Cerebral Palsy
Conditions
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.
Interventions
DEVICESurePace 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).
Sponsors
University of Virginia
National Institutes of Health (NIH)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Barron Associates, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited based on physician referral at the University of Virginia medical center. The first participant was enrolled in December 2020 and the last participant was enrolled in September 2023.
Pre-assignment details
48 enrolled participants met the inclusion criteria and completed the study.
Participants by arm
| Arm | Count |
|---|---|
| Control Subjects Normally developed subjects without walking disabilities. | 24 |
| Walking Disability Subjects Subjects with walking disabilities, such as cerebral palsy. | 24 |
| Total | 48 |
Baseline characteristics
| Characteristic | Control Subjects | Total | Walking Disability Subjects |
|---|---|---|---|
| Age, Continuous | 16.1 years STANDARD_DEVIATION 17.2 | 15.8 years STANDARD_DEVIATION 18.1 | 15.5 years STANDARD_DEVIATION 5.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 4 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants | 44 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 21 Participants | 38 Participants | 17 Participants |
| Region of Enrollment United States | 24 participants | 48 participants | 24 participants |
| Sex: Female, Male Female | 15 Participants | 24 Participants | 9 Participants |
| Sex: Female, Male Male | 9 Participants | 24 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 24 | 0 / 24 | 0 / 24 |
| other Total, other adverse events | 0 / 24 | 0 / 24 | 0 / 24 | 0 / 24 |
| serious Total, serious adverse events | 0 / 24 | 0 / 24 | 0 / 24 | 0 / 24 |
Outcome results
Primary
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.
Time frame: Five minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Subjects: Unpowered Walker | Metabolic Cost (Oxygen Consumption) | 11.0 J/kg | Standard Deviation 2.9 |
| Walking Disability Subjects: Unpowered Walker | Metabolic Cost (Oxygen Consumption) | 12.7 J/kg | Standard Deviation 3.3 |
| Control Subjects: Powered Walker | Metabolic Cost (Oxygen Consumption) | 7.0 J/kg | Standard Deviation 1.2 |
| Walking Disability Subjects: Powered Walker | Metabolic Cost (Oxygen Consumption) | 9.4 J/kg | Standard Deviation 3.5 |
p-value: <0.001t-test, 1 sided
p-value: <0.001t-test, 1 sided