Prosthetic and Orthotic Clinical Excellence

Status: Currently Enrolling Subjects

Ability Prosthetics and Orthotics, Inc. is seeking eligible patients to participate in a research study.

Participation in the research study is completely voluntary.

 Ability Prosthetics and Orthotics, Inc. is performing a research study to evaluate a self-aligning prosthetic adapter. The goal is to learn whether a recently developed adapter, from Impulse Technology, LLC, provides improvements to walking, socket loads and comfort when compared to walking without the self-aligning adapter.

We are looking for lower limb amputees who meet the following criteria:

• Have a below knee amputation on one side
• Between 18 and 85 years old
• At least 1 year prosthetic experience
• Use prosthesis 8 hours a week or more
• Have well-fitting prosthesis
• English speaking
• Body weight below 275 lbs
• Non-pregnant
• No use of ambulatory aid (no cane or walker)
• Walk unlimited in community (K-level 3 or 4)

By participating in this study, participant’s walking ability with a prosthesis may get better, stay the same, or get worse. A possible risk is wearing a prosthesis patients are not accustomed to could lead to decreased stability and a potential fall. Participation in the research study may improve our understanding of the effects of a self-aligning adapter. Participants will receive compensation for their time during each research visits.

The research study will be performed at up to three visits, each lasting up to a maximum of eight hours. Ability Prosthetics and Orthotics, Inc. will administer the study at the following location:

Ability – Mechanicsburg, PA
2005 Technology Parkway, Suite 200
Mechanicsburg, PA

Ability – York, PA
960 South George Street
York, PA 17403

Ability – Frederick, MD
73 Thomas Johnson Drive, Suite B
Frederick, MD 21702

Ability – Exton, PA
660 West Lincoln Highway
Exton, PA 19341

If interested in participating, please contact the Principal Investigator:

Brian Kaluf, BSE, CP

Clinical Outcome and Research Director

Ability Prosthetics & Orthotics, Inc.

Office:  864-605-3476

Cell: 864-420-9962

Email:  Brian.Kaluf@abilitypo.com

Click the link below to view the flyer:

Self-Aligning Adapter Recruitment Flyer

Ability Prosthetics and Orthotics, Inc. is performing a research study to evaluate the benefits of a Custom Knee Ankle Foot Orthosis (KAFO) with Powered Knee Joint system in patients with lower limb paralysis or weakness. In this study, prototype devices will be fit and programmed to participants with limited capacity to walk without assistance. Walking performance and balance with the powered KAFO will be tested, and the results will be used to inform the future adjustments/improvements to the product design. Participation in the research study is completely voluntary.

We are looking for persons who meet the following criteria:

• Weakness of the lower extremity on one or both sides of the body
  • Knee instability
  • Quadriceps weakness
  • Paralysis
• Manual Muscle Test knee extensor strength 2 out of 5 or
  greater, if weakness on both sides
• Manual Muscle Test hip flexor score strength 2 out of 5 or
  greater
• Age 18‐65 years old
• Non‐pregnant
• English speaking
• Able to follow directions to comply with the testing protocol
• Free of cognitive disorders
• Free of visual impairment
• Weight ≤ 250 lbs

By participating in this study, your walking ability may get better, stay the same, or get worse. Possible risks related to wearing a powered KAFO include: skin breakdown, falls and joint misalignment. Your participation in the research study may assist in developing an improved understanding about the benefits of powered KAFO in persons with lower extremity weakness. You will receive $100 compensation for each research visit. The research study will be performed over a series of four or five visits, each lasting about four hours. Participants will not be allowed to keep the powered KAFO upon completion of the study. Ability
Prosthetics and Orthotics, Inc. will administer the study at the following location:

Asheville, NC
3 Walden Ridge Drive,
Suite 400
Asheville, NC 28803

Charlotte, NC
309 S. Sharon Amity Road,
Suite 104
Charlotte, NC 28211

Ability ‐ Exton, PA
660 West Lincoln Highway
Exton, PA 19341

Ability ‐ Frederick, MD
73 Thomas Johnson Drive,
Suite B
Frederick, MD 21702

Ability ‐ Hagerstown, MD
246 Eastern Blvd,
Suite 100
Hagerstown, MD 21740

Ability ‐ Hanover, PA
250 Fame Avenue, Suite 102
Entrance C
Hanover, PA 17331

Ability ‐ Limerick, PA
410 W. Linfield Trappe Road, Suite 110
Royersford, PA 19468
Ability ‐ Mechanicsburg, PA
2005 Technology Parkway,
Suite 200

Mechanicsburg, PA 17050
Ability ‐ Rockville, MD
15200 Shady Grove Road,
Suite 102
Rockville, MD 20850

Ability ‐ York, PA
960 South George Street
York, PA 17403

If interested in participating, please contact the Principal Investigator:
Brian Kaluf, BSE, CP
Clinical Outcome and Research Director
Ability Prosthetics & Orthotics, Inc.
Phone: 864‐552‐1840
Email: Brian.Kaluf@abilitypo.com

Status: Currently Enrolling Subjects

Ability P&O and Clemson University is seeking eligible participants to participate in a research study.

Participation in the research study is completely voluntary.

