Intelligent and Adaptive Control Applied to Powered Walkers

Not Applicable

Completed

• Conditions: Cerebral Palsy
• Interventions: Device: SurePace Powered Walker User

• Registration Number: NCT05465239
• Lead Sponsor: Barron Associates, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-01
• Study First Submitted: 2022-07-15
• Study First Submitted QC: 2022-07-15
• Study First Posted: 2022-07-19
• Primary Completion: 2023-09-30
• Study Completion: 2023-09-30
• Results First Submitted: 2024-11-07
• Status Verified: 2025-01
• Results First Submitted QC: 2025-01-10
• Last Update Submitted: 2025-01-10
• Results First Posted: 2025-01-14
• Last Update Posted: 2025-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SurePace Powered Walker User	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.

Primary Outcome Measures

Name	Time	Method
Metabolic Cost (Oxygen Consumption)	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.

Trial Locations

Locations (1)

University of Virginia Motion Analysis and Motor Performance Lab; 🇺🇸 Charlottesville, Virginia, United States