Amputation, Traumatic Clinical Trial
Official title:
Determining the Potential Benefit of Powered Prostheses
NCT number | NCT02828982 |
Other study ID # | HUM00080734 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 2016 |
Est. completion date | August 2019 |
Verified date | January 2022 |
Source | University of Michigan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 12 |
Est. completion date | August 2019 |
Est. primary completion date | August 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan | Ann Arbor | Michigan |
Lead Sponsor | Collaborator |
---|---|
Deanna H Gates |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Metabolic Cost of Walking | Metabolic costs will be measured using a portable metabolic system when participants walk on a treadmill at a fixed speed. | Testing took place after wearing the prostheses for two weeks | |
Primary | 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 | 2 weeks | |
Primary | 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. | Questionnaire completed 2 weeks after wearing each prosthesis | |
Secondary | 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 |
Questionnaire completed 2 weeks after wearing each prosthesis | |
Secondary | 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. | Testing took place after the participant wore the prosthesis for 2 weeks | |
Secondary | 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. | Testing took place after wearing the prostheses for two weeks |
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