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OpenTrials
Completed

NCT Number: NCT05465239

Intelligent and Adaptive Control Applied to Powered Walkers

The research is towards an advanced control and computer learning strategy that will intelligently drive a powered walker for people with walking disabilities. The aim of the control strategy is to provide powered assistance that optimally reduces the metabolic cost of walking. The goal of the proposed intelligent walker is to reduce the workload of walking, keeping this population walking longer, providing critical exercise, continued muscle development and improved quality of life.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

6 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Virginia Motion Analysis and Motor Performance Lab

Charlottesville, Virginia, 22903, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Typically developed subjects:

  • No walking disabilities

Subjects with CP:

  • Diagnosed with spastic CP
  • GMFCS level II-III
  • Ages 5-25 inclusive
  • No surgeries in last 6 months
  • Able to ambulate 40ft unaided (excluding walker)
  • Understand and follow commands

Exclusion criteria

Typically developed subjects:

  • Observed intramuscular pathology

Subjects with CP:

  • Mental retardation
  • Severe uncontrolled seizures
  • Leg or foot surgery in last 12 months
  • Surgery or significant injury in last 6 months affecting
  • walking ability
  • Inability to ambulate unassisted (other than walker) 40ft
  • without stopping to rest
  • Inability to understand or follow commands

Treatment and study plan

SurePace Powered Walker User

Device

Participants will be asked to perform one baseline 5-minute trial with the lab's instrumented walker in passive mode (no powered locomotion) and two 5-minute trials with the walker in active mode (powered locomotion).

Primary outcomes

  1. Metabolic Cost (Oxygen Consumption)

    Time frame: Five minutes

    Oxygen consumption data will be collected with a Oxycon Mobile (VIASYS Healthcare Inc.) portable indirect calorimetry system. The outcome measure is the reduction in metabolic cost of using the powered walker compared to an unpowered walker.

Sponsors and collaborators

Lead sponsor

Barron Associates, Inc.

Industry

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Institutes of Health (NIH)
  • University of Virginia

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jul 19, 2022
Registry last updated
Jan 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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