Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
36 participants
INTERVENTIONAL
2024-03-01
2027-12-31
Brief Summary
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Participants will:
* Wear a sensor that records everyday activities and mobility.
* Perform measures of mobility and different activities of participation using their own brace.
* Perform measures of mobility and different activities of participation using the Nomad powered KAFO
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Group A
Group A receives the intervention Nomad KAFO first; fitting \& training will occur with the intervention and will then be used for a 3 month home trial, followed by outcomes testing. Group A then will cross over and train with their own Traditional Assistive Device and will then use their own device for a 3 month home trial, followed by outcomes testing.
Indego Nomad® Powered Knee-Ankle-Foot Orthosis (P-KAFO) (Parker Hannifin Corp., Cleveland, OH)
The Nomad is a microprocessor-controlled knee-ankle-foot orthosis P-KAFO that incorporates a motor for powered movement assistance and an electronic brake for stance support. The system provides active assistance for knee flexion and extension during the swing phase of gait, reliable stance phase locking at any knee angle, and reliable unlocking without requiring user-generated knee or hip extension torque.
Group B
Group B receives training in their own Traditional Assistive Device first; training will occur with their own Traditional Assistive Device and will then use their own device for a 3 month home trial, followed by outcomes testing. Group B then will cross over and receive the intervention Nomad KAFO; fitting \& training will occur with the intervention and will then be used for a 3 month home trial, followed by outcomes testing.
Indego Nomad® Powered Knee-Ankle-Foot Orthosis (P-KAFO) (Parker Hannifin Corp., Cleveland, OH)
The Nomad is a microprocessor-controlled knee-ankle-foot orthosis P-KAFO that incorporates a motor for powered movement assistance and an electronic brake for stance support. The system provides active assistance for knee flexion and extension during the swing phase of gait, reliable stance phase locking at any knee angle, and reliable unlocking without requiring user-generated knee or hip extension torque.
Interventions
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Indego Nomad® Powered Knee-Ankle-Foot Orthosis (P-KAFO) (Parker Hannifin Corp., Cleveland, OH)
The Nomad is a microprocessor-controlled knee-ankle-foot orthosis P-KAFO that incorporates a motor for powered movement assistance and an electronic brake for stance support. The system provides active assistance for knee flexion and extension during the swing phase of gait, reliable stance phase locking at any knee angle, and reliable unlocking without requiring user-generated knee or hip extension torque.
Eligibility Criteria
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Inclusion Criteria
* Cognitive ability to understand and follow the study protocol; willingness to provide informed consent
* Willing to wear and charge an activity monitor for three-months home trials.
Exclusion Criteria
* Non-correctable knee varus/valgus in excess of 15 degrees
* Severe spasticity
* Inability to stabilize the trunk with or without assistive devices (crutches, canes, etc.)
18 Years
89 Years
ALL
No
Sponsors
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Shirley Ryan AbilityLab
OTHER
Responsible Party
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Arun Jayaraman, PT, PhD
Principal Investigator
Locations
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Shirley Ryan AbilityLab
Chicago, Illinois, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STU00217395
Identifier Type: -
Identifier Source: org_study_id
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