Down SyndromeNCT07756944
Effects of Bubble Cushion Exercises on Postural Control in Children With Down Syndrome
A study testing Bubble cushion exercises in people with Down Syndrome, run by Riphah International University at 1 site in Pakistan.
Trial summary
Conducted as a quasi-experimental study. It involves 22 children aged 6-9 years, recruited from different special education schools, who will participate in supervised balance and weight-shifting exercises for 30-45 minutes, three times a week, over 8 weeks.. Read more about this study
- Who is it for?
- Ages 6 to 9 years
- Conditions the study is for
- Down Syndrome
- What is being tested?
- Bubble cushion exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 sitePakistan
- Study dates
- 25 Mar 2026to 20 Jul 2026
- 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 6 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children with a of Down Syndrome
- Aged between 6-9 years
- Able to stand and walk alone, able to understand simple instructions
Who cannot join
- Visual or auditory problems
- Major history of disease or surgery
Trial locations and contacts
1 site in 1 country.
About this study
Conducted as a quasi-experimental study. It involves 22 children aged 6-9 years, recruited from different special education schools, who will participate in supervised balance and weight-shifting exercises for 30-45 minutes, three times a week, over 8 weeks.. Exercises will include seated and standing balance tasks, weight shifting, and all performed on the bubble cushion under supervision. Standardized tools, such as the Pediatric Balance Scale and the Trunk Control Measurement Scale, will be used to assess pre- and post intervention outcomes.
Read the detailed description
Children with Down syndrome (DS) often face significant challenges related to motor development, particularly in postural control and balance. Poor postural control can lead to difficulties in performing basic motor functions, such as sitting, standing, walking, and engaging in daily activities, ultimately affecting the child's independence and quality of life. Therefore, early and targeted therapeutic interventions are crucial to improve motor outcomes in this population. This study aims to investigate the effect of bubble cushion exercises on postural control in children with Down syndrome.
The study will be conducted using a pre-test/post-test experimental design involving 22 children aged 6 to 9years with clinically diagnosed Down syndrome and those who can stand walk and follow instructions. Children who had any history of surgery and those who had visual and hearing impairments will be excluded. Participants will engage in structured bubble cushion exercises for 30 -45 minutes, 3 times a week, over 8 weeks. Exercises will include seated and standing balance tasks, weight shifting, and all performed on the bubble cushion under supervision. Standardized tools, such as the Pediatric Balance Scale and the Trunk Control Measurement Scale, will be used to assess pre- and post intervention outcomes. The study suggests that bubble cushion training is an effective, low-cost intervention for enhancing balance and trunk stability in children with Down syndrome.
- Conditions
- Down Syndrome
- Being tested
- Bubble cushion exercises
- Keywords
- Down Syndrome, Bubble Cushion Exercises, Postural Control, Balance Training
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bubble cushion exercisesOther
Bubble cushion exercises are balance training activities performed on an unstable, air-filled cushion in sitting and standing positions. The unstable surface challenges postural control and activates core muscles, helping improve balance, coordination, proprioception, and trunk stability. Exercises include seated balance tasks, pelvic movements, ball activities, static standing, single-leg stance, reaching, and ball passing, all aimed at enhancing overall postural control in children with Down syndrome.
| Study group | Role | What they receive |
|---|---|---|
| bubble cushion exercises | Experimental | Bubble cushion exercises are balance training activities performed in both sitting and standing positions on an unstable, air-filled cushion. The program includes seated tasks such as maintaining balance, pelvic tilts, pelvic shifts, pelvic circles, and ball toss/catch to improve trunk control and coordination. Standing exercises include static standing, single-leg stance, reaching activities, trunk rotation with ball passing, and ball throwing tasks. These exercises are designed to enhance postural control, balance, proprioception, and core stability by challenging the body to maintain stability on an unstable surface. Receives: Other: Bubble cushion exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
peadtric balance scale
The Pediatric Balance Scale (PBS) is a 14-item assessment tool used to measure functional balance in children. It evaluates both static and dynamic balance through everyday tasks, with each item scored from 0 to 4 and a maximum score of 56. Higher scores indicate better balance ability. The PBS is a reliable and valid tool commonly used in children with motor impairments, including Down syndrome.
Measured: pre assessement of balance was done before the intervention and post assessment after 8 weeks of intervention
Secondary outcomes (1)
trunk control measurement scale
The Trunk Control Measurement Scale (TCMS) is a standardized tool used to assess seated trunk control in children. It evaluates static balance, selective movement control, and dynamic reaching. The total score ranges from 0 to 58, with higher scores indicating better trunk control. Each item is scored from 0 to 3 based on performance, and the best of three attempts is recorded. The TCMS is a reliable and valid measure widely used to assess trunk stability and postural control, especially in children with motor impairments.
Measured: pre assessment of trunk control was done before the intervention and post assessment after 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study start25 Mar 2026
- Primary completion5 Jul 2026
- Study completion20 Jul 2026
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- . It includes 22 children aged 6 to 9 years who can stand, walk, and follow instructions. They will take part in supervised exercises on a bubble cushion for 30-45 minutes, three times a week, over 8 weeks. Their balance and trunk control will be assessed before and after the program using standard measurement tools. The study aims to show that bubble cushion exercises are a simple and low-cost way to improve stability and motor function in these children.
