Up, Down, and All Around: Evaluating Mobility Devices for Young Children with Down Syndrome

Not Applicable

Not yet recruiting

• Conditions: Down Syndrome
• Interventions: Device: Permobil Explorer Mini; Device: Portable Mobility Aid for Children (PUMA)

• Registration Number: NCT06591559
• Lead Sponsor: University of Washington

Brief Summary

This research study will examine young children with Down syndrome's initial experiences with mobility devices. Children's biomechanics and exploration will be quantified while they are using both an overground partial bodyweight support system and powered mobility device.

Detailed Description

Young children with Down syndrome experience delays in cognition, communication, and mobility. As a result of cerebellar hypoplasia, children with Down syndrome have altered balance and coordination, muscle hypotonia, decreased muscle strength, and ligament laxity. Low muscle tone and ligament laxity can lead to the adoption of unfavorable postures, putting children at risk for developing musculoskeletal disorders in the future.

While children with Down syndrome are expected to walk, they do so significantly later than their peers, creating a gap in mobility, exploration, and socialization in the first years of life. Mobility during the first years is crucial to facilitate cascades of reciprocal development in cognition, communication, and motor skills, as well as reduce developmental delays and participation disparities for children with Down syndrome compared to their peers. While early intervention is common during this time to facilitate movement, clinical practice patterns vary widely and there are few evidence-based interventions or assistive technologies to support children and their families.

Treadmill training is currently the only intervention that has demonstrated efficacy for young children with hypotonia, but only for improving walking speed among already ambulatory children. Traditional treadmill training is limited, however, in that it does not allow for the sensorimotor experiences and social interactions that occur with self-initiated mobility in enriched, and often unpredictable, natural environments. As such, treadmill training and other clinical interventions may not fully address the need for holistic and multi-modal mobility opportunities.

Augmented mobility - in the form of partial bodyweight support systems, gait trainers, and powered mobility - has been proposed as a promising and complementary intervention to support early development in Down syndrome. While these tools have the potential to bridge the gap in self-initiated mobility and accelerate the onset of independent walking, little is scientifically known about how children engage with these devices nor how these devices shape their interactions with their environment. Furthermore, there is a lack of knowledge concerning the impact of different mobility devices on a child's physical development and posture.

In this research, the investigators propose to quantify a child's exploration, posture, and motor control strategies while using two promising assistive technologies for pre-ambulatory young children with Down syndrome: a partial-bodyweight support system (PUMA, Enliten, LLC.) and a powered mobility device (Explorer Mini, Permobil) that can be used in both seated and standing postures.

Participants will attend a total of four play sessions where they will play with a) no devices, b) partial bodyweight support, c) in the Explorer Mini in a standing posture, and d) in the Explorer Mini in a seated posture.

Basic Information
|
Recruitment & Eligibility
|
Study & Design

Study Timeline

• Study First Submitted: 2024-06-12
• Status Verified: 2024-09
• Study First Submitted QC: 2024-09-06
• Study First Posted: 2024-09-11
• Last Update Submitted: 2024-09-13
• Last Update Posted: 2024-09-19
• Study Start: 2024-11
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• have a diagnosis of Down syndrome
• are between 12-36 months of age
• are able to sit upright without support
• are able to tolerate moving through space while upright for 30 minutes
• are under 35 pounds in weight
• are under 39 inches tall in height

Read More

Exclusion Criteria

• are able to walk 10 ft independently
• have had previous experience with the Explorer Mini or PUMA systems

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Explorer Mini in a Seated Posture	Permobil Explorer Mini	Children will play for 30 minutes using the Explorer Mini a seated posture.
Explorer Mini in a Standing Posture	Permobil Explorer Mini	Children will play for 30 minutes using the Explorer Mini a standing posture.
Portable Mobility Aid Partial Body Weight Support Harness (PUMA)	Portable Mobility Aid for Children (PUMA)	Children will play for 30 minutes with partial bodyweight support provided by the PUMA.

Primary Outcome Measures

Name	Time	Method
Percentage of space explored	At the end of each 30-minute play session for each study arm (session 1, session 2, session 3, session 4)	The path of each child's movement during the play sessions will be tracked from video recordings and sensor data. The path will then be used to determine the percentage of the available play space that the child explored. Values will range from 0 - 100%, a higher value indicates more space explored.

Secondary Outcome Measures

Name	Time	Method
Normalized Integrated Electromyography (EMG)	At the end of each 30-minute play session for each study arm (session 1, session 2, session 3, session 4)	Children will wear electromyography (EMG) sensors while playing. We will measure the bilateral muscle activity of the tibialis anterior, gastrocnemius, quadriceps, hamstrings (biceps femoris), erector spinae, and cervical paraspinal using surface EMGs. EMG data will be high-pass filtered (40 Hz), rectified, and low-pass filtered (10 Hz) to create a linear envelope of muscle activity during play sessions. For each muscle group, we will calculate the integrated EMG signal, or area under the curve, for each session normalized by time in device. Values will range from 0 to 100%, higher values indicate more muscle activity.
Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST) 2.1: Children Version	At the end of each 30-minute play session for each study arm (session 1, session 2, session 3, session 4)	The QUEST 2.1: Children Version is an extension of the original QUEST tool tailored specifically for children who use assistive technology. The primary aim of this test is to evaluate how well assistive technology devices meet the needs of children and enhance their overall satisfaction with these devices. The questionnaire is designed to gather information on various aspects of the assistive technology, including its functionality, ease of use, and impact on the life of the user.