Clemson University is performing a research study to evaluate a novel prosthetic insert for lower limb prosthetic sockets. The goal of the study is to determine whether the novel insert provides reduced interface pressure in the socket and improved comfort compared to sockets without the insert. We are looking for lower limb amputees who meet the following criteria:

• Have a below the knee amputation on one side
• Between 18 & 85 years old
• At least 6 months prosthetic experience
• Use prosthesis 10 hours a week or more
• Have a well-fitting prosthesis
• English speaking
• Body weight below 275 pounds
• Non-pregnant
• K-2 or higher

By participating in this study, participant’s walking ability with a prosthesis may get better, stay the same, or get worse. Possible risks include that wearing a prosthesis that patients are not accustomed to could lead to decreased stability and potential fall. Participation in the research study may improve our understanding of the effects of the novel insert. Participants will receive compensation for their time during research visits.

The research study will be performed during up to 8 visits, each lasting a maximum of four hours. Clemson University will administer the study at the following locations:

Ability – Charlotte, NC

309 S. Sharon Amity Road, Suite 104 Charlotte, NC 28211

Ability – Asheville, NC

3 Walden Ridge Drive, Suite 400 Asheville, NC 28803

If interested in participating in the study, please contact Meredith Owen or Brian Kaluf

Meredith Owen

Clemson University

Cell: 864-508-6571

Email: mko@g.clemson.edu

Brian Kaluf, BSE, CP

Ability Prosthetics and Orthotics, Inc.

Cell: 864-420-9962

Office: 864-605-3476

Email: brian.kaluf@abilitypo.com

Status: This clinical trial is no longer enrolling new participants.

Our University of Washington research team is working to develop a patient-reported outcome measure for people who use lower limb orthoses (AFOs and KAFOs). We are excited about the impact this instrument could have on our field, as it will be quick to administer, customizable for people with different levels of mobility or conditions, and freely available to practitioners. However, we need your help to develop this new tool.  An important part of the instrument development process is learning from people who use orthotic devices. We are currently looking for people around the country who use an AFO or KAFO, and are willing to participate in one of our upcoming focus groups. Participants can join the focus group discussion using a personal computer or by phone. Focus group discussions will last 1-2 hours, and participants will receive $50 for their participation in the study.

We are seeking people who…

• are 18 years of age or older
• currently use a lower limb orthosis most days of the week (we are including all types of AFOs, KAFOs, or HKAFO; bilateral orthosis users are eligible as well)
• have used an orthosis for more than 6 months
• are willing to participate in a recorded web/video conference call

We currently have two focus groups scheduled and will likely add two more.  Here are the two upcoming dates and times:

• Tuesday, Dec. 4th at 2pm PST (5pm EST)
• Monday, Dec. 10th at 9am PST (12PM EST)

If any of your patients may be interested in this study, or would like to know more, please have them call us at 1-800-504-0564, or email us at uwcorr@uw.edu.  The PI for this study is Geoff Balkman, CPO.

UW OPRO Focus Group Flyer

Status: This clinical trial is completed and is no longer enrolling new participants.

Recent advancements in upper limb prosthesis control have not been evaluated in patients born without a hand (transradial congenital limb difference). Although this represents a large patient population, most recent research has focused on traumatic amputees, instead of those born without a limb. This study was the first to evaluate Pattern Recognition (PR) control of advanced prosthesis with multiple degrees of freedom in this population.

Results from this study are being presented at national academic conferences and submitted for publication in peer reviewed journal articles.

Status: This clinical trial is completed and is no longer enrolling new participants.

Hydraulic and microprocessor control of prosthetic joints are not currently available for patients categorized as MFCL K1 or K2, yet the function provided by these technologies may benefit this patient population. The aim of this pilot study is to examine a diverse set of potential benefits from both hydraulic and microprocessor controlled prosthetic ankles for persons with unilateral transtibial amputation who are classified as K1 or K2. Outcome measures will be collected to examine: self-rated mobility and functional ambulation on level ground, turns and slopes; step activity and cadence variability in the community; balance confidence, fall risk and fall incidence; walking speed and energy consumption; and socket comfort and lower back pain. The results from this study will potentially highlight the negative effects of restricting access to these technologies within this patient population and can motivate larger studies into the benefits of hydraulic and microprocessor control of prosthetic joints in amputees who have limited capacity for community ambulation.

Status: Recruitment for this clinical trial will begin in Fall of 2017

Status: This clinical trial is completed and is no longer enrolling new participants.

We are performing research to compare the benefits of two prosthetic ankle-foot devices. This research will help us learn whether a recently developed microprocessor-controlled prosthetic ankle-foot device, called the Kinnex, provides an advantage to walking and increased mobility when compared to a carbon fiber prosthetic ankle-foot device called the Pacifica LP. Both prosthetic ankle-foot devices are manufactured by Freedom Innovations, LLC (Irvine, CA).

Status: The clinical trial is completed and is no longer enrolling new participants

In partnership with the University of Washington, patients were recruited for a grant funded research project to evaluate the use of continuous inter-socket residual limb volume measurement, using a biompedence based sensor system. The study randomly assigned participants into two groups, those whose prothesist received the information from the biompedence sensor system and those who did not. Participants received new prosthetic sockets and outcomes related to residual limb socket fit were assessed.

Results from this study are being presented at national academic conferences and submitted for publication in peer reviewed journal articles.

Status: The clinical trial is completed and is no longer enrolling new participants

In partnership with Clemson University, a patented 3D printing technology was applied to the prosthetic socket for a single trantibial amputee subject. Pressure sensors and patient-reported outcome measures compared a traditional socket from the 3D printed inlay socket. These results further informed the design and development of this novel prosthetic socket technology.

Results from this study were presented at a national academic conference and have been submitted for publication in a peer reviewed journal article.