An interventional study of Assist-Knee and Habitual Prosthesis in Transfemoral Amputation and Artificial Limbs, sponsored by Orthocare Innovations, LLC. Completed at 1 site in United States. Open to participants aged 21 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-10-18.
Sponsored by Orthocare Innovations, LLC · Not applicable, Interventional, and Device feasibility
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 .
Orthocare Innovations, LLC is the lead sponsor of 7 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participant's prescribed prosthesis
Device: Habitual Prosthesis
Experimental knee prosthesis
Device: Assist-Knee
Assist-Knee is an experimental lower limb knee prosthesis.
Habitual baseline prosthesis prescribed by participant's clinician.
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.
Time frame: Collection at baseline
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.
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.)
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).
Time frame: Collection at baseline
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).
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.)
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.
Time frame: Collection at baseline
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.
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.)
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.
Time frame: Collection at baseline
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.
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.)
Individuals were recruited from a sample of convenience in the local area between 07/15/2019 and 02/26/2020.
| Milestone | Habitual Prosthesis | Assist-Knee (Settings 1) | Assist-Knee (Settings 2) |
|---|---|---|---|
| Started | 3 | 0 | 0 |
| Completed | 3 | 0 | 0 |
| Not completed | 0 | 0 | 0 |
| Milestone | Habitual Prosthesis | Assist-Knee (Settings 1) | Assist-Knee (Settings 2) |
|---|---|---|---|
| Started | 0 | 3 | 0 |
| Completed | 0 | 3 | 0 |
| Not completed | 0 | 0 | 0 |
| Milestone | Habitual Prosthesis | Assist-Knee (Settings 1) | Assist-Knee (Settings 2) |
|---|---|---|---|
| Started | 0 | 0 | 3 |
| Completed | 0 | 0 | 3 |
| Not completed | 0 | 0 | 0 |
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.
| seconds | Habitual Prosthesis |
|---|---|
| Participant A | 1.6 ± 0.1 |
| Participant B | 2.2 ± 0.2 |
| Participant C | 1.4 ± 0.2 |
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.
| seconds | Assist-Knee (Settings 1) | Assist-Knee (Settings 2) |
|---|---|---|
| Participant A | 3.4 ± 0.6 | 2.7 ± 0.2 |
| Participant B | 6.4 ± 1.3 | 3.8 ± 0.5 |
| Participant C | 2.4 ± 0.5 | 2.9 ± 0.5 |
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).
| seconds | Habitual Prosthesis |
|---|---|
| Participant A | 7.1 ± 0.5 |
| Participant B | 13.7 ± 1.0 |
| Participant C | 12.3 ± 0.8 |
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).
| seconds | Assist-Knee (Settings 1) | Assist-Knee (Settings 2) |
|---|---|---|
| Participant A | 12.3 ± 1.1 | 12.8 ± 0.8 |
| Participant B | 25.0 ± 3.0 | 22.0 ± 1.4 |
| Participant C | 20.8 ± 3.5 | 18.8 ± 1.5 |
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.
| seconds | Habitual Prosthesis |
|---|---|
| Participant A | 2.7 ± 0.1 |
| Participant B | 4.1 ± 1.0 |
| Participant C | 1.6 ± 0.2 |
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.
| seconds | Assist-Knee (Settings 1) | Assist-Knee (Settings 2) |
|---|---|---|
| Participant A | 4.4 ± 0.4 | 3.3 ± 0.4 |
| Participant B | 4.9 ± 1.7 | 4.5 ± 0.9 |
| Participant C | 2.5 ± 0.1 | 2.7 ± 0.7 |
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.
| % body weight | SIT With Habitual Prosthesis | STAND With Habitual Prosthesis |
|---|---|---|
| Participant A | 79.2 ± 2.8 | 85.9 ± 2.5 |
| Participant B | 61.8 ± 11.4 | 49.0 ± 2.3 |
| Participant C | 87.0 ± 3.6 | 95.8 ± 2.6 |
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.
| % body weight | SIT With Assist-Knee (Settings 1) | STAND With Assist-Knee (Settings 1) | SIT With Assist-Knee (Settings 2) | STAND With Assist-Knee (Settings 2) |
|---|---|---|---|---|
| Participant A | 67.7 ± 7.5 | 82.0 ± 1.9 | 48.0 ± 9.4 | 83.5 ± 1.2 |
| Participant B | 23.5 ± 13.7 | 27.0 ± 6.9 | 19.4 ± 10.4 | 31.3 ± 2.3 |
| Participant C | 67.0 ± 1.6 | 78.6 ± 4.5 | 63.4 ± 9.9 | 76.4 ± 3.2 |
Collected over Adverse event data were collected during the experimental sessions with each participant, up to 3 hours.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Study Participants | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) |
| Age, Categorical(Participants) | Study Participants |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 1 |
| >=65 years | 2 |
| Age, Continuous(years) | Study Participants |
|---|---|
| Mean | 69 ± 5 |
| Sex: Female, Male(Participants) | Study Participants |
|---|---|
| Female | 2 |
| Male | 1 |
| Ethnicity (NIH/OMB)(Participants) | Study Participants |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 3 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Study Participants |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 3 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Study Participants |
|---|---|
| United States | 3 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Orthocare Innovations, LLC