Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Otto Bock Healthcare Products GmbH
With
BionX Medical Technologies, Inc.
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.
Age
55–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Males and females
55 years or older
Subjects with transtibial amputations of either leg at least 1 year prior
Suction or elevated vacuum suspension and Socket Comfort Score of at least 6
Sock fluctuation of ≤ 8 ply per day
K-level rating of 3 or 4 based on the Amputee Mobility Predictor Assessment Tool
Ability to walk at a walking speed of \> 0.75 meters per second
Unilateral amputees (up to 7 bilateral amputees can be included, 1 per site in addition to the unilateral amputees who will be analyzed as a separate sub group)
Foot size: 25-30 cm
Ability to complete a continuous 6-Minute Walk Test
Ability to provide written, informed consent
Ability to complete study visits and study documents
Ability to manage the complexity of a powered device including charging and changing batteries as needed
Ability to read and understand English
You may not be if
Subjects who have never used a prosthetic device
Less than 55 years of age
Weight \<150 lbs. or \> 287 lbs.
Transfemoral amputees
Active sores or ulceration on subject's residual limb
Sore on contralateral foot.
Cuff-link socket suspension
Socket Comfort Score less than 6
Sock fluctuation of \> 8 per day
K level of 1 or 2
Amputation clearance \< 8.625"
History of stroke or TIA that impairs current walking
Recent history of excessive falling defined as more than 2 falls requiring medical assistance in the prior year
Medications potentially affecting balance
Recent hospitalization (within past 3 months)
Cognitive deficiency that would impact ability to charge and change batteries as needed
Clareo Health | EmPOWERing Active Seniors With Energy
