Trial Outcomes & Findings for EmPOWERing Active Seniors With Energy (NCT NCT02958553)
NCT ID: NCT02958553
Last Updated: 2020-04-24
Results Overview
The proportion of patients with a clinically meaningful change (improvement, no change, worsening) in the walking distance measured by the Six Minute Walk Test (6MWT). 6minWT improvement was defined as a minimum increase of 45 meters.
COMPLETED
NA
8 participants
3 months with the emPOWER ankle
2020-04-24
Participant Flow
The EmPOWERing Active Seniors with Energy Study first subject was enrolled February 10, 2017. The last subject was enrolled November 6, 2017. All subjects were enrolled at a single study site which was a lower-limb rehabilitation clinic.
Participant milestones
| Measure |
emPOWER Ankle (Powered Prosthesis)
The subject's own passive prosthesis will be used as a baseline and crossed over after the emPOWER has been worn 3-4 months. Then the passive foot will be crossed back to the emPOWER for a final series of tests.
emPOWER Ankle: The device is 510k cleared and is intended to replace a missing foot and ankle. The emPOWER Ankle is to be used exclusively for fittings of lower-extremity amputations as prescribed by a healthcare professional.
Subject's own passive prosthesis: Devices will vary. Data gathered will form a baseline.
|
|---|---|
|
Phase I, 1st Visit -Passive Prosthesis
STARTED
|
8
|
|
Phase I, 1st Visit -Passive Prosthesis
COMPLETED
|
8
|
|
Phase I, 1st Visit -Passive Prosthesis
NOT COMPLETED
|
0
|
|
Phase I, 2nd Visit -Fitted With emPOWER
STARTED
|
8
|
|
Phase I, 2nd Visit -Fitted With emPOWER
COMPLETED
|
8
|
|
Phase I, 2nd Visit -Fitted With emPOWER
NOT COMPLETED
|
0
|
|
Phase I, 3rd Visit -2 Week emPOWER FU
STARTED
|
8
|
|
Phase I, 3rd Visit -2 Week emPOWER FU
COMPLETED
|
7
|
|
Phase I, 3rd Visit -2 Week emPOWER FU
NOT COMPLETED
|
1
|
|
Phase II, 4th Visit -3 Month emPOWER FU
STARTED
|
7
|
|
Phase II, 4th Visit -3 Month emPOWER FU
COMPLETED
|
4
|
|
Phase II, 4th Visit -3 Month emPOWER FU
NOT COMPLETED
|
3
|
|
Phase II, 5th Visit -Crossover Visit
STARTED
|
4
|
|
Phase II, 5th Visit -Crossover Visit
COMPLETED
|
4
|
|
Phase II, 5th Visit -Crossover Visit
NOT COMPLETED
|
0
|
|
Phase II, 6th Visit -6 Month emPOWER FU
STARTED
|
4
|
|
Phase II, 6th Visit -6 Month emPOWER FU
COMPLETED
|
2
|
|
Phase II, 6th Visit -6 Month emPOWER FU
NOT COMPLETED
|
2
|
|
Phase II, 7th Visit -12 Month emPOWER FU
STARTED
|
2
|
|
Phase II, 7th Visit -12 Month emPOWER FU
COMPLETED
|
2
|
|
Phase II, 7th Visit -12 Month emPOWER FU
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
emPOWER Ankle (Powered Prosthesis)
The subject's own passive prosthesis will be used as a baseline and crossed over after the emPOWER has been worn 3-4 months. Then the passive foot will be crossed back to the emPOWER for a final series of tests.
emPOWER Ankle: The device is 510k cleared and is intended to replace a missing foot and ankle. The emPOWER Ankle is to be used exclusively for fittings of lower-extremity amputations as prescribed by a healthcare professional.
Subject's own passive prosthesis: Devices will vary. Data gathered will form a baseline.
|
|---|---|
|
Phase I, 3rd Visit -2 Week emPOWER FU
Withdrawal by Subject
|
1
|
|
Phase II, 6th Visit -6 Month emPOWER FU
Adverse Event
|
2
|
Baseline Characteristics
EmPOWERing Active Seniors With Energy
Baseline characteristics by cohort
| Measure |
emPOWER Ankle (Powered Prosthesis)
n=8 Participants
The subject's own passive prothesis will be used as a baseline and crossed over after the emPOWER has been worn for 3-4 months. Then the passive foot will be crossed back to the emPOWER for a final series of tests.
emPOWER Ankle: The deivce is 510k cleared and is intended to replace a missing foot and ankle. The emPOWER ankle is to be used exclusively for fittings of lower-extremity amputations as prescribed by a healthcare professional.
