N/A
N=48
Intelligent and Adaptive Control Applied to Powered Walkers
Cerebral Palsy
Bottom Line
View on ClinicalTrials.gov: NCT05465239 ↗Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Metabolic Cost (Oxygen Consumption) — 11.0; 12.7; 7.0; 9.4 J/kg — p=< 0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SurePace Powered Walker User (Device)
- Age
- Pediatric, Adult, Older Adult · 6+ yrs
- Sex
- All
- Sponsor
- Barron Associates, Inc.
- Primary completion
- Sep 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Metabolic Cost (Oxygen Consumption) |
11.0; 12.7; 7.0; 9.4 | < 0.001 sig |
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.
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
Data sourced from ClinicalTrials.gov (NCT05465239). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.