- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05719662
Weight Bearing Exercises With and Without Jaffrey's Core Stability Exercise Training in Children With Down Syndrome.
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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sara Khan
- Phone Number: 03361057332
- Email: Sara.khan@riphah.edu.pk
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan
- Riphah International University
-
Principal Investigator:
- Sana Shahzadi, MS
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Weight bearing exercises
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).
|
Weight bearing exercises
|
|
EXPERIMENTAL: Jaffrey's core stability exercises
Jaffrey's core stability exercises (I.e contracting muscles, sitting on Swiss ball, Bridging, Squatting side lying bridge etc).
|
Jaffrey's core stability exercises
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pediatric baalnce scale
Time Frame: 4 weeks
|
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.
|
4 weeks
|
|
Trunk Control Measurement Scale
Time Frame: 4 weeks
|
Trunk Control Measurement Scale is a clinical tool to measure trunk control in children
|
4 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sara khan, MS, Riphah International University
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR & AHS/22/0748
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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