Subject's own passive prosthesis: Devices will vary. Data gathered will form a baseline.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
61.4 years
STANDARD_DEVIATION 7.97 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 months with the emPOWER anklePopulation: The results for the primary effectiveness endpoint for improvement in walking distance with the Empower compared to the distance walked with the subject's passive prosthesis as measured by the 6 minute Walk Test (6MWT) at 3 months from four subjects were available for analysis.
The proportion of patients with a clinically meaningful change (improvement, no change, worsening) in the walking distance measured by the Six Minute Walk Test (6MWT). 6minWT improvement was defined as a minimum increase of 45 meters.
Outcome measures
| Measure |
emPOWER Ankle (Powered Prosthesis)
n=4 Participants
The subject's own passive prosthesis will be used as a baseline and crossed over after the emPOWER has been worn 3-4 months. Then the passive foot will be crossed back to the emPOWER for a final series of tests.
emPOWER Ankle: The device is 510k cleared and is intended to replace a missing foot and ankle. The emPOWER Ankle is to be used exclusively for fittings of lower-extremity amputations as prescribed by a healthcare professional.
Subject's own passive prosthesis: Devices will vary. Data gathered will form a baseline.
|
|---|---|
|
Number of Participants With Improvement, No Change, or Worsening in Performance in the Six Minute Walk Test (6MWT)
Improved
|
1 Participants
|
|
Number of Participants With Improvement, No Change, or Worsening in Performance in the Six Minute Walk Test (6MWT)
No Change
|
3 Participants
|
|
Number of Participants With Improvement, No Change, or Worsening in Performance in the Six Minute Walk Test (6MWT)
Declined
|
0 Participants
|
SECONDARY outcome
Timeframe: 3 months with the emPOWER anklePopulation: The results for the secondary effectiveness endpoint for improvement in walking time with the Empower compared to the distance walked with the subject's passive prosthesis as measured by the 12 minute Walk Test (12MWT) at 3 months from four subjects were available for analysis.
The proportion of patients with a clinically meaningful change (improvement, no change, worsening) in the walking distance measured by the Twelve Minute Walk Test (12MWT). 12minWT improvement was defined as a minimum increase of 90 meters.
Outcome measures
| Measure |
emPOWER Ankle (Powered Prosthesis)
n=4 Participants
The subject's own passive prosthesis will be used as a baseline and crossed over after the emPOWER has been worn 3-4 months. Then the passive foot will be crossed back to the emPOWER for a final series of tests.
emPOWER Ankle: The device is 510k cleared and is intended to replace a missing foot and ankle. The emPOWER Ankle is to be used exclusively for fittings of lower-extremity amputations as prescribed by a healthcare professional.
Subject's own passive prosthesis: Devices will vary. Data gathered will form a baseline.
|
|---|---|
|
Number of Participants With Improvement, No Change, or Worsening in Performance in the Twelve Minute Walk Test (12MWT)
No Change
|
2 Participants
|
|
Number of Participants With Improvement, No Change, or Worsening in Performance in the Twelve Minute Walk Test (12MWT)
Improved
|
2 Participants
|
|
Number of Participants With Improvement, No Change, or Worsening in Performance in the Twelve Minute Walk Test (12MWT)
Declined
|
0 Participants
|
SECONDARY outcome
Timeframe: 3 months with the emPOWER anklePopulation: The results for the secondary effectiveness endpoint for improvement in walking distance with the Empower compared to the distance walked with the subject's passive prosthesis as measured by the 10MWT at 3 months from four subjects were available for analysis.
The proportion of patients with a clinically meaningful change (improvement, no change, worsening) in the walking distance measured by the 10 Meter Walk Test (10MWT). 10MWT improvement was defined as a minimum increase of 0.1 m/s.
Outcome measures
| Measure |
emPOWER Ankle (Powered Prosthesis)
n=4 Participants
The subject's own passive prosthesis will be used as a baseline and crossed over after the emPOWER has been worn 3-4 months. Then the passive foot will be crossed back to the emPOWER for a final series of tests.
emPOWER Ankle: The device is 510k cleared and is intended to replace a missing foot and ankle. The emPOWER Ankle is to be used exclusively for fittings of lower-extremity amputations as prescribed by a healthcare professional.
Subject's own passive prosthesis: Devices will vary. Data gathered will form a baseline.
|
|---|---|
|
Number of Participants With Improvement, No Change, or Worsening in Performance in the 10 Meter Walk Test (10MWT)
Improved
|
1 Participants
|
|
Number of Participants With Improvement, No Change, or Worsening in Performance in the 10 Meter Walk Test (10MWT)
No Change
|
3 Participants
|
|
Number of Participants With Improvement, No Change, or Worsening in Performance in the 10 Meter Walk Test (10MWT)
Declined
|
0 Participants
|
SECONDARY outcome
Timeframe: 3 months with the emPOWER anklePopulation: The results for the secondary effectiveness endpoint for improvement in walking distance with the Empower compared to the distance walked with the subject's passive prosthesis as measured by the L-Test at 3 months from four subjects were available for analysis.
