Trial Outcomes & Findings for Determining the Potential Benefit of Powered Prostheses (NCT NCT02828982)
NCT ID: NCT02828982
Last Updated: 2022-01-18
Results Overview
Metabolic costs will be measured using a portable metabolic system when participants walk on a treadmill at a fixed speed.
COMPLETED
NA
12 participants
Testing took place after wearing the prostheses for two weeks
2022-01-18
Participant Flow
Recruitment began after initial approval from the University of Michigan IRB (July 2016). Participants were recruited through the University of Michigan Orthotics and Prosthetics Clinic by a study physician and study prosthetist in-person, through phone or email, or with flyers.
Participants were asked to complete both arms of the study. Before starting, participants were randomly enrolled in the dynamic response foot (unpowered prosthesis) or powered condition to start with. Some participants completed both arms while others only finished one of the arms.
Participant milestones
| Measure |
Powered Ankle Prosthesis, Then Unpowered Prosthesis
In this condition, the participant was fitted with a powered prosthetic ankle by a certified prosthetist to start the study. The ankle is the BiOM which is manufactured by Bionx (which used to be named iWalk). This device was given 510(K) Exempt status by the FDA under (regulation number: 890.3500). Participants had at least one week to acclimate to the prosthesis. They then will wore the device for 2 weeks at home, while their activity was monitored. They then came to the lab for testing. The powered prosthesis was removed and their prescribed prosthetic foot was reattached to their existing socket. They then wore their prescribed prosthesis for 2 weeks, while their activity was monitored, before returning to the lab for testing.
|
Unpowered Prosthesis, Then Powered Ankle Prosthesis
In this arm, participants will start in their clinically prescribed dynamic response foot. They first wore their prescribed prosthesis for 2 weeks, while their activity was monitored. They then came to the laboratory for testing. Participants were then fitted with a powered prosthetic ankle by a certified prosthetist. The ankle is the BiOM which is manufactured by Bionx (which used to be named iWalk). This device was given 510(K) Exempt status by the FDA under (regulation number: 890.3500). Participants had at least one week to acclimate to the prosthesis. They then will wore the device for 2 weeks at home, while their activity was monitored. They then came to the lab for testing. The powered prosthesis was removed and their prescribed prosthetic foot was reattached to their existing socket.
|
|---|---|---|
|
First Intervention (3 Weeks)
STARTED
|
5
|
7
|
|
First Intervention (3 Weeks)
Received Intervention
|
5
|
7
|
|
First Intervention (3 Weeks)
COMPLETED
|
4
|
6
|
|
First Intervention (3 Weeks)
NOT COMPLETED
|
1
|
1
|
|
Second Intervention (3 Weeks)
STARTED
|
4
|
6
|
|
Second Intervention (3 Weeks)
Received Intervention
|
4
|
6
|
|
Second Intervention (3 Weeks)
COMPLETED
|
4
|
6
|
|
Second Intervention (3 Weeks)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Powered Ankle Prosthesis, Then Unpowered Prosthesis
In this condition, the participant was fitted with a powered prosthetic ankle by a certified prosthetist to start the study. The ankle is the BiOM which is manufactured by Bionx (which used to be named iWalk). This device was given 510(K) Exempt status by the FDA under (regulation number: 890.3500). Participants had at least one week to acclimate to the prosthesis. They then will wore the device for 2 weeks at home, while their activity was monitored. They then came to the lab for testing. The powered prosthesis was removed and their prescribed prosthetic foot was reattached to their existing socket. They then wore their prescribed prosthesis for 2 weeks, while their activity was monitored, before returning to the lab for testing.
|
Unpowered Prosthesis, Then Powered Ankle Prosthesis
In this arm, participants will start in their clinically prescribed dynamic response foot. They first wore their prescribed prosthesis for 2 weeks, while their activity was monitored. They then came to the laboratory for testing. Participants were then fitted with a powered prosthetic ankle by a certified prosthetist. The ankle is the BiOM which is manufactured by Bionx (which used to be named iWalk). This device was given 510(K) Exempt status by the FDA under (regulation number: 890.3500). Participants had at least one week to acclimate to the prosthesis. They then will wore the device for 2 weeks at home, while their activity was monitored. They then came to the lab for testing. The powered prosthesis was removed and their prescribed prosthetic foot was reattached to their existing socket.
|
|---|---|---|
|
First Intervention (3 Weeks)
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
Determining the Potential Benefit of Powered Prostheses
Baseline characteristics by cohort
| Measure |
All Study Participants
n=12 Participants
This group represents all participants enrolled in the study.
|
|---|---|
|
Age, Continuous
|
50.27 years
STANDARD_DEVIATION 13.21 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 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
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 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
|
PRIMARY outcome
Timeframe: Testing took place after wearing the prostheses for two weeksPopulation: Each participant wore both study prostheses. One participant was excluded from analysis as he was not able to reach steady-state energetics on a treadmill
Metabolic costs will be measured using a portable metabolic system when participants walk on a treadmill at a fixed speed.
