Home and Community Use of a Suspension Walker in Pre-Walking Infants With Down Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: suspension walker.
- Who it may be relevant to
- Registry conditions: Down Syndrome. Basic parameters: 10 months — 13 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Feasibility of a Novel Overground Stepping Intervention for Pre-Walking Infants With Down Syndrome
Overview
The goal of this clinical trial is to learn if pre-walking infants with Down syndrome can use a suspension walker in their home and community environments. The main questions it aims to answer are: * Is suspension walker intervention feasible for pre-walking infants with Down syndrome? * What are barriers to successfully using suspension walkers in home and community environments? * What are facilitators for successfully using suspension walkers in home and community environments? Participants will: * Use a suspension walker in the home and community for a three-month period (goal 20 minutes/day, 5 days/week) * Meet with a therapist three times in their home to learn how to use the walker * Track how often they use the walker for one week each month * Complete assessments of infants' gross motor skill and ability to use the walker before and after the three-month period * Be interviewed after the three-month period about their experiences using the walker
Interventions
- Behavioral suspension walker
Parents will be provided with a pediatric suspension walker and instructed to use the walker with their infant at least 20 total min/day, 5 days/week. Parents will be instructed in 3 activity types: 1) Adult-propelled stepping consists of the caregiver moving the walker along the floor to prompt the infant to step. 2) Self-propelled walking consists of encouraging the infant to step independently to propel the walker, with intermittent assistance from the caregiver as needed. 3) Play consists of
Primary outcome measures
- participation in instructed dosage [Time frame: first week of each month for three months]
Secondary outcome measures (5)
- usage frequency and duration [Time frame: first week of each month for three months]
- steps per minute [Time frame: first week of each month for three months]
- gross motor function [Time frame: 0 and 3 months]
- stepping ability [Time frame: 0 and 3 months]
- walker propulsion [Time frame: 0 and 3 months]
Eligibility criteria
Inclusion criteria
- Diagnosis of Down syndrome
- 10-13 months of age
- Able to sit independently
- Unable to walk independently
Exclusion criteria
- Medical or orthopedic conditions other than Down syndrome that prevent standing or walking
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07631130 · 26-02380