Trials / Completed
CompletedNCT02828982
Determining the Potential Benefit of Powered Prostheses
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 12 (actual)
- Sponsor
- Deanna H Gates · Academic / Other
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Powered ankle prosthesis | This device is a commercially available powered ankle prosthesis, (BioM, Bionx, Bedford, MA) which was given FDA device exempt status. |
| DEVICE | Dynamic Response Foot | This condition is a sham condition as the participant will wear the prosthesis they were clinically prescribed and usually wear. |
Timeline
- Start date
- 2016-07-01
- Primary completion
- 2019-08-01
- Completion
- 2019-08-01
- First posted
- 2016-07-12
- Last updated
- 2022-01-18
- Results posted
- 2020-11-13
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02828982. Inclusion in this directory is not an endorsement.