Intelligent and Adaptive Control Applied to Powered Walkers

Cerebral Palsy Clinical Trial

Official title:

Intelligent and Adaptive Control Applied to Powered Walkers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05465239
• Other study ID #: SurePace1
• Secondary ID: 2R44HD082863-02
• Status: Completed
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: September 30, 2023

Study information

• Verified date: December 2023
• Source: Barron Associates, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

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).

Locations

Country	Name	City	State
United States	University of Virginia Motion Analysis and Motor Performance Lab	Charlottesville	Virginia

Sponsors (4)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metabolic Cost (oxygen consumption)	Oxygen consumption data will be collected with a Oxycon Mobile (VIASYS Healthcare Inc.) portable indirect calorimetry system.	Five minutes