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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-18

Study Completion Date

2025-06-16

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Down Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

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

Study Groups

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Dual Task Balance exercise group

Experimental: Dual Task Balance exercise group Clinical experimental: For group -A dual task balance exercise at least lasted 30-45 min on average . 15 minutes for dual task exercise and 30 min for routine physical therapy.Patients will receive total of 16 sessions, 2 sessions per week for 8 weeks.

Group Type EXPERIMENTAL

Dual Task Balance Exercise

Intervention Type OTHER

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)

Vestibular Stimulation group

Active Comparator: VS Group Clinical experimental: For group B VS lasted at least 30-45 min on average . 15 minutes for VS and 30 min for routine physical therapy.Patients will receive total of 16 sessions, 2 sessions per week for 8 weeks.

Group Type ACTIVE_COMPARATOR

Vestibular Stimulation

Intervention Type OTHER

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.

Interventions

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Dual 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)

Intervention Type OTHER

Vestibular Stimulation

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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

7 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No