Outcome measures
| Measure |
Unpowered Prosthesis
n=9 Participants
This condition is any unpowered prosthesis that was clinically prescribed to the patient
|
BiOM Powered Prosthesis
n=9 Participants
This device is a prosthetic ankle which is battery powered and supplies active ankle power.
|
|---|---|---|
|
Metabolic Cost of Walking
|
0.409 J/Nm
Standard Deviation 0.040
|
0.397 J/Nm
Standard Deviation 0.078
|
PRIMARY outcome
Timeframe: 2 weeksPopulation: Each participant in the study wore both prostheses
Activity data we be collected using activity monitors and GPS with both the regular prosthesis and the powered ankle prosthesis. Each activity monitoring period will last 2 weeks and will be done within in a 2 month period. Daily step count taken outside of the home, determined using an activity monitor and GPS device
Outcome measures
| Measure |
Unpowered Prosthesis
n=10 Participants
This condition is any unpowered prosthesis that was clinically prescribed to the patient
|
BiOM Powered Prosthesis
n=10 Participants
This device is a prosthetic ankle which is battery powered and supplies active ankle power.
|
|---|---|---|
|
Total Steps Outside the Home Over a Two Week Period
|
2030 steps
Standard Deviation 1440
|
1640 steps
Standard Deviation 1100
|
PRIMARY outcome
Timeframe: Questionnaire completed 2 weeks after wearing each prosthesisPopulation: Each participant in the study wore both prostheses
Participants completed the Medical Outcomes Study 36 Items Short-Form Health Survey (SF-36) after each condition. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
Outcome measures
| Measure |
Unpowered Prosthesis
n=10 Participants
This condition is any unpowered prosthesis that was clinically prescribed to the patient
|
BiOM Powered Prosthesis
n=10 Participants
This device is a prosthetic ankle which is battery powered and supplies active ankle power.
|
|---|---|---|
|
Quality of Life (QoL) on a Short-Form 36
Physical Component Score
|
62.9 scores on a scale
Standard Deviation 17.5
|
59.4 scores on a scale
Standard Deviation 22
|
|
Quality of Life (QoL) on a Short-Form 36
Mental Component Score
|
63.6 scores on a scale
Standard Deviation 19.1
|
67.4 scores on a scale
Standard Deviation 24.0
|
SECONDARY outcome
Timeframe: Questionnaire completed 2 weeks after wearing each prosthesisPopulation: Each participant wore both study prostheses.
Participants completed a survey to evaluate their prosthetic satisfaction (Prosthetic Evaluation Questionnaire) after each condition. Most questions in the PEQ use a visual analog scale format. Each visual analog scale is scored as a continuous numerical variable measured as the distance in millimeters from the left endpoint of the line (0 mm) to the point at which the respondent's mark crosses the line (up to 100 mm). The questions are all worded so that a higher number (toward the right) will correspond with a more positive response. Ambulation - Greater number = increased perceived ambulation Appearance - Greater number = better appearance Frustration - Greater number = less frustration Perceived Response - Greater number = increased perceived response Residual Limb Health - Greater number = better residual limb health Social burden - Greater number = less social burden Sounds - Greater number = less sound Utility - Greater
Outcome measures
| Measure |
Unpowered Prosthesis
n=10 Participants
This condition is any unpowered prosthesis that was clinically prescribed to the patient
|
BiOM Powered Prosthesis
n=10 Participants
This device is a prosthetic ankle which is battery powered and supplies active ankle power.
