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

University of Washington

Status: Not yet enrolling

Conditions: Down Syndrome

Treatments: Device: Permobil Explorer Mini; Device: Portable Mobility Aid for Children (PUMA)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06591559

STUDY00018915

5TL1TR002318-07 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 estimated patients

Sex: All

Ages: 12 to 36 months old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 4 patient groups

No Device

No Intervention group

Description:

Children will play for 30 minutes using no mobility device.

Explorer Mini in a Seated Posture

Active Comparator group

Description:

Children will play for 30 minutes using the Explorer Mini a seated posture.

Treatment:

Device: Permobil Explorer Mini

Explorer Mini in a Standing Posture

Active Comparator group

Description:

Children will play for 30 minutes using the Explorer Mini a standing posture.

Treatment:

Device: Permobil Explorer Mini

Portable Mobility Aid Partial Body Weight Support Harness (PUMA)

Active Comparator group

Description:

Children will play for 30 minutes with partial bodyweight support provided by the PUMA.

Treatment:

Device: Portable Mobility Aid for Children (PUMA)