Intelligent and Adaptive Control Applied to Powered Walkers

Barron Associates

Status: Completed

Conditions: Cerebral Palsy

Treatments: Device: SurePace Powered Walker User

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT05465239

SurePace1

2R44HD082863-02 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 6 to 75 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 1 patient group

SurePace Powered Walker User

Experimental group

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.

Treatment:

Device: SurePace Powered Walker User