NCT05719662

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 9, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

February 10, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

February 9, 2023

Status Verified

January 1, 2023

Enrollment Period

6 months

First QC Date

January 31, 2023

Last Update Submit

February 8, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • Trunk Control Measurement Scale

    Trunk Control Measurement Scale is a clinical tool to measure trunk control in children

    4 weeks

Study Arms (2)

Weight bearing exercises

EXPERIMENTAL

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).

Other: Weight bearing exercises

Jaffrey's core stability exercises

EXPERIMENTAL

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

Other: Jaffrey's core stability exercises

Interventions

Weight bearing exercises

Weight bearing exercises

Jaffrey's core stability exercises

Jaffrey's core stability exercises

Eligibility Criteria

Age4 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah international university

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Down Syndrome

Condition Hierarchy (Ancestors)

Intellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, Inborn

Study Officials

  • Sara Khan, MS

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2023

First Posted

February 9, 2023

Study Start

February 10, 2023

Primary Completion

July 30, 2023

Study Completion

September 30, 2023

Last Updated

February 9, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations