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Intelligent and Adaptive Control Applied to Powered Walkers

Primary Purpose

Cerebral Palsy

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SurePace Powered Walker User
Sponsored by
Barron Associates, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cerebral Palsy

Eligibility Criteria

6 Years - 75 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Virginia Motion Analysis and Motor Performance LabRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SurePace Powered Walker User

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 15, 2022
Last Updated
August 29, 2023
Sponsor
Barron Associates, Inc.
Collaborators
University of Virginia, National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT05465239
Brief Title
Intelligent and Adaptive Control Applied to Powered Walkers
Official Title
Intelligent and Adaptive Control Applied to Powered Walkers
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Barron Associates, Inc.
Collaborators
University of Virginia, National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SurePace Powered Walker User
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
SurePace Powered Walker User
Intervention Description
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 Outcome Measure Information:
Title
Metabolic Cost (oxygen consumption)
Description
Oxygen consumption data will be collected with a Oxycon Mobile (VIASYS Healthcare Inc.) portable indirect calorimetry system.
Time Frame
Five minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shawn Russell, Ph.D.
Phone
434 243 6847
Email
sdr2n@virginia.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Burkholder, Ph.D.
Organizational Affiliation
Barron Associates, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia Motion Analysis and Motor Performance Lab
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shawn Russell, Ph.D.
Phone
434-243-6847
Email
sdr2n@virginia.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Intelligent and Adaptive Control Applied to Powered Walkers

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