The proportion of patients with a clinically meaningful change (improvement, no change, worsening) in the walking time measured in the L-Test. L-Test improvement was defined as a minimum decrease of 4.5 seconds.
Outcome measures
| Measure |
emPOWER Ankle (Powered Prosthesis)
n=4 Participants
The subject's own passive prosthesis will be used as a baseline and crossed over after the emPOWER has been worn 3-4 months. Then the passive foot will be crossed back to the emPOWER for a final series of tests.
emPOWER Ankle: The device is 510k cleared and is intended to replace a missing foot and ankle. The emPOWER Ankle is to be used exclusively for fittings of lower-extremity amputations as prescribed by a healthcare professional.
Subject's own passive prosthesis: Devices will vary. Data gathered will form a baseline.
|
|---|---|
|
Number of Participants With Improvement, No Change, or Worsening in Performance in the L-Test
Improved
|
0 Participants
|
|
Number of Participants With Improvement, No Change, or Worsening in Performance in the L-Test
No Change
|
4 Participants
|
|
Number of Participants With Improvement, No Change, or Worsening in Performance in the L-Test
Declined
|
0 Participants
|
SECONDARY outcome
Timeframe: 3 months with the emPOWER anklePopulation: The results for the secondary effectiveness endpoint for improvement in walking distance with the Empower compared to the distance walked with the subject's passive prosthesis as measured by the Ramp Test at 3 months from four subjects were available for analysis.
The proportion of patients with a clinically meaningful change (improvement, no change, worsening) in the walking time measured in theRamp Test. Ramp Test improvement was defined as a minimum decrease of 6 seconds to complete the test.
Outcome measures
| Measure |
emPOWER Ankle (Powered Prosthesis)
n=4 Participants
The subject's own passive prosthesis will be used as a baseline and crossed over after the emPOWER has been worn 3-4 months. Then the passive foot will be crossed back to the emPOWER for a final series of tests.
emPOWER Ankle: The device is 510k cleared and is intended to replace a missing foot and ankle. The emPOWER Ankle is to be used exclusively for fittings of lower-extremity amputations as prescribed by a healthcare professional.
Subject's own passive prosthesis: Devices will vary. Data gathered will form a baseline.
|
|---|---|
|
Number of Participants With Improvement, No Change, or Worsening in Performance in the Ramp Test
No Change
|
2 Participants
|
|
Number of Participants With Improvement, No Change, or Worsening in Performance in the Ramp Test
Improved
|
0 Participants
|
|
Number of Participants With Improvement, No Change, or Worsening in Performance in the Ramp Test
Declined
|
2 Participants
|
SECONDARY outcome
Timeframe: 3 months with the emPOWER anklePopulation: The results from four subjects were available for analysis for the secondary effectiveness endpoint for improvement in ABC scale with the Empower at 3 months compared to the ABC scale with the subject's passive prosthesis as measured by the ABC scale.
The proportion of patients with a clinically meaningful change (improvement, no change, worsening) in abulatory activities measured by the Activities-specific Balance Confidence Scale. Improvement in the ABC was defined as a minimum detectable change of 13% increase in score. The ABC Scale is a self-administered questionnaire that asks the patient to rate his or her confidence in performing various ambulatory activities on a scale from 0% (no confidence) to 100% (complete confidence) without losing balance or becoming unsteady. Scores for each of the 16 items will be collected and an average percentage calculated, with scores \<67 indicating an increased risk of falling.
Outcome measures
| Measure |
emPOWER Ankle (Powered Prosthesis)
n=4 Participants
The subject's own passive prosthesis will be used as a baseline and crossed over after the emPOWER has been worn 3-4 months. Then the passive foot will be crossed back to the emPOWER for a final series of tests.
emPOWER Ankle: The device is 510k cleared and is intended to replace a missing foot and ankle. The emPOWER Ankle is to be used exclusively for fittings of lower-extremity amputations as prescribed by a healthcare professional.
