NCT06591559

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 12 Months – 36 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Down Syndrome

Interventions

Type	Name	Description
DEVICE	Permobil Explorer Mini	The Explorer Mini (Permobil AB, Sweden) is a commercially available, FDA approved powered mobility device intended for young children between 12-36 months of age with mobility limitations (weight limit: 35 lbs; height limit: 39.4 inches). It is lightweight (52 lbs. including battery) and fits in most automobiles (length: 25 inches; width: 19 inches; adjustable height: 29-37 inches). The Explorer Mini runs on a 12-volt battery with a driving range of 3.5 miles and a maximum speed of 1.5 mph, is controlled via a joystick with a 360-degree turning radius, has proportional speed control with 5 speed options, and can be used in a seated or standing position.
DEVICE	Portable Mobility Aid for Children (PUMA)	The Portable Mobility Aid for Children (PUMA; Enliten LLC) is a portable canopy system that utilizes an overhead support rail structure and a counterweight. The rail structure consists of two rigid parallel beams that mount to the canopy structure and one perpendicular mobile beam that allows for freedom of movement in one direction. Freedom of movement in the opposite direction is achieved by a system of pulleys along the movable beam that connects the harness to a counterweight. The counterweight provides a passive vertical force, counteracting gravity. The PUMA provides 2-dimensional mobility support over 81 ft2 (9 ft x 9 ft). The overhead bar is connected at 4 points to a child-worn harness. Children are free to move through many postures including sitting, crawling, standing, and walking.

Timeline

• Start date: 2024-11-01
• Primary completion: 2025-12-01
• Completion: 2025-12-01
• First posted: 2024-09-19
• Last updated: 2024-09-19