Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 1R43HD097826 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
Not provided
Not provided
Not provided
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 .
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Habitual Prosthesis | Active Comparator | Participant's prescribed prosthesis |
|
| Assist-Knee | Experimental | Experimental knee prosthesis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Assist-Knee | Device | Assist-Knee is an experimental lower limb knee prosthesis. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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.) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sarah Chang, PhD | Orthocare Innovations, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthocare Innovations, LLC | Edmonds | Washington | 98020 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Individuals were recruited from a sample of convenience in the local area between 07/15/2019 and 02/26/2020.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Habitual Prosthesis | Participant's prescribed prosthesis Habitual Prosthesis: Habitual baseline prosthesis prescribed by participant's clinician. |
| FG001 | Assist-Knee (Settings 1) | Experimental knee prosthesis Assist-Knee: Assist-Knee is an experimental lower limb knee prosthesis. Settings 1: First set of settings tested on Assist-Knee with the participant. |
| FG002 | Assist-Knee (Settings 2) | Experimental knee prosthesis Assist-Knee: Assist-Knee is an experimental lower limb knee prosthesis. Settings 2: Second set of settings tested on Assist-Knee with the participant. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Habitual Prosthesis Condition |
| |||||||||||||
| Assist-Knee (Settings 1) Condition |
| |||||||||||||
| Assist-Knee (Settings 2) Condition |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Study Participants | Study participants completed both arms of the study: Habitual and Assist-Knee. Habitual Prosthesis: Habitual baseline prosthesis prescribed by participant's clinician. Assist-Knee Prosthesis: Assist-Knee is an experimental lower limb knee prosthesis. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Each participant served as their own control in this analysis. | Posted | Mean | Standard Deviation | seconds | Collection at baseline |
|
Adverse event data were collected during the experimental sessions with each participant, up to 3 hours.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Study Participants | Study participants completed both arms of the study: Habitual and Assist-Knee. Habitual Prosthesis: Habitual baseline prosthesis prescribed by participant's clinician. Assist-Knee Prosthesis: Assist-Knee is an experimental lower limb knee prosthesis. |
Not provided
Not provided
This clinical trial collected data with a small number of participants. These results may not be generalizable to the entire population. Furthermore, this clinical trial used the Assist-Knee experimental prototype which is in a proof-of-concept stage. There is a potential for the outcome measures to improve as the Assist-Knee device design is refined through development.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sarah Chang | Orthocare Innovations, LLC | 425-771-0797 | 1007 | schang@orthocareinnovations.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 15, 2019 | Sep 6, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 6, 2022 | Oct 4, 2022 | SAP_001.pdf |
Not provided
Crossover clinical trial
Not provided
Not provided
Not provided
Not provided
| Habitual Prosthesis |
| Device |
Habitual baseline prosthesis prescribed by participant's clinician. |
|
| 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). | 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. | 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. | 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. | 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. | 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.) |
| NOT COMPLETED |
|
| NOT COMPLETED |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| 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. | Each participant served as their own control in this analysis. | Posted | Mean | Standard Deviation | seconds | 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). | Each participant served as their own control in this analysis. | Posted | Mean | Standard Deviation | seconds | 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). | Each participant served as their own control in this analysis. | Posted | Mean | Standard Deviation | seconds | 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. | Each participant served as their own control in this analysis. | Posted | Mean | Standard Deviation | seconds | 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. | Each participant served as their own control in this analysis. | Posted | Mean | Standard Deviation | seconds | 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. | Each participant served as their own control in this analysis. | Posted | Mean | Standard Deviation | % body weight | 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. | Each participant served as their own control in this analysis. | Posted | Mean | Standard Deviation | % body weight | 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.) |
|
|
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
Not provided
Not provided
Not provided
| Participant B |
|
|
| Participant C |
|
|
|
| Participant C |
|
|
| Participant B |
|
|
| Participant C |
|
|
|
| Participant C |
|
|
| Participant B |
|
|
| Participant C |
|
|
| Participant B |
|
|
| Participant C |
|
|
|
| Participant B |
|
|
| Participant C |
|
|