Subject's own passive prosthesis: Devices will vary. Data gathered will form a baseline.
|
|---|---|
|
Number of Participants With Improvement, No Change, or Worsening in Performance in the Activities-specific Balance Confidence (ABC) Scale Score
Improved
|
1 Participants
|
|
Number of Participants With Improvement, No Change, or Worsening in Performance in the Activities-specific Balance Confidence (ABC) Scale Score
No Change
|
3 Participants
|
|
Number of Participants With Improvement, No Change, or Worsening in Performance in the Activities-specific Balance Confidence (ABC) Scale Score
Declined
|
0 Participants
|
SECONDARY outcome
Timeframe: 3 months with the emPOWER anklePopulation: The results from four subjects were available for analysis for the secondary effectiveness endpoint for improvement in Falls Efficiacy scale with the Empower at 3 months compared to the Falls Efficiacy scale with the subject's passive prosthesis as measured by the Falls Efficiacy scale.
The Falls Efficacy Scale is a validated 10-item self-report questionnaire designed to assess confidence in the ability to perform 10 activities of daily living without falling as an indicator of how one's fear of falling impacts physical performance. Each item is rated from 1 ("very confident") to 10 ("not confident at all"), and the per item ratings are added to generate a summary total score (10 to 100). Lower scores indicate more confidence and higher scores indicate lack of confidence and greater fear of falling. It has been validated for use in the elderly and persons with amputations. Scores ≥70 indicate an increased fear of falling. Improvement in the Falls Efficiacy Scale was defined as a minimum increase of 2 in the score.
Outcome measures
| Measure |
emPOWER Ankle (Powered Prosthesis)
n=4 Participants
The subject's own passive prosthesis will be used as a baseline and crossed over after the emPOWER has been worn 3-4 months. Then the passive foot will be crossed back to the emPOWER for a final series of tests.
emPOWER Ankle: The device is 510k cleared and is intended to replace a missing foot and ankle. The emPOWER Ankle is to be used exclusively for fittings of lower-extremity amputations as prescribed by a healthcare professional.
Subject's own passive prosthesis: Devices will vary. Data gathered will form a baseline.
|
|---|---|
|
Number of Participants With Improvement, No Change, or Worsening in Performance in the Falls Efficacy Scale Score
Improved
|
1 Participants
|
|
Number of Participants With Improvement, No Change, or Worsening in Performance in the Falls Efficacy Scale Score
No Improvement
|
3 Participants
|
|
Number of Participants With Improvement, No Change, or Worsening in Performance in the Falls Efficacy Scale Score
Declined
|
0 Participants
|
SECONDARY outcome
Timeframe: 3 months with the emPOWER anklePopulation: The results from four subjects were available for analysis for the secondary effectiveness endpoint for improvement in AMP with the Empower at 3 months compared to the AMP with the subject's passive prosthesis as measured by the AMP Assessment.
The AMP is an instrument designed to measure ambulatory potential of lower-limb amputees. Subjects begin the test seated in a hard chair with arms and are tested for a total of 21 items assessing abilities of increasing level of difficulty. Abilities assessed include sitting balance, transfer from chair to chair, standing balance, gait quality, negotiating obstacles, and the use of assistive devices. The total score range for the AMP is 0 to 47 points. A minimal detectable change of 4 points was the definition of improvement.
Outcome measures
| Measure |
emPOWER Ankle (Powered Prosthesis)
n=4 Participants
The subject's own passive prosthesis will be used as a baseline and crossed over after the emPOWER has been worn 3-4 months. Then the passive foot will be crossed back to the emPOWER for a final series of tests.
emPOWER Ankle: The device is 510k cleared and is intended to replace a missing foot and ankle. The emPOWER Ankle is to be used exclusively for fittings of lower-extremity amputations as prescribed by a healthcare professional.
Subject's own passive prosthesis: Devices will vary. Data gathered will form a baseline.
|
|---|---|
|
Number of Participants With Improvement, No Change, or Worsening in Performance in the Amputee Mobility Predictor (AMP) Assessment
Improved
|
0 Participants
|
|
Number of Participants With Improvement, No Change, or Worsening in Performance in the Amputee Mobility Predictor (AMP) Assessment
No Change
|
4 Participants
|
|
Number of Participants With Improvement, No Change, or Worsening in Performance in the Amputee Mobility Predictor (AMP) Assessment
Declined
|
0 Participants
|
SECONDARY outcome
Timeframe: 3 months with the emPOWER anklePopulation: The results from four subjects were available for analysis for the secondary effectiveness endpoint for improvement in PLUS-M with the Empower at 3 months compared to the PLUS-M with the subject's passive prosthesis as measured by the PLUS-M measure.
The PLUS-M is a valid and reliable self-reported measure for the mobility of adults with lower limb amputations. PLUS-M asks about the patient's ability to perform simple and complex tasks. High PLUS-M scores correspond with greater mobility. Improvement in the Mobility PLUS-M (12 item Short Form) was defined by a minimum detectable change of an increase of 5 points in the total score.
