Clinical trial NCT02864693: Comparative Effectiveness of Microprocessor Controlled and Carbon Fiber Prosthetic Feet in Transtibial Amputees
Official title: Comparative Effectiveness of Microprocessor Controlled and Carbon Fiber Energy Storing and Returning Prosthetic Feet in Persons With Unilateral Transtibial Amputation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amputation
Keywords: Microprocessor Controlled Ankle
Transtibial Amputee
Pacifica LP
Kinnex
Lead sponsor: Ability Prosthetics and Orthotics, Inc.
Sponsor class: INDUSTRY
First posted: 2016-08-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this research is to evaluate benefits of a microprocessor controlled prosthetic ankle-foot device compared to a non-microprocessor controlled or passive carbon fiber prosthetic ankle-foot device.

Detailed description: Recent advancements in microprocessor controlled prosthetic ankle-foot systems have allowed additional functionality for the lower limb amputee, but research into the effectiveness of microprocessor controlled ankle-foot systems has been limited.

In this research study, differences in perceived mobility, functional capabilities and gait parameters between energy storing and returning and microprocessor controlled ankle-foot mechanisms will be identified where they exist. Also a comparison of the initial function with a new system compared to the function after a four week accommodation period will provide insight into the time it takes for the prosthesis user to experience a benefit from a microprocessor ankle-foot.

Eligibility criteria: Inclusion Criteria:

* Unilateral transtibial amputation
* Age 18-99 years old
* Body weight below 275 lbs
* Non-pregnant
* English speaking
* Current user of prosthesis for at least one year
* Wear time 8 hrs/day or more
* MFCL ≥ K-3
* Well-fitting and functioning prosthesis
* No use of ambulatory aide
* Able to tolerate testing protocol
* Able to walk on slopes
* Must, in the opinion of the investigator, be willing and able to complete all aspects of the study, adhere to the study visit schedule and comply with the assessments

Exclusion Criteria:

* Amputation level other than unilateral transtibial
* Age \<18 or \>99 years old
* Body weight above 275 lbs
* Pregnant
* Non-English speaking
* Not current user of prosthesis
* Less than one year use of prosthesis
* Wear time less than 8 hr/day
* MFCL \<K3
* Poor fitting and functioning prosthesis
* Indicating that the socket fit is painful, or unacceptable
* Use of ambulatory aide
* Unable to tolerate testing protocol
* Unable to walk on slopes
* Presence or history of any condition that, in the view of the investigator, places the participant at high risk of poor treatment compliance or of not completing the study
* Any neurologic impairments known to cause gait and/or balance dysfunction

Primary outcomes:
measure: Amputee Mobility Predictor with Prosthesis (AMPPRO)
timeFrame: Collection at baseline
measure: L-Functional Test (L-Test) Baseline
timeFrame: Collection at baseline
measure: 5 times Sit-to-Stand (5 times STS) Baseline
timeFrame: Collection at baseline
measure: 6 minute Timed Walk Test (6m TWT) Baseline
timeFrame: Collection at baseline
measure: Physiological Cost Index (PCI) Baseline
timeFrame: Collection at baseline
measure: Hill Assessment Index (HAI) Baseline
timeFrame: Collection at baseline
measure: 2 Dimensional Video Motion Analysis (2D Video Analysis) Baseline
timeFrame: Collection at baseline
measure: L-Functional Test (L-Test) after 4 weeks
timeFrame: Collection after 4 weeks
measure: 5 times Sit-to-Stand (5 times STS) after 4 weeks
timeFrame: Collection after 4 weeks
measure: 6 minute Timed Walk Test (6m TWT) after 4 weeks
timeFrame: Collection after 4 weeks
measure: Physiological Cost Index (PCI) after 4 weeks
timeFrame: Collection after 4 weeks
measure: Hill Assessment Index (HAI) after 4 weeks
timeFrame: Collection after 4 weeks
measure: 2 Dimensional Video Motion Analysis (2D Video Analysis) after 4 weeks
timeFrame: Collection after 4 weeks
Secondary outcomes:
measure: Orthotic Prosthetic User Survey (OPUS)
timeFrame: Collection after 4 weeks
measure: Prosthesis Evaluation Questionnaire - Mobility Subscale (PEQ-MS)
timeFrame: Collection after 4 weeks
measure: Prosthesis Limb User Survey of Mobility (PLUS-M)
timeFrame: Collection after 4 weeks
measure: Activities-Specific Balance Confidence Scale (ABC)
timeFrame: Collection after 4 weeks
measure: Socket Comfort Score (SCS)
timeFrame: Collection at baseline and after 4 weeks
Other outcomes:
Locations:
city: Hagerstown
country: United States
facility: Ability Prosthetics and Orthotics, Inc. - Hagerstown, MD
state: Maryland
city: Charlotte
country: United States
facility: Ability Prosthetics and Orthotics, Inc. - Charlotte, NC
state: North Carolina
city: York
country: United States
facility: Ability Prosthetics and Orthotics, Inc. - York, PA
state: Pennsylvania
Study officials:
References: