Status:
COMPLETED
Development of a Robotic Ankle Assist Device
Lead Sponsor:
BiOMOTUM, Inc.
Collaborating Sponsors:
Northern Arizona University
Gillette Children's Specialty Healthcare
Conditions:
Cerebral Palsy
Eligibility:
All Genders
8-21 years
Phase:
PHASE1
Brief Summary
The overall objectives of this work is to establish feasibility of a robotic ankle assist device (RAAD) to improve mobility in free-living settings and to establish the RAAD as an effective tool to pr...
Eligibility Criteria
Inclusion
- Diagnosis of cerebral palsy. Any sex, race, ethnicity or socioeconomic status. GMFCS level I, II, or II. Ability to walk for at least 6 minutes (assisted or unassisted). Age between 8-18 years. Height/weight/BMI between the 5th - 95th percentile of children with CP.
- Able to understand and follow simple directions. Able to complete 5 heel raises with minimal assistance (balance only). At least 20 degrees of passive ankle plantar flexion range of motion.
Exclusion
- Knee extension or ankle dorsiflexion contractures greater than 15 degrees. Health condition or diagnosis other than CP that would affect safe participation.
- Orthopedic surgery completed in the prior 12-months. Current enrollment in a conflicting research study.
Key Trial Info
Start Date :
November 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2024
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT04516343
Start Date
November 1 2020
End Date
August 31 2024
Last Update
April 4 2025
Active Locations (1)
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1
Northern Arizona University
Flagstaff, Arizona, United States, 86011