EmPOWERing Active Seniors With Energy

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-10

Study Completion Date

2018-07-31

Brief Summary

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

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Detailed Description

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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

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Amputation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

First the patient data is gathered with the subject's own passive prosthetic. Then switched over to the emPOWER Ankle. Third, the patient's prosthetic is switched back to test for carry-over benefits. Then they are put on the emPOWER for a final series of tests.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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emPOWER Ankle (powered prosthesis)

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.

Group Type OTHER

emPOWER Ankle

Intervention Type DEVICE

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.

Subject's own passive prosthesis

Intervention Type DEVICE

Devices will vary. Data gathered will form a baseline.

Interventions

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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.

Intervention Type DEVICE

Subject's own passive prosthesis

Devices will vary. Data gathered will form a baseline.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No