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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05719662
Other study ID # REC/RCR & AHS/22/0748
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date February 10, 2023
Est. completion date September 30, 2023

Study information

Verified date January 2023
Source Riphah International University
Contact Imran Amjad, phd
Phone 03324390125
Email imran.amjad@riphah.edu.pk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 18
Est. completion date September 30, 2023
Est. primary completion date July 30, 2023
Accepts healthy volunteers No
Gender All
Age group 4 Years to 10 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Weight bearing exercises
Weight bearing exercises
Jaffrey's core stability exercises
Jaffrey's core stability exercises

Locations

Country Name City State
Pakistan Riphah international university Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 4 weeks
Primary Trunk Control Measurement Scale Trunk Control Measurement Scale is a clinical tool to measure trunk control in children 4 weeks
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