|
|---|---|---|
|
Prosthetic Evaluation Questionnaire (PEQ)
Ambulation
|
75.2 scores on a scale
Standard Deviation 18.3
|
84.0 scores on a scale
Standard Deviation 15.8
|
|
Prosthetic Evaluation Questionnaire (PEQ)
Appearance
|
85.6 scores on a scale
Standard Deviation 9.58
|
80.6 scores on a scale
Standard Deviation 12.8
|
|
Prosthetic Evaluation Questionnaire (PEQ)
Frustration
|
66.8 scores on a scale
Standard Deviation 29.7
|
84.8 scores on a scale
Standard Deviation 27.8
|
|
Prosthetic Evaluation Questionnaire (PEQ)
Perceived Response
|
87.6 scores on a scale
Standard Deviation 20.7
|
97.1 scores on a scale
Standard Deviation 4.33
|
|
Prosthetic Evaluation Questionnaire (PEQ)
Residual Limb Health
|
73.6 scores on a scale
Standard Deviation 19.4
|
79.9 scores on a scale
Standard Deviation 14.3
|
|
Prosthetic Evaluation Questionnaire (PEQ)
Social Burden
|
85.2 scores on a scale
Standard Deviation 19.5
|
91.6 scores on a scale
Standard Deviation 15.3
|
|
Prosthetic Evaluation Questionnaire (PEQ)
Sounds
|
71.4 scores on a scale
Standard Deviation 27.1
|
57.2 scores on a scale
Standard Deviation 31.5
|
|
Prosthetic Evaluation Questionnaire (PEQ)
Utility
|
73.1 scores on a scale
Standard Deviation 14.8
|
74.4 scores on a scale
Standard Deviation 16.7
|
|
Prosthetic Evaluation Questionnaire (PEQ)
Well-Being
|
72.9 scores on a scale
Standard Deviation 26.9
|
79.2 scores on a scale
Standard Deviation 22.0
|
SECONDARY outcome
Timeframe: Testing took place after the participant wore the prosthesis for 2 weeksPopulation: Each participant wore both study prostheses
Participants walk on a treadmill while muscle activity from various lower limb muscles are monitored using electromyography. We calculated the integrated EMG (iEMG) for each muscle collected as the total activity in that muscle as a percentage of the maximum signal.
Outcome measures
| Measure |
Unpowered Prosthesis
n=9 Participants
This condition is any unpowered prosthesis that was clinically prescribed to the patient
|
BiOM Powered Prosthesis
n=9 Participants
This device is a prosthetic ankle which is battery powered and supplies active ankle power.
|
|---|---|---|
|
Muscle Activity in the Lower Limb
Intact side biceps femoris
|
24.3 percentage of maximum signal
Standard Deviation 5.07
|
24.1 percentage of maximum signal
Standard Deviation 8.83
|
|
Muscle Activity in the Lower Limb
Intact side rectus femoris
|
25.3 percentage of maximum signal
Standard Deviation 4.06
|
28.7 percentage of maximum signal
Standard Deviation 14.1
|
|
Muscle Activity in the Lower Limb
Intact side soleus
|
29.9 percentage of maximum signal
Standard Deviation 6.47
|
28.6 percentage of maximum signal
Standard Deviation 9.11
|
|
Muscle Activity in the Lower Limb
Intact side tibialis anterior
|
28.4 percentage of maximum signal
Standard Deviation 10.2
|
30.4 percentage of maximum signal
Standard Deviation 7.99
|
|
Muscle Activity in the Lower Limb
Residual side biceps femoris
|
27.8 percentage of maximum signal
Standard Deviation 10.8
|
25.9 percentage of maximum signal
Standard Deviation 8.70
|
|
Muscle Activity in the Lower Limb
Residual side rectus femoris
|
38.3 percentage of maximum signal
Standard Deviation 12.2
|
41.3 percentage of maximum signal
Standard Deviation 9.01
|
SECONDARY outcome
Timeframe: Testing took place after wearing the prostheses for two weeksPopulation: Each participant wore both study prostheses
Participants walk on a treadmill at a fast speed until they felt they can no longer continue. The time to fatigue was recorded.
Outcome measures
| Measure |
Unpowered Prosthesis
n=10 Participants
This condition is any unpowered prosthesis that was clinically prescribed to the patient
|
BiOM Powered Prosthesis
n=10 Participants
This device is a prosthetic ankle which is battery powered and supplies active ankle power.
|
|---|---|---|
|
Time to Fatigue
|
14.7 minutes
Standard Deviation 12.1
|
13.2 minutes
Standard Deviation 10.8
|
Adverse Events
Powered Ankle Prosthesis
Unpowered Prosthesis
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place