Clinical trial NCT06998199: Dual Task Balance Exercises and Vestibular Stimulation for Children With Down Syndrome
Official title: Effects Of Dual Task Balance Exercises Versus Vestibular Stimulation On Balance Control and Gross Motor Coordination In Children With Down Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Down Syndrome
Keywords: Down syndrome
balance control
Vestibular stimulation
Dual Task balance exercise
gross motor coordination
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2025-05-31
Enrollment: 26
Sex: ALL
Minimum age (years): 7
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Randomized clinical trial performed, in which 26 Down Syndrome children with the age of 7 to 14 years will be taken randomly after screening and meeting inclusion criteria.

Children will be divided in two groups. Group 1 will receive Dual task balance exercises and Group 2 will receive Vestibular stimulations. Both groups will receive total of 16 sessions, 2 sessions per week for 8 weeks. Each session lasted 30-45 min on average. Pre values were taken at 1st week and post values will be taken after 8th week of intervention to measure the effects of both therapies.
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: The Pediatric Balance Scale
timeFrame: Baseline, 1st week and 8th week
measure: Timed up and go test
timeFrame: Baseline, 1st week and 8th week
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Rabia Welfare Hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Amina Shafaqut, MS-PPT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Buyukcelik NM, Yigit S, Turhan B. An investigation of the effects of dual-task balance exercises on balance, functional status and dual-task performance in children with Down syndrome. Dev Neurorehabil. 2023 Jul;26(5):320-327. doi: 10.1080/17518423.2023.2233031. Epub 2023 Jul 4.