Assist-Knee: Energy-Harvesting Knee Prosthesis

Transfemoral Amputation Clinical Trial

Official title:

Evaluation of an Energy-Harvesting Knee Prosthesis in Transfemoral Prosthesis Users

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04023045
• Other study ID #: 7826-01
• Secondary ID: 1R43HD097826
• Status: Completed
• Phase: N/A
• Start date: July 15, 2019
• Est. completion date: February 26, 2020

Study information

• Verified date: October 2023
• Source: Orthocare Innovations, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: February 26, 2020
• Est. primary completion date: February 26, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Artificial Limbs
• Transfemoral Amputation

Intervention

Device:
• Assist-Knee
Assist-Knee is an experimental lower limb knee prosthesis.
• Habitual Prosthesis
Habitual baseline prosthesis prescribed by participant's clinician.

Locations

Country	Name	City	State
United States	Orthocare Innovations, LLC	Edmonds	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Orthocare Innovations, LLC	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Complete Sit-to-Stand	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.	Collection at baseline
Primary	Time to Complete Sit-to-Stand	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.	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	Timed Up and Go (TUG) Test	The Timed Up and Go (TUG) test is a validated timed functional test that involves standing up from a chair, walking forward for 3 meters, turning around, walking back to the chair for 3 meter, and sitting down. Each participant completed the TUG test for three trials. Time was measured using a stopwatch. Average and standard deviation of the time to complete the TUG test were calculated for each participant (each participant served as their own control in this pilot study).	Collection at baseline
Secondary	Timed Up and Go (TUG) Test	The Timed Up and Go (TUG) test is a validated timed functional test that involves standing up from a chair, walking forward for 3 meters, turning around, walking back to the chair for 3 meter, and sitting down. Each participant completed the TUG test for three trials. Time was measured using a stopwatch. Average and standard deviation of the time to complete the TUG test were calculated for each participant (each participant served as their own control in this pilot study).	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	Time to Complete Stand-to-Sit	The amount of time, measured in seconds, needed by the subject to complete the stand-to-sit transition. At least four trials of the stand-to-sit maneuver were collected for each participant using a motion analysis system. Average and standard deviation of the time to complete the stand-to-sit 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 being seated on a chair.	Collection at baseline
Secondary	Time to Complete Stand-to-Sit	The amount of time, measured in seconds, needed by the subject to complete the stand-to-sit transition. At least four trials of the stand-to-sit maneuver were collected for each participant using a motion analysis system. Average and standard deviation of the time to complete the stand-to-sit 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 being seated on a chair.	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	Percentage of Body Weight on Contralateral Limb at 65 Degrees Knee Flexion	The percentage of body weight on the contralateral limb was determined for both stand-to-sit and sit-to-stand transitions at 65 degrees knee flexion. A force plate under the contralateral limb recorded the amount of loading on the limb during the stand-to-sit and sit-to-stand transitions. The amount of contralateral limb loading at 65 degrees knee flexion was determined and divided by the participant's total loading due to overall body weight. This value was then converted to a percentage.	Collection at baseline
Secondary	Percentage of Body Weight on Contralateral Limb at 65 Degrees Knee Flexion	The percentage of body weight on the contralateral limb was determined for both stand-to-sit and sit-to-stand transitions at 65 degrees knee flexion. A force plate under the contralateral limb recorded the amount of loading on the limb during the stand-to-sit and sit-to-stand transitions. The amount of contralateral limb loading at 65 degrees knee flexion was determined and divided by the participant's total loading due to overall body weight. This value was then converted to a percentage.	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.)