Up, Down, and All Around: Evaluating Mobility Devices for Young Children With Developmental Disabilities and Delays

NCT06591559 | Completed FDA Device

• 2 other identifiers: STUDY000189155TL1TR002318-07
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Down Syndrome; Cerebral Palsy; Gross Motor Delay

Keywords

early intervention; mobility aid; powered mobility; partial bodyweight support

Outcome Measures

Primary Outcomes (1)

• Percentage of space explored

  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.

  At the end of each 30-minute play session for each study arm (session 1, session 2, session 3, session 4)

Secondary Outcomes (2)

• 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)

• 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)

Study Arms (4)

No Device

NO INTERVENTION

Children will play for 30 minutes using no mobility device.

Explorer Mini in a Seated Posture

ACTIVE COMPARATOR

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

Device: Permobil Explorer Mini

Explorer Mini in a Standing Posture

ACTIVE COMPARATOR

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

Device: Permobil Explorer Mini

Portable Mobility Aid Partial Body Weight Support Harness (PUMA)

ACTIVE COMPARATOR

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

Device: Portable Mobility Aid for Children (PUMA)

Interventions

Permobil Explorer Mini DEVICE

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.

Explorer Mini in a Seated Posture; Explorer Mini in a Standing Posture

Portable Mobility Aid for Children (PUMA) DEVICE

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.

Portable Mobility Aid Partial Body Weight Support Harness (PUMA)

Eligibility Criteria

• Age: 12 Months - 60 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• are able to sit upright independently
• 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
• developmental delays and conditions that affect mobility and muscle tone

You may not qualify if:

• \- are able to walk 10 ft independently

Sponsors & Collaborators

• University of Washington: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Down Syndrome; Cerebral Palsy

Condition Hierarchy (Ancestors)

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases

Study Officials

• Heather A Feldner, PhD, PT, PCS

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, School of Medicine

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: September 19, 2024
• Study Start: February 11, 2025
• Primary Completion: March 30, 2026
• Study Completion: March 30, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)