Outcome measures
| Measure |
emPOWER Ankle (Powered Prosthesis)
n=4 Participants
The subject's own passive prosthesis will be used as a baseline and crossed over after the emPOWER has been worn 3-4 months. Then the passive foot will be crossed back to the emPOWER for a final series of tests.
emPOWER Ankle: The device is 510k cleared and is intended to replace a missing foot and ankle. The emPOWER Ankle is to be used exclusively for fittings of lower-extremity amputations as prescribed by a healthcare professional.
Subject's own passive prosthesis: Devices will vary. Data gathered will form a baseline.
|
|---|---|
|
Number of Participants With Improvement, No Change, or Worsening in Performance in the Prosthetic Limb Users Survey of Mobility PLUS-M (12 Item Short Form)
Improved
|
1 Participants
|
|
Number of Participants With Improvement, No Change, or Worsening in Performance in the Prosthetic Limb Users Survey of Mobility PLUS-M (12 Item Short Form)
No Change
|
3 Participants
|
|
Number of Participants With Improvement, No Change, or Worsening in Performance in the Prosthetic Limb Users Survey of Mobility PLUS-M (12 Item Short Form)
Declined
|
0 Participants
|
SECONDARY outcome
Timeframe: 3 months with the emPOWER anklePopulation: While 4 subjects completed the PSFS, the results from only one subject were available for analysis, since 3 subjects rated different goals at each time point. The secondary effectiveness endpoint was improvement in PSFS with the Empower at 3 months compared to the PSFS with the subject's passive prosthesis as measured by the PSFS.
The PSFS is a self-report, goal-attainment measure aimed at identifying functional status limitations that are most relevant to individual patients. The PSFS is a reliable, valid, and efficient measure for detecting clinical change in persons with low back pain and knee dysfunction. Subjects were asked to identify three to five activities that they are having difficulty or are unable to perform because of their injury/condition. For the specified activities, patients were asked to rate their ability to perform each activity at that time (0-10 numerical scale) with '0' being unable to perform the activity, and '10' being able to perform the activity at the same level as they could prior to the injury/condition. The total score was calculated as the sum of the activity scores divided by the number of activities. Changes of \>2 in the total score compared to baseline were considered "Improved."
Outcome measures
| Measure |
emPOWER Ankle (Powered Prosthesis)
n=1 Participants
The subject's own passive prosthesis will be used as a baseline and crossed over after the emPOWER has been worn 3-4 months. Then the passive foot will be crossed back to the emPOWER for a final series of tests.
emPOWER Ankle: The device is 510k cleared and is intended to replace a missing foot and ankle. The emPOWER Ankle is to be used exclusively for fittings of lower-extremity amputations as prescribed by a healthcare professional.
Subject's own passive prosthesis: Devices will vary. Data gathered will form a baseline.
|
|---|---|
|
Number of Participants With Improvement, No Change, or Worsening in Performance in the Patient Specific Functional Scale (PSFS)
Worsened
|
0 Participants
|
|
Number of Participants With Improvement, No Change, or Worsening in Performance in the Patient Specific Functional Scale (PSFS)
Improved
|
1 Participants
|
|
Number of Participants With Improvement, No Change, or Worsening in Performance in the Patient Specific Functional Scale (PSFS)
No Change
|
0 Participants
|
SECONDARY outcome
Timeframe: 3 months with the emPOWER anklePopulation: The results from four subjects were available for analysis for the secondary effectiveness endpoint for improvement in NPRS with the Empower at 3 months compared to the NPRS with the subject's passive prosthesis as measured by the NPRS.
The NPRS is a valid and reliable measure of pain that may be used across all musculoskeletal injuries/conditions and complements the PSFS. The patient was asked to rate the pain of their joints, foot, lower back, and if they are using an assistive device any additional affected limbs on average over the last 24 hours on a scale 1-10, with '1' being 'very mild' and '10' being the 'unimaginable unspeakable'. The scores on the NPRS instruments with the emPOWER Ankle were compared to the scores on the subject's passive prosthesis. An improvement was considered a positive change of 1 for at least one area without a corresponding decrease in another.
Outcome measures
| Measure |
emPOWER Ankle (Powered Prosthesis)
n=4 Participants
The subject's own passive prosthesis will be used as a baseline and crossed over after the emPOWER has been worn 3-4 months. Then the passive foot will be crossed back to the emPOWER for a final series of tests.
emPOWER Ankle: The device is 510k cleared and is intended to replace a missing foot and ankle. The emPOWER Ankle is to be used exclusively for fittings of lower-extremity amputations as prescribed by a healthcare professional.
