NCT05465239

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2020

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 15, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 19, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

January 14, 2025

Completed
Last Updated

January 14, 2025

Status Verified

January 1, 2025

Enrollment Period

2.8 years

First QC Date

July 15, 2022

Results QC Date

November 7, 2024

Last Update Submit

January 10, 2025

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (1)

  • Metabolic Cost (Oxygen Consumption)

    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.

    Five minutes

Study Arms (1)

SurePace Powered Walker User

EXPERIMENTAL

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

Interventions

SurePace Powered Walker UserDEVICE

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).

SurePace Powered Walker User

Eligibility Criteria

Age6 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Virginia Motion Analysis and Motor Performance Lab

Charlottesville, Virginia, 22903, United States

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Results Point of Contact

Title
Jason Burkholder
Organization
Barron Associates, Inc.
burkholder@bainet.com
434-973-1215

Study Officials

  • Jason Burkholder, Ph.D.

    Barron Associates, Inc.

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2022

First Posted

July 19, 2022

Study Start

December 1, 2020

Primary Completion

September 30, 2023

Study Completion

September 30, 2023

Last Updated

January 14, 2025

Results First Posted

January 14, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)