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nimra Tabassam, MS-PPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07756944
- Sponsor's protocol ID
- REC/RCR&AHS/25/0736
- Status last verified
- Aug 2026
- First submitted
- 5 May 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Qian G, Perzanowska E, Kozakiewicz M, Ewertowska P, Yu H, Ossowski Z. Immediate effects of Vojta Therapy on gait ability in down syndrome patients: a pilot study. Front Neurol. 2025 Jan 6;15:1511849. doi: 10.3389/fneur.2024.1511849. eCollection 2024.
PubMed 39835157
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Bubble Cushion Exercises on Postural Control in Children With Down Syndrome
- ClinicalTrials.gov ID
- NCT07756944
- Acronym / sponsor ID
- REC/RCR&AHS/25/0736
- Conditions
- Down Syndrome
- Keywords
- Down Syndrome, Bubble Cushion Exercises, Postural Control, Balance Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 25 Mar 2026 (actual)
- Primary completion
- 5 Jul 2026 (actual)
- Study completion
- 20 Jul 2026 (actual)
- First posted
- 11 Aug 2026 (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.
Conducted as a quasi-experimental study. It involves 22 children aged 6-9 years, recruited from different special education schools, who will participate in supervised balance and weight-shifting exercises for 30-45 minutes, three times a week, over 8 weeks.. Exercises will include seated and standing balance tasks, weight shifting, and all performed on the bubble cushion under supervision. Standardized tools, such as the Pediatric Balance Scale and the Trunk Control Measurement Scale, will be used to assess pre- and post intervention outcomes.
Detailed description
Children with Down syndrome (DS) often face significant challenges related to motor development, particularly in postural control and balance. Poor postural control can lead to difficulties in performing basic motor functions, such as sitting, standing, walking, and engaging in daily activities, ultimately affecting the child's independence and quality of life. Therefore, early and targeted therapeutic interventions are crucial to improve motor outcomes in this population. This study aims to investigate the effect of bubble cushion exercises on postural control in children with Down syndrome.
The study will be conducted using a pre-test/post-test experimental design involving 22 children aged 6 to 9years with clinically diagnosed Down syndrome and those who can stand walk and follow instructions. Children who had any history of surgery and those who had visual and hearing impairments will be excluded. Participants will engage in structured bubble cushion exercises for 30 -45 minutes, 3 times a week, over 8 weeks. Exercises will include seated and standing balance tasks, weight shifting, and all performed on the bubble cushion under supervision. Standardized tools, such as the Pediatric Balance Scale and the Trunk Control Measurement Scale, will be used to assess pre- and post intervention outcomes. The study suggests that bubble cushion training is an effective, low-cost intervention for enhancing balance and trunk stability in children with Down syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- . It includes 22 children aged 6 to 9 years who can stand, walk, and follow instructions. They will take part in supervised exercises on a bubble cushion for 30-45 minutes, three times a week, over 8 weeks. Their balance and trunk control will be assessed before and after the program using standard measurement tools. The study aims to show that bubble cushion exercises are a simple and low-cost way to improve stability and motor function in these children.
| Arm | Type | Receives |
|---|---|---|
| bubble cushion exercises | Experimental | Other: Bubble cushion exercisesBubble cushion exercises are balance training activities performed in both sitting and standing positions on an unstable, air-filled cushion. The program includes seated tasks such as maintaining balance, pelvic tilts, pelvic shifts, pelvic circles, and ball toss/catch to improve trunk control and coordination. Standing exercises include static standing, single-leg stance, reaching activities, trunk rotation with ball passing, and ball throwing tasks. These exercises are designed to enhance postural control, balance, proprioception, and core stability by challenging the body to maintain stability on an unstable surface. |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children with a of Down Syndrome
- Aged between 6-9 years
- Able to stand and walk alone, able to understand simple instructions
Key exclusion criteria (2 listed)
- Visual or auditory problems
- Major history of disease or surgery
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 |
|---|---|---|
| Bubble cushion exercisesBubble cushion exercises are balance training activities performed on an unstable, air-filled cushion in sitting and standing positions. The unstable surface challenges postural control and activates core muscles, helping improve balance, coordination, proprioception, and trunk stability. Exercises include seated balance tasks, pelvic movements, ball activities, static standing, single-leg stance, reaching, and ball passing, all aimed at enhancing overall postural control in children with Down syndrome. | Other | bubble cushion exercises |
Primary outcome
peadtric balance scale
Time frame: pre assessement of balance was done before the intervention and post assessment after 8 weeks of intervention
The Pediatric Balance Scale (PBS) is a 14-item assessment tool used to measure functional balance in children. It evaluates both static and dynamic balance through everyday tasks, with each item scored from 0 to 4 and a maximum score of 56. Higher scores indicate better balance ability. The PBS is a reliable and valid tool commonly used in children with motor impairments, including Down syndrome.
1 secondary outcome
trunk control measurement scale
Time frame: pre assessment of trunk control was done before the intervention and post assessment after 8 weeks
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 11 Aug 2026.
- Background: PubMed 39835157Qian G, Perzanowska E, Kozakiewicz M, Ewertowska P, Yu H, Ossowski Z. Immediate effects of Vojta Therapy on gait ability in down syndrome patients: a pilot study. Front Neurol. 2025 Jan 6;15:1511849. doi: 10.3389/fneur.2024.1511849. eCollection 2024.
- 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.
Nimra Tabassam, 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 Bubble cushion exercises 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 3 inclusion and 2 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 11 Aug 2026. 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?
peadtric balance scale (time frame: pre assessement of balance was done before the intervention and post assessment after 8 weeks of intervention). 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 NCT07756944, 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 11 Aug 2026.