Status:
COMPLETED
Assist-Knee: Energy-Harvesting Knee Prosthesis
Lead Sponsor:
Orthocare Innovations, LLC
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Transfemoral Amputation
Artificial Limbs
Eligibility:
All Genders
21-80 years
Phase:
NA
Brief Summary
The purpose of this research is to validate the Assist-Knee design and function by collecting pilot data during the stand-to-sit-to-stand transition in transfemoral prosthesis users when using the Ass...
Eligibility Criteria
Inclusion
- Unilateral transfemoral limb loss
- At least one year post-amputation and currently successfully using a prosthesis
- Uses modular endoskeletal prosthetic components
- Has bilateral normal range of motion
- Ability to perform the following activities:
- Walking ability or ability to take steps over 10 meters
- Upright standing stability
- Stand-to-sit stability (i.e. go from a standing position to a seated position independently)
- Sit-to-stand stability (i.e. rise from a seated position independently)
- Ability to communicate individual perceptions in the English language
- Ability to provide informed consent
Exclusion
- Confounding injury or musculoskeletal problem
- Pregnancy
- Lower limb peripheral neuropathy
- Symptomatic cardiovascular disease or chronic obstructive pulmonary disease
- Not able to read and understand English
- Use of assistive devices for sit-to-stand and stand-to-sit (e.g. canes, walkers)
Key Trial Info
Start Date :
July 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 26 2020
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT04023045
Start Date
July 15 2019
End Date
February 26 2020
Last Update
October 18 2023
Active Locations (1)
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1
Orthocare Innovations, LLC
Edmonds, Washington, United States, 98020