EmPOWERing Active Seniors With Energy (EASE)

Otto Bock Healthcare (Ottobock)

Status: Completed

Conditions: Amputation

Treatments: Device: emPOWER Ankle; Device: Subject's own passive prosthesis

Study type: Interventional

Funder types: Industry

Identifiers

NCT02958553

P16-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

emPOWER Ankle (powered prosthesis)

Other group

Description:

The subject's own passive prosthesis will be used as a baseline and crossed over after the emPOWER has been worn 3-4 months. Then the passive foot will be crossed back to the emPOWER for a final series of tests.

Treatment:

Device: Subject's own passive prosthesis

Device: emPOWER Ankle