Intelligent and Adaptive Control Applied to Powered Walkers

Sponsor
Barron Associates, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05465239
Collaborator
University of Virginia (Other), National Institutes of Health (NIH) (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)
60
1
1
36.9
1.6

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: SurePace Powered Walker User
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Intelligent and Adaptive Control Applied to Powered Walkers
Actual Study Start Date :
Sep 1, 2020
Anticipated Primary Completion Date :
Sep 30, 2023
Anticipated Study Completion Date :
Sep 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: SurePace Powered Walker User

Before any formal experiments are conducted, participants will be given an opportunity to "train" with the new powered walker for a pre-defined period of time to eliminate the confounding effects of being unfamiliar with using the device. (See the description of UVA's facilities and Protection of Human Subjects document for additional discussion of safety measures/protocols and Institutional Review Board procedures.) Experiments will consist of one-hour sessions (with adequate rest periods between trials and time for evaluations) in which participants will be asked to walk at a self-selected (comfortable) walking speed through a pre-defined 8 m x 4 m oval course.

Device: SurePace Powered Walker User
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).

Outcome Measures

Primary Outcome Measures

  1. Metabolic Cost (oxygen consumption) [Five minutes]

    Oxygen consumption data will be collected with a Oxycon Mobile (VIASYS Healthcare Inc.) portable indirect calorimetry system.

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Virginia Motion Analysis and Motor Performance Lab Charlottesville Virginia United States 22903

Sponsors and Collaborators

  • Barron Associates, Inc.
  • University of Virginia
  • National Institutes of Health (NIH)
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

  • Principal Investigator: Jason Burkholder, Ph.D., Barron Associates, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Barron Associates, Inc.
ClinicalTrials.gov Identifier:
NCT05465239
Other Study ID Numbers:
  • SurePace1
  • 2R44HD082863-02
First Posted:
Jul 19, 2022
Last Update Posted:
Jul 27, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 27, 2022