Dual Task Balance Exercises and Vestibular Stimulation for Children With Down Syndrome

Not Applicable

Recruiting

• Conditions: Down Syndrome

• Registration Number: NCT06998199
• Lead Sponsor: Riphah International University

Brief Summary

Children with Down syndrome experience balance and postural control issues due to neuromuscular defects and face several impairments. For the improvement we will take 26 children with Down syndrome, age between 7 to 14 years will be randomly assign into two groups.

Group A will perform Dual Task Balance exercises and group B will perform Vestibular Stimulation exercises along routine physical therapy.All the data will be collected from Rabia Welfare Hospital Lahore by using Pediatric Balance Scale, Time Up and Go test and KTK test.The duration of study will be 10 months. Data will be analyzed through SPSS version 25.00.

Detailed Description

Down syndrome is a genetic disorder experience balance issues due to neuromuscular defects which present with several impairments such as hypotonic, ligament laxity, decreased muscle strength, insufficient muscular co-contraction, inadequate postural control, intellectual disabilities, sensory integration difficulties and disturbed proprioception. The current study will be randomized clinical trial, data will be collected from Rabia Welfare Hospital Lahore. The study will include 26 patients equally divided into two groups and randomly allocated. Inclusion criteria for the study will include patients diagnosed with Down syndrome, age between 7 to 14 years(both genders), able to understand instructions and command necessary for intervention and children which able to stand momently but with history of frequent falling during walking. Patients with Atlanto axial instability, Cardiopulmonary, Orthopedic and Neurological problems, cognitive impairment that interferes with communication, BMI of ≥30 kg/m2 and children which actively participating in sports will be excluded.Group A will perform Dual Task Balance exercises and group B will perform Vestibular Stimulation exercises along routine physical therapy.Both groups will receive total of 16 sessions, 2 sessions per week for 8 weeks. Each session lasted 30-45 min on average.Then evaluate both groups on follow up.Before and after intervention period, balance and gross motor coordination will be assessed by Pediatric Balance Scale, Time Up and Go test and KTK test. The reliability and validity of tools mentioned. Data collection will be done before and after the intervention. Data will be analyzed through SPSS version 25.00.

Study Timeline

• Study Start: 2025-04-18
• Study First Submitted: 2025-04-24
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-27
• Last Update Submitted: 2025-05-27
• Study First Posted: 2025-05-31
• Last Update Posted: 2025-05-31
• Primary Completion: 2025-06-02
• Study Completion: 2025-06-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• Patients diagnosed with Down syndrome.
• Age between 7 to 14 years.
• Both the genders were included.
• Able to talk and comprehend instructions & command.
• Children which able to stand momently but with history of frequent falling during walking

Exclusion Criteria

• Child with Atlanto axial instability.
• Uncontrolled cardiopulmonary problems.
• Body mass index (BMI) of ≥30 kg/m2.
• Children with orthopedic problems and affecting gait.
• Cognitive impairment that interferes with communication.
• Neurological problems.
• Children which actively participating in sports

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The Pediatric Balance Scale	Baseline, 1st week and 8th week	The Pediatric Balance Scale (PBS), a modified version of Berg's Balance Scale, was designed to assess balance in school-aged children with mild to severe motor deficits. 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. Reliability testing performed with a sample of 20 children ages 5-15 years old with mild to moderate motor impairments showed good test-retest reliability (ICC=0.998) and good inter rater reliability (ICC=0.997)
Timed up and go test	Baseline, 1st week and 8th week	The 'timed up and go' test (TUG) is a simple, quick and widely used clinical performance based measure of lower extremity function, mobility and fall risk.; 1. Begin by having the patient sit back in a standard arm chair and identify a line 3 meters, or 10 feet away, on the floor.; 2. On the word "Go," begin timing.; 3. Stop timing after patient sits back down.; 4. Record the time. The TUG has demonstrated good test-retest reliability (ICC 0.80-0.99), validity, and sensitivity to change. It has a moderate correlation with fall risk

Trial Locations

Locations (1)

Rabia Welfare Hospital; 🇵🇰 Lahore, Punjab, Pakistan