Evaluation of an Energy-Harvesting Knee Prosthesis in Transfemoral Prosthesis Users
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Transfemoral Amputation
- Sponsor
- Orthocare Innovations, LLC
- Enrollment
- 3
- Locations
- 1
- Primary Endpoint
- Time to Complete Sit-to-Stand
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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 .
Investigators
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
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)
Outcomes
Primary Outcomes
Time to Complete Sit-to-Stand
Time Frame: 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.)
The amount of time, measured in seconds, needed by the subject to complete the sit-to-stand transition. At least four trials of the sit-to-stand maneuver were collected for each participant using a motion analysis system. Average and standard deviation of the time to complete the sit-to-stand transition were calculated for each participant (each participant served as their own control in this pilot study). The start of the transition was determined by participant initiation; the end of the transition was determined by the participant reaching full knee extension.
Secondary Outcomes
- Timed Up and Go (TUG) Test(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.))
- Percentage of Body Weight on Contralateral Limb at 65 Degrees Knee Flexion(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.))
- Time to Complete Stand-to-Sit(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.))