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Effect of Supramalleolar Orthosis on Postural Control of Children with Down Syndrome

The Immediate Effect of Supramalleolar Orthosis on Postural Control of Children with Down Syndrome

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20241020063436N1
Enrollment
12
Registered
2024-10-22
Start date
2024-12-21
Completion date
Unknown
Last updated
2025-01-08

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

Conditions

Down syndrome. Down syndrome

Interventions

Intervention group: This group will receive the supramalleolar orthosis as an intervention. This orthosis, which is designed to control the alignment and joints of the foot, will be made of polypropyl

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
4 Years to 10 Years

Inclusion criteria

Inclusion criteria: Children with Down syndrome aged 4 to 10 years Ability to follow simple commands Ability to move independently

Exclusion criteria

Exclusion criteria: Presence of developmental disabilities other than Down syndrome, according to the diagnosis of a specialist History of inner ear disorder or unresolved vision disorder History of seizures

Design outcomes

Primary

MeasureTime frame
Acceleration of center of mass collected by the inertial measurement unit (IMU) sensor. Timepoint: Measurement of center of mass acceleration before the intervention (prior to wearing the supramalleolar orthosis) and immediately after the intervention (while wearing the supramalleolar orthosis). Method of measurement: An inertial measurement unit (IMU) sensor including a three-axis accelerometer and gyroscope.;Velocity of center of mass calculated in MATLAB software using the integration of center of mass acceleration. Timepoint: Measurement of center of mass velocity before the intervention (prior to wearing the supramalleolar orthosis) and immediately after the intervention (while wearing the supramalleolar orthosis). Method of measurement: After measuring center of mass acceleration using the inertial measurement unit sensor, the data will be imported into MATLAB software, version R 2021b. After applying appropriate filters to the acceleration data, the data will be integrated using suitable MATLAB function to calculate the center of mass velocity.;Displacement of center of mass calculated in MATLAB software using double integration of center of mass acceleration. Timepoint: Measurement of center of mass displacement before the intervention (prior to wearing the supramalleolar orthosis) and immediately after the intervention (while wearing the supramalleolar orthosis). Method of measurement: After measuring center of mass acceleration using the inertial measurement unit sensor, the data will be imported into MATLAB software, version R 2021b. After applying appropriate filters to the acceleration data, the data will be double integrated using suitable MATLAB function to calculate the center of mass velocity.;Center of mass path length. Timepoint: Measurement of center of mass path length before the intervention (prior to wearing the supramalleolar orthosis) and immediately after the intervention (while wearing the supramalleolar orthosis). Method of measurement: I

Secondary

MeasureTime frame
Balance skills. Timepoint: Measurement of balance skills before the intervention (prior to wearing the supramalleolar orthosis) and immediately after the intervention (while wearing the supramalleolar orthosis). Method of measurement: The balance subset of the Bruininks-Oseretsky Test of Motor Proficiency, which includes 9 activities.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Hadi Rahmani

Iran University of Medical Sciences

hadirahmani12@gmail.com+98 38 3226 1254

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026