Trials / Completed
CompletedNCT02958553
EmPOWERing Active Seniors With Energy
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 8 (actual)
- Sponsor
- Otto Bock Healthcare Products GmbH · Industry
- Sex
- All
- Age
- 55 Years
- Healthy volunteers
- Not accepted
Summary
A pilot study comparing the emPOWER Ankle System to standard carbon fiber prosthetic feet, in active seniors.
Detailed description
The primary objective of this study is to characterize the increase in the distance subjects can walk during a six (6) minute period while wearing the emPOWER Ankle compared to a passive lower-extremity prosthesis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | 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. |
| DEVICE | Subject's own passive prosthesis | Devices will vary. Data gathered will form a baseline. |
Timeline
- Start date
- 2017-02-10
- Primary completion
- 2018-07-31
- Completion
- 2018-07-31
- First posted
- 2016-11-08
- Last updated
- 2020-04-24
- Results posted
- 2020-04-09
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT02958553. Inclusion in this directory is not an endorsement.