Subject's own passive prosthesis: Devices will vary. Data gathered will form a baseline.
|
|---|---|
|
Number of Participants With Improvement, No Change, or Worsening in Performance in the Numeric Pain Rating Scale (NPRS)
Improved
|
2 Participants
|
|
Number of Participants With Improvement, No Change, or Worsening in Performance in the Numeric Pain Rating Scale (NPRS)
No Change
|
1 Participants
|
|
Number of Participants With Improvement, No Change, or Worsening in Performance in the Numeric Pain Rating Scale (NPRS)
Declined
|
1 Participants
|
SECONDARY outcome
Timeframe: 3 months with the emPOWER anklePopulation: The results from four subjects were available for analysis for the secondary effectiveness endpoint for improvement in activity with the Empower at 3 months compared to the activity with the subject's passive prosthesis as measured by the steps counts from the Fitbit Activity Monitor.
A Fitbit activity monitor was worn to record the number of steps the Subject took with the prosthesis. The patient returned to the site with the activity monitor and the steps counted were downloaded from the device. In addition, the Subjects were sent home with a prepaid envelope and instructed to mail back the activity monitor if the next visit was more than 3 weeks later, to ensure that the data was not lost. The step counts were downloaded from the device the day the activity monitor was returned to the Investigator. The Investigator recorded the date the patient was affixed with the activity monitor, the date they received the returned activity monitor, and the date they synced the monitor. An improvement was defined as an increase in the average daily step count of 750 steps.
Outcome measures
| Measure |
emPOWER Ankle (Powered Prosthesis)
n=3 Participants
The subject's own passive prosthesis will be used as a baseline and crossed over after the emPOWER has been worn 3-4 months. Then the passive foot will be crossed back to the emPOWER for a final series of tests.
emPOWER Ankle: The device is 510k cleared and is intended to replace a missing foot and ankle. The emPOWER Ankle is to be used exclusively for fittings of lower-extremity amputations as prescribed by a healthcare professional.
Subject's own passive prosthesis: Devices will vary. Data gathered will form a baseline.
|
|---|---|
|
Number of Participants With Improvement, No Change, or Worsening in Performance in Activity (Monitoring Using a Fitbit Over 2-week Periods)
Improved
|
0 Participants
|
|
Number of Participants With Improvement, No Change, or Worsening in Performance in Activity (Monitoring Using a Fitbit Over 2-week Periods)
No Change
|
1 Participants
|
|
Number of Participants With Improvement, No Change, or Worsening in Performance in Activity (Monitoring Using a Fitbit Over 2-week Periods)
Declined
|
2 Participants
|
SECONDARY outcome
Timeframe: 3 months with the emPOWER anklePopulation: The results from four subjects were available for analysis for the secondary effectiveness endpoint for improvement in PROMIS Physical Function with the Empower at 3 months compared to PROMIS Physical Function with the subject's passive prosthesis as measured by the PROMIS Physical Function.
PROMIS item banks and their short forms are a reliable and precise measurements of patient reported outcome measures. The scores on the PROMIS instruments with the emPOWER Ankle 3 months after fitting will be compared to the scores on the subject's passive prosthesis. PROMIS Physical Function improvement was defined as a minimally clinically important difference (MCID) of an increase of 6.8 in a total score.
Outcome measures
| Measure |
emPOWER Ankle (Powered Prosthesis)
n=4 Participants
The subject's own passive prosthesis will be used as a baseline and crossed over after the emPOWER has been worn 3-4 months. Then the passive foot will be crossed back to the emPOWER for a final series of tests.
emPOWER Ankle: The device is 510k cleared and is intended to replace a missing foot and ankle. The emPOWER Ankle is to be used exclusively for fittings of lower-extremity amputations as prescribed by a healthcare professional.
Subject's own passive prosthesis: Devices will vary. Data gathered will form a baseline.
|
|---|---|
|
Number of Participants With Improvement, No Change, or Worsening in Performance in PROMIS Physical Function
Improved
|
2 Participants
|
|
Number of Participants With Improvement, No Change, or Worsening in Performance in PROMIS Physical Function
No Change
|
2 Participants
|
|
Number of Participants With Improvement, No Change, or Worsening in Performance in PROMIS Physical Function
Declined
|
0 Participants
|
SECONDARY outcome
Timeframe: 3 months with the emPOWER anklePopulation: The results from four subjects were available for analysis for the secondary effectiveness endpoint for improvement in PROMIS Global Health with the Empower at 3 months compared to PROMIS Global Health with the subject's passive prosthesis as measured by the PROMIS Global Health Short Form.
PROMIS item banks and their short forms are a reliable and precise measurements of patient reported outcome measures. The scores on the PROMIS instruments with the emPOWER Ankle 3 months after fitting will be compared to the scores on the subject's passive prosthesis. PROMIS Global Health Short Form improvement was defined as an increase in a total score of 3.5.
