Down SyndromeNCT06998199
Dual Task Balance Exercises and Vestibular Stimulation for Children With Down Syndrome
A study testing Dual Task Balance Exercise and Vestibular Stimulation in people with Down Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 14 years
- Conditions the study is for
- Down Syndrome
- What is being tested?
- Dual Task Balance Exercise and Vestibular Stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 sitePakistan
- Study dates
- 18 Apr 2025to 16 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects Of Dual Task Balance Exercises Versus Vestibular Stimulation On Balance Control and Gross Motor Coordination In Children With Down Syndrome
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.
Read the 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.
- Conditions
- Down Syndrome
- Being tested
- Dual Task Balance Exercise, Vestibular Stimulation
- Keywords
- Down syndrome, balance control, Vestibular stimulation, Dual Task balance exercise, gross motor coordination
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual Task Balance ExerciseOther
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.
- 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),
- 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 StimulationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Dual Task Balance exercise group | Experimental | 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. Receives: Other: Dual Task Balance Exercise |
| Vestibular Stimulation group | Active comparator | 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. Receives: Other: Vestibular Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Pediatric Balance Scale
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)
Measured: Baseline, 1st week and 8th week
Timed up and go test
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.
- 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.
- On the word "Go," begin timing.
- Stop timing after patient sits back down.
- 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
Measured: Baseline, 1st week and 8th week
Körperkoordinationstest für Kinder (KTK)
The 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).
Measured: Baseline, 1st week and 8th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start18 Apr 2025
- Primary completion2 Jun 2025
- Study completion16 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Down SyndromeStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amina Shafaqut, MS-PPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06998199
- Sponsor's protocol ID
- REC/RCR&AHS/24/0748
- Status last verified
- Jul 2025
- First submitted
- 24 Apr 2025
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37403442
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Of Dual Task Balance Exercises Versus Vestibular Stimulation On Balance Control and Gross Motor Coordination In Children With Down Syndrome
- ClinicalTrials.gov ID
- NCT06998199
- Acronym / sponsor ID
- REC/RCR&AHS/24/0748
- Conditions
- Down Syndrome
- Keywords
- Down syndrome, balance control, Vestibular stimulation, Dual Task balance exercise, gross motor coordination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 18 Apr 2025 (actual)
- Primary completion
- 2 Jun 2025 (actual)
- Study completion
- 16 Jun 2025 (actual)
- First posted
- 31 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Dual Task Balance exercise group | Experimental | Other: Dual Task Balance ExerciseExperimental: 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. |
| Vestibular Stimulation group | Active comparator | Other: Vestibular StimulationActive 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. |
Who may qualify
- Ages
- 7 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dual Task Balance ExerciseThe 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) | Other | Dual Task Balance exercise group |
| Vestibular StimulationThe 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. | Other | Vestibular Stimulation group |
Primary outcome
The Pediatric Balance Scale
Time frame: 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
Time frame: 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
Körperkoordinationstest für Kinder (KTK)
Time frame: Baseline, 1st week and 8th week
The 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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
- Background: PubMed 37403442Buyukcelik 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amina Shafaqut, MS-PPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual Task Balance Exercise and Vestibular Stimulation in people with Down Syndrome, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Pediatric Balance Scale (time frame: Baseline, 1st week and 8th week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06998199, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2025.