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

Effects Of Dual Task Balance Exercises Versus Vestibular Stimulation On Balance Control and Gross Motor Coordination In Children With Down Syndrome

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06998199
Enrollment
26
Registered
2025-05-31
Start date
2025-04-18
Completion date
2025-06-16
Last updated
2025-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Down Syndrome

Keywords

Down syndrome, balance control, Vestibular stimulation, Dual Task balance exercise, gross motor coordination

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.

Interventions

OTHERDual Task Balance Exercise

The content of the DT training is summarized below with 30 minutes of routine PT. Participants will receive total of 16 sessions, 2 sessions per week for 8 weeks. 1. Walking 3 m on hard/soft ground while performing a motor task (carrying an empty box) and then combined with a cognitive task (saying the names of some fruits and vegetables), 2. Sitting on a Pilates ball for 1 min with eyes open/closed while performing a motor task (arms flexed to 90 degrees) and then combined with a cognitive task (saying the names of friends) 3)2-feet Jumping forward with both feet for 3 m while performing a motor task (carrying an empty box) then with a cognitive task (naming the colors in the room) 4)Standing on one leg for 30 s while arms abducted to 90 degrees and then combined with a cognitive task (saying the names of relatives) 5)Sit-to-stand using a stool 15 repetitions with a motor task (carrying an empty box) and then with a cognitive task (saying the names vegetables etc)

The child will place in sitting position on the swing and his hands grasping the ropes at the sides then the therapist stand behind him and begin pushing the platform in fast and jerky movement in back and front, side to side and in spinning directions with the child trying to maintain his balance in all different directions. The subject will receive pushing for each direction for five minutes; the total mechanical vestibular session duration was 15 minutes with 30 minutes of routine physical therapy. Participants will receive total of 16 sessions, 2 sessions per week for 8 weeks.

Sponsors

Riphah International University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Masking description

Participants will get separate treatment protocols and possible efforts will be put to mask the both group about the treatment

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.

Eligibility

Sex/Gender
ALL
Age
7 Years to 14 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The Pediatric Balance ScaleBaseline, 1st week and 8th weekThe 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 testBaseline, 1st week and 8th weekThe '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
Körperkoordinationstest für Kinder (KTK)Baseline, 1st week and 8th weekThe Körperkoordinationstest für Kinder (KTK), also known as the Body Coordination Test for Children to measure gross motor coordination in children aged 5 to 15 years. The KTK consists of four subtests: walking backward on balance beams of varying widths, jumping sideways with both feet together, moving sideways on boxes, and hopping for height on one leg which takes 15 minutes per child. The results from the four tasks are used to calculate a Motor Quotient (MQ). A score below an MQ of 85 is typically considered indicative of motor difficulties. KTK showed acceptable construct validity, indeed, the test-retest for the raw score on the test protocol detected a reliability coefficient of 0.97, and for each item, reliability coefficients ranged from (0.80 to 0.96).

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026