Outcome measures
| Measure |
emPOWER Ankle (Powered Prosthesis)
n=4 Participants
The subject's own passive prosthesis will be used as a baseline and crossed over after the emPOWER has been worn 3-4 months. Then the passive foot will be crossed back to the emPOWER for a final series of tests.
emPOWER Ankle: The device is 510k cleared and is intended to replace a missing foot and ankle. The emPOWER Ankle is to be used exclusively for fittings of lower-extremity amputations as prescribed by a healthcare professional.
Subject's own passive prosthesis: Devices will vary. Data gathered will form a baseline.
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|---|---|
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Number of Participants With Improvement, No Change, or Worsening in Performance in PROMIS Global Health Short Form
Improved
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1 Participants
|
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Number of Participants With Improvement, No Change, or Worsening in Performance in PROMIS Global Health Short Form
No Change
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3 Participants
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Number of Participants With Improvement, No Change, or Worsening in Performance in PROMIS Global Health Short Form
Declined
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0 Participants
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SECONDARY outcome
Timeframe: 3 months with the emPOWER anklePopulation: The results from four subjects were available for analysis for the secondary effectiveness endpoint for improvement in PROMIS Fatigue with the Empower at 3 months compared to PROMIS Fatigue with the subject's passive prosthesis as measured by the PROMIS Fatigue Short Form (7a).
PROMIS item banks and their short forms are a reliable and precise measurements of patient reported outcome measures. The scores on the PROMIS instruments with the emPOWER Ankle 3 months after fitting will be compared to the scores on the subject's passive prosthesis. PROMIS Fatigue Short Form (7a) improvement was defined as a minimally clinically important difference (MCID) of an increase of 5 in a total score.
Outcome measures
| Measure |
emPOWER Ankle (Powered Prosthesis)
n=4 Participants
The subject's own passive prosthesis will be used as a baseline and crossed over after the emPOWER has been worn 3-4 months. Then the passive foot will be crossed back to the emPOWER for a final series of tests.
emPOWER Ankle: The device is 510k cleared and is intended to replace a missing foot and ankle. The emPOWER Ankle is to be used exclusively for fittings of lower-extremity amputations as prescribed by a healthcare professional.
Subject's own passive prosthesis: Devices will vary. Data gathered will form a baseline.
|
|---|---|
|
Number of Participants With Improvement, No Change, or Worsening in Performance in PROMIS Fatigue Short Form (7a)
Improved
|
1 Participants
|
|
Number of Participants With Improvement, No Change, or Worsening in Performance in PROMIS Fatigue Short Form (7a)
No Change
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3 Participants
|
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Number of Participants With Improvement, No Change, or Worsening in Performance in PROMIS Fatigue Short Form (7a)
Declined
|
0 Participants
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SECONDARY outcome
Timeframe: 3 months with the emPOWER anklePopulation: The results from four subjects were available for analysis for the secondary effectiveness endpoint for improvement in Pain Intensity with the Empower at 3 months compared to Pain Intensity with the subject's passive prosthesis as measured by the Pain Intensity Short Form (3a).
PROMIS item banks and their short forms are a reliable and precise measurements of patient reported outcome measures. The scores on the PROMIS instruments with the emPOWER Ankle 3 months after fitting will be compared to the scores on the subject's passive prosthesis. PROMIS Pain Intensity Short Form (3a) improvement was defined as a minimally clinically important difference (MCID) of an increase of 6.9 in a total score.
Outcome measures
| Measure |
emPOWER Ankle (Powered Prosthesis)
n=4 Participants
The subject's own passive prosthesis will be used as a baseline and crossed over after the emPOWER has been worn 3-4 months. Then the passive foot will be crossed back to the emPOWER for a final series of tests.
emPOWER Ankle: The device is 510k cleared and is intended to replace a missing foot and ankle. The emPOWER Ankle is to be used exclusively for fittings of lower-extremity amputations as prescribed by a healthcare professional.
Subject's own passive prosthesis: Devices will vary. Data gathered will form a baseline.
|
|---|---|
|
Number of Participants With Improvement, No Change, or Worsening in Performance in PROMIS Pain Intensity Short Form (3a)
Improved
|
1 Participants
|
|
Number of Participants With Improvement, No Change, or Worsening in Performance in PROMIS Pain Intensity Short Form (3a)
No Change
|
3 Participants
|
|
Number of Participants With Improvement, No Change, or Worsening in Performance in PROMIS Pain Intensity Short Form (3a)
Declined
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0 Participants
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OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsPopulation: Daily step counts were collected and reported for Secondary Outcome 12. Any reported falls were collected and reported as Adverse Events. Patient diaries were not collected, and no analysis was possible for other data recorded, such as daily activity.
