AmputationNCT02864693
Comparative Effectiveness of Microprocessor Controlled and Carbon Fiber Prosthetic Feet in Transtibial Amputees
A study testing Kinnex and Pacifica LP in people with Amputation, run by Ability Prosthetics and Orthotics, Inc. at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Amputation
- What is being tested?
- Kinnex and Pacifica LP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2016to Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Ability Prosthetics and Orthotics, Inc. - Charlotte, NC
Charlotte, North Carolina, 28211
Ability Prosthetics and Orthotics, Inc. - Hagerstown, MD
Hagerstown, Maryland, 21740
Ability Prosthetics and Orthotics, Inc. - York, PA
York, Pennsylvania, 17403
About this study
Official title: Comparative Effectiveness of Microprocessor Controlled and Carbon Fiber Energy Storing and Returning Prosthetic Feet in Persons With Unilateral Transtibial Amputation
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.
Read the 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.
- Conditions
- Amputation
- Being tested
- Kinnex, Pacifica LP
- Keywords
- Microprocessor Controlled Ankle, Transtibial Amputee, Pacifica LP, Kinnex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KinnexDevice
The Kinnex is a microprocessor controlled hydraulic ankle foot device (Freedom Innovations, Irvine, CA).
Pacifica LPDevice
The Pacifica LP is a carbon-fiber ankle foot device (Freedom Innovations, Irvine, CA)
| Study group | Role | What they receive |
|---|---|---|
| Configuration A (Kinnex) | Active comparator | Not described Receives: Device: Kinnex |
| Configuration B (Pacifica LP) | Active comparator | Not described Receives: Device: Pacifica LP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amputee Mobility Predictor with Prosthesis (AMPPRO)
The AMPPRO is a functional test consisting of 21 tasks that are similar to everyday function to test balance, strength and walking ability
Measured: Collection at baseline
L-Functional Test (L-Test) Baseline
The L-test is a timed functional test that involves standing from a chair, walking 3 meters, turning around and sitting back into the chair.
Measured: Collection at baseline
5 times Sit-to-Stand (5 times STS) Baseline
The 5 times STS is a timed functional test that measures how long it takes to stand and sit five times in a row from a chair.
Measured: Collection at baseline
6 minute Timed Walk Test (6m TWT) Baseline
The 6m TWT involves walking as far as possible along a straight path between two cones in under 6 minutes.
Measured: Collection at baseline
Physiological Cost Index (PCI) Baseline
The PCI is calculated by subtracting resting heart rate from active heart rate following a walking test, and dividing the difference by the walking speed.
Measured: Collection at baseline
Hill Assessment Index (HAI) Baseline
The HAI is a functional test that measures quality of walking up and down a sloped ramp.
Measured: Collection at baseline
2 Dimensional Video Motion Analysis (2D Video Analysis) Baseline
2D Video Analysis will be used to measure knee and ankle angles at mid-stance of gait while walking up and down the sloped ramp and also while standing still on level ground.
Measured: Collection at baseline
L-Functional Test (L-Test) after 4 weeks
The L-test is a timed functional test that involves standing from a chair, walking 3 meters, turning around and sitting back into the chair.
Measured: Collection after 4 weeks
5 times Sit-to-Stand (5 times STS) after 4 weeks
The 5 times STS is a timed functional test that measures how long it takes to stand and sit five times in a row from a chair.
Measured: Collection after 4 weeks
6 minute Timed Walk Test (6m TWT) after 4 weeks
The 6m TWT involves walking as far as possible along a straight path between two cones in under 6 minutes.
Measured: Collection after 4 weeks
Physiological Cost Index (PCI) after 4 weeks
The PCI is calculated by subtracting resting heart rate from active heart rate following a walking test, and dividing the difference by the walking speed.
Measured: Collection after 4 weeks
Hill Assessment Index (HAI) after 4 weeks
The HAI is a functional test that measures quality of walking up and down a sloped ramp.
Measured: Collection after 4 weeks
2 Dimensional Video Motion Analysis (2D Video Analysis) after 4 weeks
2D Video Analysis will be used to measure knee and ankle angles at mid-stance of gait while walking up and down the sloped ramp and also while standing still on level ground.
Measured: Collection after 4 weeks
Secondary outcomes (5)
Orthotic Prosthetic User Survey (OPUS)
The OPUS is a self-reported questionnaire that asks about satisfaction with device
Measured: Collection after 4 weeks
Prosthesis Evaluation Questionnaire - Mobility Subscale (PEQ-MS)
The PEQ-MS is a self-reported questionnaire that measures perceived difficulty ambulating on a variety of environmental barriers
Measured: Collection after 4 weeks
Prosthesis Limb User Survey of Mobility (PLUS-M)
The PLUS-M is a self-reported questionnaire that measures perceived mobility with a prosthesis in different environments.
Measured: Collection after 4 weeks
Activities-Specific Balance Confidence Scale (ABC)
The ABC is a self-reported questionnaire that measures confidence in balance while performing various activities in different environments.
Measured: Collection after 4 weeks
Socket Comfort Score (SCS)
The SCS is a self-reported questionnaire that asks the participant to rate their current socket comfort from 0-10, with 10 points representing the most comfortable socket they can imagine.
