EmPOWERing Active Seniors With Energy

Completed · Not applicable

Conditions studied: Amputation

In brief

A pilot study comparing the emPOWER Ankle System to standard carbon fiber prosthetic feet, in active seniors.

Key facts

Study ID

NCT02958553

Run by

Otto Bock Healthcare Products GmbH

People needed

8

Starts

2017-02-10

Expected to finish

2018-07-31

Last updated by the study team

2020-04-24

Who can join

Age: 55 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 qualify 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

Where it is running

• UTHealth, Department of Orthopedic Surgery — Houston, Texas, United States

Full record on ClinicalTrials.gov

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