Back to resultsDetermining the Potential Benefit of Powered Prostheses
Primary Purpose
Unilateral Traumatic Amputation, Amputation, Traumatic
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Powered ankle prosthesis
Dynamic Response Foot
Sponsored by
About this trial
This is an interventional supportive care trial for Unilateral Traumatic Amputation focused on measuring powered ankle prosthesis, activity monitoring, muscle fatigue, below knee amputation
Eligibility Criteria
Inclusion Criteria:
- Adult (over 21 years old), Has unilateral transtibial amputation, has used prosthesis for at least 6 months, is currently using an unpowered prosthesis, can walk unassisted for at least 10 minutes
Exclusion Criteria:
- History of orthopedic or neurologic disorders to their intact limb, history of cardiovascular disease that prevents them from safely completing requested activities, unable to walk for 30 minutes at a time
Sites / Locations
- University of Michigan
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Powered Ankle Prosthesis
Dynamic Response Foot
Arm Description
In this condition, the participant is 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 will wear the device for 2 weeks.
In this arm, participants will wear their clinically prescribed dynamic response foot. This period is 2 weeks long.
Outcomes
Primary Outcome Measures
Metabolic Cost of Walking
Metabolic costs will be measured using a portable metabolic system when participants walk on a treadmill at a fixed speed.
Total Steps Outside the Home Over a Two Week Period
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
Quality of Life (QoL) on a Short-Form 36
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.
Secondary Outcome Measures
Prosthetic Evaluation Questionnaire (PEQ)
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
Muscle Activity in the Lower Limb
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.
Time to Fatigue
Participants walk on a treadmill at a fast speed until they felt they can no longer continue. The time to fatigue was recorded.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02828982
Brief Title
Determining the Potential Benefit of Powered Prostheses
Official Title
Determining the Potential Benefit of Powered Prostheses
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
July 2016 (undefined)
Primary Completion Date
August 2019 (Actual)
Study Completion Date
August 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Deanna H Gates
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The goal of this research is to determine the effectiveness of a powered prosthesis compared to an unpowered prosthesis during short bouts of walking, extended periods of walking (to fatigue), and performance in the community.
Detailed Description
Many individuals are living in the United States with limb loss. With the use of a prosthetic device many individuals can stay active, but most do not achieve a medically desired physical activity level. This creates a risk for cardiovascular disease. It is thought that individuals with amputation walk less because it is more difficult to get around, and recent advances in robotic prosthetic technology may make such activities easier. However, these prostheses have not yet been evaluated to determine their effectiveness during extended periods of walking. Despite the goals in design of new devices it is unclear whether individuals using them are able to incorporate them into making daily activities easier. Therefore, the goal of this research is to determine the effectiveness of a powered prosthesis compared to an unpowered prosthesis during long periods of walking.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unilateral Traumatic Amputation, Amputation, Traumatic
Keywords
powered ankle prosthesis, activity monitoring, muscle fatigue, below knee amputation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Powered Ankle Prosthesis
Arm Type
Experimental
Arm Description
In this condition, the participant is 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 will wear the device for 2 weeks.
Arm Title
Dynamic Response Foot
Arm Type
Sham Comparator
Arm Description
In this arm, participants will wear their clinically prescribed dynamic response foot. This period is 2 weeks long.
Intervention Type
Device
Intervention Name(s)
Powered ankle prosthesis
Intervention Description
This device is a commercially available powered ankle prosthesis, (BioM, Bionx, Bedford, MA) which was given FDA device exempt status.
Intervention Type
Device
Intervention Name(s)
Dynamic Response Foot
Intervention Description
This condition is a sham condition as the participant will wear the prosthesis they were clinically prescribed and usually wear.
Primary Outcome Measure Information:
Title
Metabolic Cost of Walking
Description
Metabolic costs will be measured using a portable metabolic system when participants walk on a treadmill at a fixed speed.
Time Frame
Testing took place after wearing the prostheses for two weeks
Title
Total Steps Outside the Home Over a Two Week Period
Description
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
Time Frame
2 weeks
Title
Quality of Life (QoL) on a Short-Form 36
Description
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.
Time Frame
Questionnaire completed 2 weeks after wearing each prosthesis
Secondary Outcome Measure Information:
Title
Prosthetic Evaluation Questionnaire (PEQ)
Description
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
Time Frame
Questionnaire completed 2 weeks after wearing each prosthesis
Title
Muscle Activity in the Lower Limb
Description
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.
Time Frame
Testing took place after the participant wore the prosthesis for 2 weeks
Title
Time to Fatigue
Description
Participants walk on a treadmill at a fast speed until they felt they can no longer continue. The time to fatigue was recorded.
Time Frame
Testing took place after wearing the prostheses for two weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult (over 21 years old), Has unilateral transtibial amputation, has used prosthesis for at least 6 months, is currently using an unpowered prosthesis, can walk unassisted for at least 10 minutes
Exclusion Criteria:
History of orthopedic or neurologic disorders to their intact limb, history of cardiovascular disease that prevents them from safely completing requested activities, unable to walk for 30 minutes at a time
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deanna H Gates, Ph.D.
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33726802
Citation
Kim J, Wensman J, Colabianchi N, Gates DH. The influence of powered prostheses on user perspectives, metabolics, and activity: a randomized crossover trial. J Neuroeng Rehabil. 2021 Mar 16;18(1):49. doi: 10.1186/s12984-021-00842-2.
Results Reference
derived
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Determining the Potential Benefit of Powered Prostheses
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