NCT07756944

Brief 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.. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 25, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 5, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2026

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2026

Completed
22 days until next milestone

First Posted

Study publicly available on registry

August 11, 2026

Completed
Last Updated

August 11, 2026

Status Verified

August 1, 2026

Enrollment Period

3 months

First QC Date

May 5, 2026

Last Update Submit

August 10, 2026

Conditions

Keywords

Down SyndromeBubble Cushion ExercisesPostural ControlBalance Training

Outcome Measures

Primary Outcomes (1)

  • 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.

    pre assessement of balance was done before the intervention and post assessment after 8 weeks of intervention

Secondary Outcomes (1)

  • trunk control measurement scale

    pre assessment of trunk control was done before the intervention and post assessment after 8 weeks

Study Arms (1)

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.

Other: Bubble cushion exercises

Interventions

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.

bubble cushion exercises

Eligibility Criteria

Age6 Years - 9 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children with a of Down Syndrome
  • Aged between 6-9 years
  • Able to stand and walk alone, able to understand simple instructions

You may not qualify if:

  • Visual or auditory problems
  • Major history of disease or surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children Hospital

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (1)

  • 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.

    PMID: 39835157BACKGROUND

MeSH Terms

Conditions

Down Syndrome

Condition Hierarchy (Ancestors)

Intellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesChromosome DisordersGenetic Diseases, Inborn

Study Officials

  • Nimra Tabassam, MS-PPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: . 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2026

First Posted

August 11, 2026

Study Start

March 25, 2026

Primary Completion

July 5, 2026

Study Completion

July 20, 2026

Last Updated

August 11, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations