MedTrace Logo

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

NCT06591559 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2026-05-04

No results posted yet for this study

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
  • Gross Motor Delay
  • Cerebral Palsy

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Heather A Feldner, PhD, PT, PCS · University of Washington

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
12 Months
Max Age
60 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-11
Primary Completion
2026-03-30
Completion
2026-03-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06591559 on ClinicalTrials.gov