Clinical trial NCT04023045: Assist-Knee: Energy-Harvesting Knee Prosthesis
Official title: Evaluation of an Energy-Harvesting Knee Prosthesis in Transfemoral Prosthesis Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Transfemoral Amputation
Artificial Limbs
Lead sponsor: Orthocare Innovations, LLC
Sponsor class: INDUSTRY
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2019-07-17
Enrollment: 3
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Crossover clinical trial
Primary purpose: DEVICE_FEASIBILITY

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 Assist-Knee to harvest energy and return energy .


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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)

Primary outcomes:
measure: Time to Complete Sit-to-Stand
timeFrame: Collection at baseline
measure: Time to Complete Sit-to-Stand
timeFrame: After acclimation to Assist-Knee (Participants are given at least 10 minutes and no more than 60 minutes to acclimate to each Assist-Knee condition for safety. After acclimating, participants will complete the maneuver to measure this outcome.)
Secondary outcomes:
measure: Timed Up and Go (TUG) Test
timeFrame: Collection at baseline
measure: Timed Up and Go (TUG) Test
timeFrame: After acclimation to Assist-Knee (Participants are given at least 10 minutes and no more than 60 minutes to acclimate to each Assist-Knee condition for safety. After acclimating, participants will complete the maneuver to measure this outcome.)
measure: Time to Complete Stand-to-Sit
timeFrame: Collection at baseline
measure: Time to Complete Stand-to-Sit
timeFrame: After acclimation to Assist-Knee (Participants are given at least 10 minutes and no more than 60 minutes to acclimate to each Assist-Knee condition for safety. After acclimating, participants will complete the maneuver to measure this outcome.)
measure: Percentage of Body Weight on Contralateral Limb at 65 Degrees Knee Flexion
timeFrame: Collection at baseline
measure: Percentage of Body Weight on Contralateral Limb at 65 Degrees Knee Flexion
timeFrame: After acclimation to Assist-Knee (Participants are given at least 10 minutes and no more than 60 minutes to acclimate to each Assist-Knee condition for safety. After acclimating, participants will complete the maneuver to measure this outcome.)
Other outcomes:
Locations:
city: Edmonds
country: United States
facility: Orthocare Innovations, LLC
state: Washington
Study officials:
affiliation: Orthocare Innovations, LLC
name: Sarah Chang, PhD
role: PRINCIPAL_INVESTIGATOR
References: