Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
31 participants
INTERVENTIONAL
2020-11-01
2024-08-31
Brief Summary
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The first specific goal is to assess the benefits of repeated gait training with RAAD assistance. Individuals with CP will participate in a 4-week assistance intervention and mobility outcomes will be quantified pre and post intervention.
The second specific goal is to separately assess the benefits of repeated gait training with RAAD resistance. Individuals with CP will participate in a 4-week resistance intervention and mobility outcomes will be quantified pre and post intervention.
Assessed separately, it is hypothesized that both assistance and resistance training will improve mobility outcomes.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Therapist supervised assistance training
Assistance training with the RAAD under therapist supervision.
Robotic Ankle Assist Device (RAAD)
The RAAD (Robotic Ankle Assist Device) is an intelligent, powered ankle device designed to increase independence, mobility, and deliver gait training to children with movement disorders, such as CP
Therapist supervised resistance training
Resistance training with the RAAD under therapist supervision.
Robotic Ankle Assist Device (RAAD)
The RAAD (Robotic Ankle Assist Device) is an intelligent, powered ankle device designed to increase independence, mobility, and deliver gait training to children with movement disorders, such as CP
Interventions
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Robotic Ankle Assist Device (RAAD)
The RAAD (Robotic Ankle Assist Device) is an intelligent, powered ankle device designed to increase independence, mobility, and deliver gait training to children with movement disorders, such as CP
Eligibility Criteria
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Inclusion Criteria
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 Criteria
Orthopedic surgery completed in the prior 12-months. Current enrollment in a conflicting research study.
8 Years
21 Years
ALL
No
Sponsors
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Northern Arizona University
OTHER
Gillette Children's Specialty Healthcare
OTHER
Shirley Ryan AbilityLab
OTHER
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
BiOMOTUM, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Ray Browning, PhD
Role: PRINCIPAL_INVESTIGATOR
BiOMOTUM, Inc.
Locations
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Northern Arizona University
Flagstaff, Arizona, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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