Down Syndrome Chromosome Disorders
Conditions
Interventions
A feasibility randomized controlled trial with two parallel arms and no blinding will be conducted. Eighteen children with Down Syndrome will be randomly allocated in a 1:1 ratio. Children in the expe
Sponsors
Universidade Federal de Minas Gerais
Universidade Federal de Minas Gerais
Eligibility
Age
1 Years to 4 Years
Inclusion criteria
Inclusion criteria: Children with Down Syndrome; aged between 1 and 4 years; independent walking initiated between 6 and 12 months prior to study enrollment; foot length of up to 18 centimeters.
Exclusion criteria
Exclusion criteria: Participants who do not allow the placement of markers on their body; participants who are unable to follow simple verbal commands; participants who present other associated neurological conditions; participants who present other associated musculoskeletal conditions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome of this study is related to the feasibility of conducting a future randomized clinical trial to investigate the effects of biomimetic footwear compared to habitual footwear. To this end, five feasibility measures will be assessed: acceptability, demand, implementation, practicality, and adaptation. These feasibility measures were adapted based on previous feasibility studies. In addition, the definition of these measures considered the five domains proposed in Bowen’s feasibility framework. | — |
Secondary
| Measure | Time frame |
|---|---|
| Postural control in the standing position will be assessed using the AMTI OR6-7 force platform. Postural control will also be evaluated under the following conditions: barefoot, wearing habitual footwear, and wearing the footwear corresponding to the group to which the child was allocated. The order of the assessment conditions will be randomized prior to data collection. For the postural control assessment, participants will be instructed to remain standing statically on the force platform for 30 seconds. Data related to the velocity, area, and amplitude of center of pressure displacement will be extracted for each group before and after the intervention. ;To assess the kinetic and kinematic gait pattern, the Qualisys Oqus 7 three-dimensional motion analysis system, with ten infrared cameras (Qualisys MEDICAL AB, Gothenburg, Sweden), will be used. The children’s gait pattern will be evaluated under the following conditions: barefoot, wearing habitual footwear, and wearing the footwear corresponding to the group to which the child was allocated. The order of the assessment conditions will be randomized prior to data collection. Gait analysis will be conducted over a 3-minute period, with participants instructed to perform the task at a self-selected walking speed. ;Mobility performance will be assessed using the Pediatric Evaluation of Disability Inventory – Computer Adaptive Test (PEDI-CAT). Following the administration of the PEDI-CAT, the normative and continuous scores from the “Mobility” domain will be extracted. ;Caregivers’ satisfaction regarding the use of the footwear, whether biomimetic or habitual, will be assessed using a questionnaire developed with a 5-point Likert scale. The statements included in this questionnaire were developed based on the Orthotics and Prosthetics User’s Survey (OPUS). | — |
Countries
BR
Contacts
Public ContactAlice Campolina
Universidade Federal de Minas Gerais
Outcome results
None listed