EmPOWERing Active Seniors With Energy

NCT02958553 | Completed Results FDA Device

• 1 other identifier: P16-01
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Amputation

Keywords

Lower Extremity Limb Loss; Prosthesis Use

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Improvement, No Change, or Worsening in Performance in the Six Minute Walk Test (6MWT)

  The proportion of patients with a clinically meaningful change (improvement, no change, worsening) in the walking distance measured by the Six Minute Walk Test (6MWT). 6minWT improvement was defined as a minimum increase of 45 meters.

  3 months with the emPOWER ankle

Secondary Outcomes (15)

• Number of Participants With Improvement, No Change, or Worsening in Performance in the Twelve Minute Walk Test (12MWT)

  3 months with the emPOWER ankle

• Number of Participants With Improvement, No Change, or Worsening in Performance in the 10 Meter Walk Test (10MWT)

  3 months with the emPOWER ankle

• Number of Participants With Improvement, No Change, or Worsening in Performance in the L-Test

  3 months with the emPOWER ankle

• Number of Participants With Improvement, No Change, or Worsening in Performance in the Ramp Test

  3 months with the emPOWER ankle

• Number of Participants With Improvement, No Change, or Worsening in Performance in the Activities-specific Balance Confidence (ABC) Scale Score

  3 months with the emPOWER ankle

Other Outcomes (1)

• Activity Diary

  3 months

Study Arms (1)

emPOWER Ankle (powered prosthesis)

OTHER

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.

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

Interventions

emPOWER Ankle 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.

emPOWER Ankle (powered prosthesis)

Subject's own passive prosthesis DEVICE

Devices will vary. Data gathered will form a baseline.

emPOWER Ankle (powered prosthesis)

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females
• 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)

Sponsors & Collaborators

• Otto Bock Healthcare Products GmbH: lead
• BionX Medical Technologies, Inc.: collaborator

Study Sites (1)

UTHealth, Department of Orthopedic Surgery

Houston, Texas, 77030, United States

Location

Results Point of Contact

• Title: Russ Lundstrom
• Organization: Ottobock Healthcare

russ.lundstrom@ottobock.com

512-806-2606

Study Officials

• Danielle Melton, M.D.

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 2, 2016
• First Posted: November 8, 2016
• Study Start: February 10, 2017
• Primary Completion: July 31, 2018
• Study Completion: July 31, 2018
• Last Updated: April 24, 2020
• Results First Posted: April 9, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)