weight bearing exercises
Intervention Description
Weight bearing exercises
Intervention Type
Other
Intervention Name(s)
Jaffrey's core stability exercises
Intervention Description
Jaffrey's core stability exercises
Primary Outcome Measure Information:
Title
Pediatric baalnce scale
Description
Pediatric balance scale (PBS), is defined as the ability of a child to attain and maintain upright control. The Pediatric Balance Scale is a modified version of the Berg Balance Scale that is used to assess functional balance skills in school-aged children. The scale consists of 14 items that are scored from 0 points (lowest function) to 4 points (highest function) with a maximum score of 56 points.
Time Frame
4 weeks
Title
Trunk Control Measurement Scale
Description
Trunk Control Measurement Scale is a clinical tool to measure trunk control in children
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children with medical diagnosis of DS Age ranging from 4 to 10 year Both male and female genders Children who was able to stand and walk. Exclusion Criteria: Any orthopedic limitation to exercise such as hip, knee, foot or spinal deformity. Children with planned orthopedic surgery in 6 months. Children with significantly impaired cognition. Children with hearing impairment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Imran Amjad, phd
Phone
03324390125
Email
imran.amjad@riphah.edu.pk
First Name & Middle Initial & Last Name or Official Title & Degree
Sara Khan
Phone
03361057332
Email
Sara.khan@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara Khan, MS
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Riphah international university
City
Lahore
State/Province
Punjab
Country
Pakistan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sana Shahzadi, MS

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Weight Bearing Exercises With and Without Jaffrey's Core Stability Exercise Training in Children With Down Syndrome.

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