Self-Report Diary: Falls and daily activity. This was used to capture daily step counts from the Fitbit, daily activity and adverse events. It was a data collection tool, but was originally named as an Secondary Outcome.
Outcome measures
Outcome data not reported
Adverse Events
emPOWER Ankle (Powered Prosthesis)
Subject's Own Passive Prosthesis
Serious adverse events
| Measure |
emPOWER Ankle (Powered Prosthesis)
n=8 participants at risk
emPOWER Ankle: The device is 510k cleared and is intended to replace a missing foot and ankle. The emPOWER Ankle is to be used exclusively for fittings of lower-extremity amputations as prescribed by a healthcare professional.
The subjects were fit with the emPOWER Ankle and followed for 3-4 months. After crossing over the passive foot and wearing it for 2 weeks, the subjects crossed over back to wearing the emPOWER Ankle up to the 12 months after the initial fitting.
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Subject's Own Passive Prosthesis
n=4 participants at risk
Subject's own passive prosthesis: Devices varied.
The subject's own passive prosthesis was used as a baseline/control. No adverse events were collected prior to initial fitting with the emPOWER Ankle. After wearing the emPOWER Ankle for 3-4 months, subjects crossed over back to the passive prosthesis and wore it for 2 weeks. Subjects were crossed over back to the emPOWER for long-term follow up, up to 12 months after the initial fitting.
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Endocrine disorders
Pancreatitis and ketoacidosis
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12.5%
1/8 • Number of events 1 • Adverse Events were collected from the time of informed consent through study completion for each study subject, up to 12 months. All adverse events were monitored until they are adequately resolved, explained or the subject has exited the study.
Definitions match clinicaltrials.gov
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0.00%
0/4 • Adverse Events were collected from the time of informed consent through study completion for each study subject, up to 12 months. All adverse events were monitored until they are adequately resolved, explained or the subject has exited the study.
Definitions match clinicaltrials.gov
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Cardiac disorders
Angioplasty
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12.5%
1/8 • Number of events 1 • Adverse Events were collected from the time of informed consent through study completion for each study subject, up to 12 months. All adverse events were monitored until they are adequately resolved, explained or the subject has exited the study.
Definitions match clinicaltrials.gov
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0.00%
0/4 • Adverse Events were collected from the time of informed consent through study completion for each study subject, up to 12 months. All adverse events were monitored until they are adequately resolved, explained or the subject has exited the study.
Definitions match clinicaltrials.gov
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Other adverse events
| Measure |
emPOWER Ankle (Powered Prosthesis)
n=8 participants at risk
emPOWER Ankle: The device is 510k cleared and is intended to replace a missing foot and ankle. The emPOWER Ankle is to be used exclusively for fittings of lower-extremity amputations as prescribed by a healthcare professional.
The subjects were fit with the emPOWER Ankle and followed for 3-4 months. After crossing over the passive foot and wearing it for 2 weeks, the subjects crossed over back to wearing the emPOWER Ankle up to the 12 months after the initial fitting.
|
Subject's Own Passive Prosthesis
n=4 participants at risk
Subject's own passive prosthesis: Devices varied.
The subject's own passive prosthesis was used as a baseline/control. No adverse events were collected prior to initial fitting with the emPOWER Ankle. After wearing the emPOWER Ankle for 3-4 months, subjects crossed over back to the passive prosthesis and wore it for 2 weeks. Subjects were crossed over back to the emPOWER for long-term follow up, up to 12 months after the initial fitting.
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|---|---|---|
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Skin and subcutaneous tissue disorders
Blisters
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25.0%
2/8 • Number of events 2 • Adverse Events were collected from the time of informed consent through study completion for each study subject, up to 12 months. All adverse events were monitored until they are adequately resolved, explained or the subject has exited the study.
Definitions match clinicaltrials.gov
|
0.00%
0/4 • Adverse Events were collected from the time of informed consent through study completion for each study subject, up to 12 months. All adverse events were monitored until they are adequately resolved, explained or the subject has exited the study.
Definitions match clinicaltrials.gov
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General disorders
Falls
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37.5%
3/8 • Number of events 3 • Adverse Events were collected from the time of informed consent through study completion for each study subject, up to 12 months. All adverse events were monitored until they are adequately resolved, explained or the subject has exited the study.
Definitions match clinicaltrials.gov
|
0.00%
0/4 • Adverse Events were collected from the time of informed consent through study completion for each study subject, up to 12 months. All adverse events were monitored until they are adequately resolved, explained or the subject has exited the study.
Definitions match clinicaltrials.gov
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60