Measured: Collection at baseline and after 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2016 (estimated)
- Study startJun 2016
- Primary completionAug 2017
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmputationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ability Prosthetics and Orthotics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Brian Kaluf BSE, CP, Ability Prosthetics and Orthotics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02864693
- Sponsor's protocol ID
- FI-001
- Status last verified
- Jul 2018
- First submitted
- 4 Aug 2016
- Last updated
- 10 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Microprocessor Controlled and Carbon Fiber Energy Storing and Returning Prosthetic Feet in Persons With Unilateral Transtibial Amputation
- ClinicalTrials.gov ID
- NCT02864693
- Acronym / sponsor ID
- FI-001
- Conditions
- Amputation
- Keywords
- Microprocessor Controlled Ankle, Transtibial Amputee, Pacifica LP, Kinnex
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ability Prosthetics and Orthotics, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2016 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 12 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Configuration A (Kinnex) | Active comparator | Device: Kinnex |
| Configuration B (Pacifica LP) | Active comparator | Device: Pacifica LP |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Unilateral transtibial amputation
- Age 18-99 years old
- Body weight below 275 lbs
- Non-pregnant
- English speaking
Key exclusion criteria (16 listed)
- Amputation level other than unilateral transtibial
- Age <18 or >99 years old
- Body weight above 275 lbs
- Pregnant
- Non-English speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KinnexThe Kinnex is a microprocessor controlled hydraulic ankle foot device (Freedom Innovations, Irvine, CA). | Device | Configuration A (Kinnex) |
| Pacifica LPThe Pacifica LP is a carbon-fiber ankle foot device (Freedom Innovations, Irvine, CA) | Device | Configuration B (Pacifica LP) |
Primary outcome
Amputee Mobility Predictor with Prosthesis (AMPPRO)
Time frame: Collection at baseline
The AMPPRO is a functional test consisting of 21 tasks that are similar to everyday function to test balance, strength and walking ability
L-Functional Test (L-Test) Baseline
Time frame: Collection at baseline
The L-test is a timed functional test that involves standing from a chair, walking 3 meters, turning around and sitting back into the chair.
5 times Sit-to-Stand (5 times STS) Baseline
Time frame: Collection at baseline
The 5 times STS is a timed functional test that measures how long it takes to stand and sit five times in a row from a chair.
6 minute Timed Walk Test (6m TWT) Baseline
Time frame: Collection at baseline
The 6m TWT involves walking as far as possible along a straight path between two cones in under 6 minutes.
Physiological Cost Index (PCI) Baseline
Time frame: Collection at baseline
The PCI is calculated by subtracting resting heart rate from active heart rate following a walking test, and dividing the difference by the walking speed.
Hill Assessment Index (HAI) Baseline
Time frame: Collection at baseline
The HAI is a functional test that measures quality of walking up and down a sloped ramp.
2 Dimensional Video Motion Analysis (2D Video Analysis) Baseline
Time frame: Collection at baseline
2D Video Analysis will be used to measure knee and ankle angles at mid-stance of gait while walking up and down the sloped ramp and also while standing still on level ground.
L-Functional Test (L-Test) after 4 weeks
Time frame: Collection after 4 weeks
The L-test is a timed functional test that involves standing from a chair, walking 3 meters, turning around and sitting back into the chair.
5 times Sit-to-Stand (5 times STS) after 4 weeks
Time frame: Collection after 4 weeks
The 5 times STS is a timed functional test that measures how long it takes to stand and sit five times in a row from a chair.
6 minute Timed Walk Test (6m TWT) after 4 weeks
Time frame: Collection after 4 weeks
The 6m TWT involves walking as far as possible along a straight path between two cones in under 6 minutes.
Physiological Cost Index (PCI) after 4 weeks
Time frame: Collection after 4 weeks
The PCI is calculated by subtracting resting heart rate from active heart rate following a walking test, and dividing the difference by the walking speed.
Hill Assessment Index (HAI) after 4 weeks
Time frame: Collection after 4 weeks
The HAI is a functional test that measures quality of walking up and down a sloped ramp.
2 Dimensional Video Motion Analysis (2D Video Analysis) after 4 weeks
Time frame: Collection after 4 weeks
2D Video Analysis will be used to measure knee and ankle angles at mid-stance of gait while walking up and down the sloped ramp and also while standing still on level ground.
5 secondary outcomes
Orthotic Prosthetic User Survey (OPUS)
Time frame: Collection after 4 weeks
Prosthesis Evaluation Questionnaire - Mobility Subscale (PEQ-MS)
Time frame: Collection after 4 weeks
Prosthesis Limb User Survey of Mobility (PLUS-M)
Time frame: Collection after 4 weeks
Activities-Specific Balance Confidence Scale (ABC)
Time frame: Collection after 4 weeks
Socket Comfort Score (SCS)
Time frame: Collection at baseline and after 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinnex and Pacifica LP in people with Amputation, run by Ability Prosthetics and Orthotics, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amputee Mobility Predictor with Prosthesis (AMPPRO) (time frame: Collection at baseline). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2018.