PlayGait is an investigational dynamic energy storage and return (ESR) lower-limb exoskeleton for young children with cerebral palsy (CP), that stores energy while the child is in the stance phase of walking and returns that energy in terminal stance and early swing phase of walking. PlayGait assists with the passive dynamics of walking through an exotendon (comprised of a spring in series with a cable). The overall objective of this investigational device is to promote correct walking patterns that encourage proper bone alignment, muscle recruitment, and strengthening during walking practice in young children with CP. The study will evaluate children with CP's activity levels in the community with and without PlayGait. The study will consist of three lab visits and two, 7-day periods at home.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
1
PlayGait is a dynamic energy storing and returning lower-limb exoskeleton.
Baseline condition with no prescribed or intervention lower-limb devices.
Orthocare Innovations, LLC
Edmonds, Washington, United States
Cadence
Low, medium, and high activity rate
Time frame: 7 days with baseline condition; 7 days with PlayGait condition
Shifts in cadence
Shifts from low to medium cadence and shifts from medium to high cadence
Time frame: 7 days with baseline condition; 7 days with PlayGait condition
1 minute walk test
The distance walked in one minute
Time frame: 1st lab session (baseline); 3rd lab session with PlayGait after 7 days of wearing PlayGait
10 meter walk test
The time it takes to walk 10 meters
Time frame: 1st lab session (baseline); 3rd lab session with PlayGait after 7 days of wearing PlayGait
Pediatric Balance Scale
Participant completes 14 activity items that measure pediatric balance
Time frame: 1st lab session (baseline); 3rd lab session with PlayGait after 7 days of wearing PlayGait
Average steps per day
Step count per day
Time frame: Baseline Condition: 7 days in the community without PlayGait (no lower-limb assistive devices); PlayGait condition: 7 days with PlayGait
Time of PlayGait use
Amount of time each day that PlayGait is worn
Time frame: PlayGait condition: 7 days in the community with PlayGait
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.